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most commonly observed adverse reactions in cymbalta-treated patients (as defined above) were nausea, fatigue, constipation, dry mouth, insomnia, somnolence, and dizziness. after 7 weeks of treatment, cymbalta patients with less than 30% reduction in average daily pain and who were able to tolerate cymbalta 60 mg once daily had their dose of cymbalta, in a double-blinded fashion, increased to 120 mg once daily for the remainder of the study. the most common side effects of cymbalta are nausea, dry mouth, constipation, diarrhea, fatigue, drowsiness, difficulty sleeping, loss of appetite, and dizziness.% (117/906) of the patients who received cymbalta in placebo-controlled trials for dpnp discontinued treatment due to an adverse reaction, compared with 5. if you notice other effects not listed above, contact your doctor or pharmacist. in clinical trials of all indications, 34,756 patients were treated with cymbalta. there may be circumstances when it is necessary to initiate treatment with an maoi such as linezolid or intravenous methylene blue in a patient taking cymbalta. is a list of treatment-emergent adverse reactions reported by patients treated with cymbalta in clinical trials. consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of cymbalta (e.% (79/503) of the patients who received cymbalta in 13-week, placebo-controlled trials for chronic pain due to oa discontinued treatment due to an adverse reaction, compared with 7.. abnormal bleeding: cymbalta and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (coumadin, jantoven), a non-steroidal anti-inflammatory drug (nsaids, like ibuprofen or naproxen), or aspirin. your healthcare provider may need to change the dose of cymbalta until it is the right dose for you. 4 gives the incidence of treatment-emergent adverse events that occurred in 2% or more of patients treated with cymbalta (determined prior to rounding) in the premarketing acute phase of dpnp, fm, oa, and clbp placebo-controlled trials and with an incidence greater than placebo.)] and in patients taking cymbalta at doses above 60 mg daily. treatment in placebo-controlled clinical trials across approved indications, was associated with small mean increases from baseline to endpoint in alt, ast, cpk, and alkaline phosphatase; infrequent, modest, transient, abnormal values were observed for these analytes in cymbalta-treated patients when compared with placebo-treated patients [see warnings and precautions (5. in studies up to 9 months, cymbalta-treated pediatric patients experienced an increase in height of 1. in clinical trials of all indications, 34,756 patients were treated with cymbalta. of cymbalta in a child or adolescent must balance the potential risks with the clinical need [see boxed warning and warnings and precautions (5. the right doctordiagnosing fibromyalgiacommon misdiagnoses of fibromyalgiadrugs, alternative remedies, and lifestyle habitsfibromyalgia medicationsis cymbalta right for you? — use of cymbalta concomitantly with heavy alcohol intake may be associated with severe liver injury. pediatric patients treated with cymbalta in clinical trials experienced a 0. patients taking cymbalta experienced a statistically significantly longer time to relapse of gad than did patients taking placebo (study 4 in figure 2). cymbalta has not been systematically studied in humans for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. your doctor right away if any of these serious side effects occur: confusion, easy bruising/bleeding, decreased interest in sex, changes in sexual ability, muscle cramps/weakness, shaking (tremor), difficulty urinating, unusual decrease in the amount of urine, signs of liver problems (such as stomach/abdominal pain, persistent nausea, vomiting, yellowing eyes/skin, dark urine). cymbalta is a medication approved to manage the unique symptoms of fibromyalgia. 6 provides the incidence of treatment-emergent adverse reactions in mdd and gad pediatric placebo-controlled trials that occurred in greater than 2% of patients treated with cymbalta and with an incidence greater than placebo. common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (cymbalta 2. bleeding — caution patients about the concomitant use of cymbalta and nsaids, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see warnings and precautions (5. is the most important information i should know about duloxetine (cymbalta)? you may report side effects to fda at 1-800-fda-1088. do not use cymbalta for a condition for which it was not prescribed. efficacy of cymbalta in the treatment of patients ≥65 years of age with generalized anxiety disorder was established in one 10-week flexible-dose, randomized, double-blind, placebo-controlled trial in adults ≥65 years of age meeting the dsm-iv criteria for gad. patients of the following issues and ask them to alert their prescriber if these occur while taking cymbalta. — although cymbalta does not increase the impairment of mental and motor skills caused by alcohol, use of cymbalta concomitantly with heavy alcohol intake may be associated with severe liver injury.

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in a clinical pharmacology study designed to evaluate the effects of cymbalta on various parameters, including blood pressure at supratherapeutic doses with an accelerated dose titration, there was evidence of increases in supine blood pressure at doses up to 200 mg twice daily. patients were initially treated with cymbalta 60 mg once daily for eight weeks in open-label fashion. pediatric patients treated with cymbalta in clinical trials experienced a 0.-closure glaucoma — advise patients that taking cymbalta can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. common side effects may include:dry mouth;drowsiness;tired feeling;mild nausea or loss of appetite; orconstipation. of cymbalta with other maois such as linezolid or methylene blue.% (99/600) of the patients who received cymbalta in 13-week, placebo-controlled trials for clbp discontinued treatment due to an adverse reaction, compared with 6. many people using this medication do not have serious side effects. stopping cymbalta too quickly or changing from another antidepressant too quickly may result in serious symptoms including:Feeling tired or problems sleeping. cymbalta exactly as your healthcare provider tells you to take it. treatment in placebo-controlled clinical trials across approved indications, was associated with small mean increases from baseline to endpoint in alt, ast, cpk, and alkaline phosphatase; infrequent, modest, transient, abnormal values were observed for these analytes in cymbalta-treated patients when compared with placebo-treated patients [see warnings and precautions].% (319/3779) of the patients who received cymbalta in placebo-controlled trials for mdd discontinued treatment due to an adverse reaction, compared with 4. patients on cymbalta experienced a statistically significantly longer time to relapse of depression than did patients on placebo (study 5 in figure 1). the types of adverse reactions observed with cymbalta in children and adolescents were generally similar to those observed in adults. therefore, caution patients about operating hazardous machinery including automobiles, until they are reasonably certain that cymbalta therapy does not affect their ability to engage in such activities. these effects were observed at the high dose of 45 mg/kg/day (2 times the mrhd, for a child); the no-effect-level was 20 mg/kg/day (≈1 times the mrhd, for a child). should i discuss with my healthcare provider before taking duloxetine (cymbalta)? inhibitors — co-administration of cymbalta with potent cyp1a2 inhibitors should be avoided [see drug interactions (7. cymbalta appears to be associated with concentration-dependent but not clinically meaningful qt shortening. is not a complete list of side effects and others may occur. in studies up to 9 months, cymbalta-treated pediatric patients experienced an increase in height of 1. after 7 weeks of treatment with cymbalta 60 mg once daily, in oa-1 patients with sub-optimal response to treatment (<30% pain reduction) and tolerated cymbalta 60 mg once daily had their dose increased to 120 mg. — inform patients that severe liver problems, sometimes fatal, have been reported in patients treated with cymbalta.., discontinuation occurring in at least 1% of the cymbalta-treated patients and at a rate of at least twice that of placebo). not start cymbalta in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. males treated with cymbalta experienced more difficulty with ability to reach orgasm (asex item 4) than males treated with placebo. cymbalta in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2. for fibromyalgia: benefits and side effectssavella for fibromyalgia treatmentfibromyalgia and physical therapy. low back pain — the most commonly observed adverse reactions in cymbalta-treated patients (as defined above) were nausea, dry mouth, insomnia, somnolence, constipation, dizziness, and fatigue. in a published study, lactating women who were weaning their infants were given cymbalta. for this reason, cymbalta should not be prescribed for patients with substantial alcohol use [see warnings and precautions (5. summary — there are no adequate and well-controlled studies of cymbalta administration in pregnant women. 3 gives the incidence of treatment-emergent adverse reactions in mdd and gad placebo-controlled trials for approved indications that occurred in 2% or more of patients treated with cymbalta and with an incidence greater than placebo. reactions occurring at an incidence of 2% or more among cymbalta-treated patients in adult placebo-controlled trials.

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have trigeminal neuropathy plus tmj i get locked jaw all the time my pain is in my left side in my top teeth hurts pretty sometimes pretty bad an forehead pain i have had mine for over a year im on medication but there are side effects but im managing. — the most commonly observed adverse reactions in cymbalta-treated patients (as defined above) were nausea, dry mouth, constipation, somnolence, decreased appetite, hyperhidrosis, and agitation. males treated with cymbalta experienced more difficulty with ability to reach orgasm (asex item 4) than males treated with placebo. data are available on the effects of duloxetine in patients with end-stage renal disease (esrd). are encouraged to report negative side effects of prescription drugs to the fda. specific pharmacokinetic study was conducted to investigate the effects of race. cases with serum sodium lower than 110 mmol/l have been reported and appeared to be reversible when cymbalta was discontinued. cymbalta at room temperature between 68°f to 77°f (20°c to 25°c). the most commonly reported symptoms following discontinuation of cymbalta in pediatric clinical trials have included headache, dizziness, insomnia, and abdominal pain [see warnings and precautions and adverse reactions reported as reasons for discontinuation of treatment in adult placebo-controlled trials]. efficacy of cymbalta has been established in the following adequate and well-controlled trials:Major depressive disorder (mdd): 4 short-term and 1 maintenance trial in adults [see clinical studies (14. for fibromyalgia: benefits and side effectssavella for fibromyalgia treatmentfibromyalgia and physical therapy. is the most important information i should know about duloxetine (cymbalta)? weight and height should be monitored regularly in children and adolescents treated with cymbalta. cymbalta should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. reactions after discontinuation of cymbalta, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. a total of 457 patients (342 cymbalta, 115 placebo) were enrolled in dpnp-1 and a total of 334 patients (226 cymbalta, 108 placebo) were enrolled in dpnp-2. efficacy of cymbalta in the treatment of generalized anxiety disorder (gad) was established in 1 fixed-dose randomized, double-blind, placebo-controlled trial and 2 flexible-dose randomized, double-blind, placebo-controlled trials in adult outpatients between 18 and 83 years of age meeting the dsm-iv criteria for gad. in three clinical trials of cymbalta for the management of neuropathic pain associated with diabetic peripheral neuropathy, the mean duration of diabetes was approximately 12 years, the mean baseline fasting blood glucose was 176 mg/dl, and the mean baseline hemoglobin a1c (hba1c) was 7. treatment with cymbalta 60 mg or 120 mg daily statistically significantly improved the endpoint mean pain scores from baseline and increased the proportion of patients with at least a 50% reduction in pain score from baseline. i successfully stopped cymbalta cold turkey this past summer (june 2016). subchapter articles:finding the right doctordiagnosing fibromyalgiacommon misdiagnoses of fibromyalgiadrugs, alternative remedies, and lifestyle habitsfibromyalgia medicationsis cymbalta right for you? the entire patient information overview for cymbalta (duloxetine hcl)learn more ». the reporting rate of sjs associated with cymbalta use exceeds the general population background incidence rate for this serious skin reaction (1 to 2 cases per million person years). data — in animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/fetal and postnatal development. of treatment — instruct patients that discontinuation of cymbalta may be associated with symptoms such as dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue, and should be advised not to alter their dosing regimen, or stop taking cymbalta without consulting their physician [see warnings and precautions (5. altered anticoagulant effects, including increased bleeding, have been reported when ssris or snris are co-administered with warfarin. for both studies, efficacy analyses were conducted using 13-week data from the combined cymbalta 60 mg and 120 mg once daily treatment groups compared to the placebo group. ssris and snris, including cymbalta have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see warnings and precautions (5. you may ask your healthcare provider or pharmacist for information about cymbalta that is written for healthcare professionals. subsequently, completers of this phase were randomized to double-blind treatment with cymbalta at either 60 mg once daily or 120 mg once daily. after 13 weeks of treatment, patients taking cymbalta 60-120 mg daily had a significantly greater pain reduction compared to placebo. peripheral neuropathic pain — the most commonly observed adverse reactions in cymbalta-treated patients (as defined above) were nausea, somnolence, decreased appetite, constipation, hyperhidrosis, and dry mouth.% (227/1294) of the patients who received cymbalta in 3 to 6 month placebo-controlled trials for fm discontinued treatment due to an adverse reaction, compared with 10. now increased from 30 mg per day of taking duloxetine/cymbalta for 4 months.

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think that cymbalta helps calm down these pain signals by increasing the level of two naturally occurring substances called serotonin and norepinephrine. not take cymbalta if you:Take a monoamine oxidase inhibitor (maoi). cymbalta side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. after 12 weeks of treatment, patients taking cymbalta 60 mg daily had significantly greater pain reduction compared to placebo. if acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, cymbalta should be stopped promptly, and linezolid or intravenous methylene blue can be administered. 2 gives the incidence of treatment-emergent adverse reactions in placebo-controlled trials for approved indications that occurred in 5% or more of patients treated with cymbalta and with an incidence greater than placebo. in this study, cymbalta (n=135) demonstrated superiority over placebo (n=137) from baseline to endpoint as measured by greater improvement in the pediatric anxiety rating scale (pars) for gad severity score (study 6 in table 8). is no specific antidote to cymbalta, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. two hundred and seventy-eight patients who responded to open label treatment (defined as meeting the following criteria at weeks 10 and 12: a hamd-17 total score ≤9, clinical global impressions of severity (cgi-s) ≤2, and not meeting the dsm-iv criteria for mdd) were randomly assigned to continuation of cymbalta at the same dose (n=136) or to placebo (n=142) for 6 months.% female exposed to cymbalta in mdd and gad clinical trials up to 36-weeks in length, in which most patients received 30-120 mg per day. cymbalta and other snris block serotonin and norepinephrine from re-entering cells, and therefore increase the levels of these substances. following adverse reactions have been identified during post approval use of cymbalta. in these trials, as shown in table 5 below, patients treated with cymbalta experienced significantly more sexual dysfunction, as measured by the total score on the asex, than did patients treated with placebo. this medication guide before you start taking cymbalta® and each time you get a refill. cymbalta appears to be associated with concentration-dependent but not clinically meaningful qt shortening. it is not known if cymbalta will harm your unborn baby. data described below reflect exposure to cymbalta in placebo-controlled trials for mdd (n=3779), gad (n=1018), oa (n=503), clbp (n=600), dpnp (n=906), and fm (n=1294). clbp-1 and clbp-3 demonstrated efficacy of cymbalta in the treatment of chronic low back pain. the women were given 40 mg of cymbalta twice daily for 3.% (99/600) of the patients who received cymbalta in 13-week, placebo-controlled trials for clbp discontinued treatment due to an adverse reaction, compared with 6. the developmental and health benefits of human milk feeding should be considered along with the mother's clinical need for cymbalta and any potential adverse effects on the milk-fed child from the drug or from the underlying maternal condition.% (319/3779) of the patients who received cymbalta in placebo-controlled trials for mdd discontinued treatment due to an adverse reaction, compared with 4. treatment with cymbalta 60 mg one or two times a day statistically significantly improved the endpoint mean pain scores from baseline and increased the proportion of patients with at least a 50% reduction in pain scores from baseline. efficacy of cymbalta for the management of neuropathic pain associated with diabetic peripheral neuropathy was established in 2 randomized, 12-week, double-blind, placebo-controlled, fixed-dose studies in adult patients having diabetic peripheral neuropathic pain for at least 6 months. the specific adverse drug reactions observed in adult patients can be expected to be observed in pediatric patients (children and adolescents) [see adverse reactions occurring at an incidence of 2% or more among cymbalta-treated patients in adult placebo-controlled trials]. cymbalta should be discontinued before initiating treatment with the maoi [see dosage and administration (2. in these trials, as shown in table 5 below, patients treated with cymbalta experienced significantly more sexual dysfunction, as measured by the total score on the asex, than did patients treated with placebo. in 2 studies, patients were randomized to cymbalta 60 mg once daily (n=123 and n=128, respectively) or placebo (n=122 and n=139, respectively) for 9 weeks; in the third study, patients were randomized to cymbalta 20 or 40 mg twice daily (n=86 and n=91, respectively) or placebo (n=89) for 8 weeks; in the fourth study, patients were randomized to cymbalta 40 or 60 mg twice daily (n=95 and n=93, respectively) or placebo (n=93) for 8 weeks. reactions occurring at an incidence of 5% or more among cymbalta-treated patients in adult placebo-controlled trials. in the extension phase of these studies, which lasted up to 52 weeks, mean fasting blood glucose increased by 12 mg/dl in the cymbalta group and decreased by 11. > drugs a-z list > cymbalta (duloxetine hcl) side effects drug center. after 13 weeks of treatment, patients taking cymbalta had significantly greater pain reduction. recommended dose of cymbalta for treating depression is 20 or 30 mg twice daily or 60 mg once daily. perform regular monitoring of weight and growth in children and adolescents treated with an snri such as cymbalta [see adverse reactions (6.

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weight and height should be monitored regularly in children and adolescents treated with cymbalta. you should not drive, operate heavy machinery, or do other dangerous activities until you know how cymbalta affects you. clbp-3: four hundred and one patients were randomized to receive fixed doses of cymbalta 60 mg daily or placebo (n=198 on cymbalta, n=203 on placebo), and 303 (76%) completed the study. in fact, doing so increases your chances of side effects., fm, oa, and clbp — table 4 gives the incidence of treatment-emergent adverse events that occurred in 2% or more of patients treated with cymbalta (determined prior to rounding) in the premarketing acute phase of dpnp, fm, oa, and clbp placebo-controlled trials and with an incidence greater than placebo.!I stared cymbalta 30 mg aug 5 & was increased to 60 mg sept 30,2016. have been reports of hepatic failure, sometimes fatal, in patients treated with cymbalta. not take an maoi within 5 days of stopping cymbalta unless directed to do so by your healthcare provider. disposition of cymbalta was studied in 6 lactating women who were at least 12 weeks postpartum and had elected to wean their infants. common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (cymbalta 3.% (139/1018) of the patients who received cymbalta in placebo-controlled trials for gad discontinued treatment due to an adverse reaction, compared with 5. medical help right away if you have any very serious side effects, including: black/bloody stools, vomit that looks like coffee grounds, seizure, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision). caution is advised in using cymbalta in patients with conditions that may slow gastric emptying (e. following abrupt or tapered discontinuation in adult placebo-controlled clinical trials, the following symptoms occurred at 1% or greater and at a significantly higher rate in cymbalta-treated patients compared to those discontinuing from placebo: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. 2 flexible-dose studies involved dose titration with cymbalta doses ranging from 60 mg once daily to 120 mg once daily (n=168 and n=162) compared to placebo (n=159 and n=161) over a 10-week treatment period. for this reason, cymbalta should not be prescribed for patients with substantial alcohol use [see warnings and precautions (5. high bicarbonate, cholesterol, and abnormal (high or low) potassium, were observed more frequently in cymbalta treated patients compared to placebo. treatment with cymbalta and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. is not a complete list of side effects and others may occur. is not a complete list of side effects and others may occur. in extremely acidic conditions, cymbalta, unprotected by the enteric coating, may undergo hydrolysis to form naphthol. common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (cymbalta 3. common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (cymbalta 3. duloxetine is highly bound to plasma protein, administration of cymbalta to a patient taking another drug that is highly protein bound may cause increased free concentrations of the other drug, potentially resulting in adverse reactions. starting cymbalta, tell your healthcare provider if you:Have heart problems or high blood pressure. adverse reactions that occurred at an incidence of less than 2% but were reported by more cymbalta treated patients than placebo treated patients and are associated cymbalta treatment: abnormal dreams (including nightmare), anxiety, flushing (including hot flush), hyperhidrosis, palpitations, pulse increased, and tremor., the benefit of up-titration in non-responders to cymbalta at 60 mg/day was evaluated in a separate study. cyp1a2 and cyp2d6 are responsible for cymbalta metabolism. in some instances of urinary retention associated with cymbalta use, hospitalization and/or catheterization has been needed. are encouraged to report negative side effects of prescription drugs to the fda. subsequently, over the 4- to 6-month uncontrolled extension periods, cymbalta-treated patients on average trended toward recovery to their expected baseline weight percentile based on population data from age- and sex-matched peers. have been on 30 mg of cymbalta since aug 5 & now started 60 mg this weekend that just passed. common side effects may include:dry mouth;drowsiness;tired feeling;mild nausea or loss of appetite; orconstipation. studies compared cymbalta 60 mg once daily or 60 mg twice daily with placebo.

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Side effects for cymbalta 30 mg

metabolized by cyp2d6 — co-administration of cymbalta with drugs that are extensively metabolized by cyp2d6 and that have a narrow therapeutic index, including certain antidepressants (tricyclic antidepressants [tcas], such as nortriptyline, amitriptyline, and imipramine), phenothiazines and type 1c antiarrhythmics (e. Learn the side effects, benefits, and what you should think about when considering the use of this drug. data below do not include results of the trial examining the efficacy of cymbalta in patients ≥ 65 years old for the treatment of generalized anxiety disorder; however, the adverse reactions observed in this geriatric sample were generally similar to adverse reactions in the overall adult population. prescriptions for cymbalta should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose. adverse reactions observed during the premarketing and postmarketing clinical trial evaluation of cymbalta in adults. cymbalta should not be used in combination with monoamine oxidase inhibitors (maoi) (for example, phenelzine [nardil]). and cymbalta consumer information is supplied by first databank, inc. cymbalta belongs to a class of medicines known as snris (or serotonin-norepinephrine reuptake inhibitors). common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (cymbalta 3. pupillary dilation that occurs following use of many antidepressant drugs including cymbalta may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.​the development of a potentially life-threatening serotonin syndrome has been reported with snris and ssris, including cymbalta, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and st. you may report side effects to fda at 1-800-fda-1088. most common side effects of cymbalta include:Common possible side effects in children and adolescents who take cymbalta include:Side effects in adults may also occur in children and adolescents who take cymbalta.​if concomitant use of cymbalta with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and st. caution is advised in using cymbalta in patients with conditions that may slow gastric emptying (e. females did not experience more sexual dysfunction on cymbalta than on placebo as measured by asex total score. who take cymbalta close in time to an maoi may have a serious problem called serotonin syndrome (see “what are the possible side effects of cymbalta? do not give cymbalta to other people, even if they have the same symptoms that you have. you may report side effects to health canada at 1-866-234-2345. syncope and orthostatic hypotension tend to occur within the first week of therapy but can occur at any time during cymbalta treatment, particularly after dose increases. is a collection of user reviews for the medication cymbalta sorted by most helpful. there is no information on the effect that alterations in gastric motility may have on the stability of cymbalta's enteric coating. adult placebo-controlled clinical trials across indications from baseline to endpoint, cymbalta treatment was associated with mean increases of 0. the amount of cymbalta in breast milk was approximately 7 mcg/day while on that dose; the estimated daily infant dose was approximately 2 mcg/kg/day. cymbalta demonstrated superiority over placebo as measured by greater improvement in the pediatric anxiety rating scale (pars) for gad severity score [see clinical studies (14. after 13 weeks of treatment, patients taking cymbalta did not show a significantly greater pain reduction. 20 mgcapsule, green, imprinted with 20 mg, lilly 3235cymbalta 30 mgcapsule, blue/white, imprinted with lilly 3240, 30 mgcymbalta 60 mgcapsule, blue/yellow, imprinted with lilly 3237, 60 mgwhat are the possible side effects of duloxetine (cymbalta)? talk to your healthcare provider about the side effects of the medicine prescribed for you or your family member. placebo-controlled clinical trials across approved indications for change from baseline to endpoint, cymbalta treatment was associated with mean increases of 0. — for most patients, initiate cymbalta 60 mg once daily. and snris, including cymbalta, may increase the risk of bleeding events.'ve been on cymbalta 60mg for many years and have recently decided to wean off and try a more natural approach to pain management. as elderly patients tend to have a higher prevalence of risk factors for falls such as medications, medical comorbidities and gait disturbances, the impact of increasing age by itself on falls during treatment with cymbalta is unclear. data described below reflect exposure to cymbalta in pediatric, 10-week, placebo-controlled trials for mdd (n=341) and gad (n=135).

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placebo-controlled clinical trials across approved indications for change from baseline to endpoint, cymbalta treatment was associated with mean increases of 0. cymbalta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (cymbalta 2. talk to your healthcare provider about the benefits and risks of treating depression or other conditions with cymbalta during pregnancy. the safety and effectiveness of cymbalta have not been established in pediatric patients less than 18 years of age with other indications. that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (cymbalta 2. studies compared cymbalta 60 mg once daily or 120 mg daily (given in divided doses in fm-1 and as a single daily dose in fm-2) with placebo. high bicarbonate, cholesterol, and abnormal (high or low) potassium, were observed more frequently in cymbalta treated patients compared to placebo. of cymbalta concomitantly with heavy alcohol intake may be associated with severe liver injury. hypotension, falls and syncope have been reported with therapeutic doses of cymbalta. have recently been prescribed 30 milligrams cymbalta per day to start. common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (cymbalta 3. oxidase inhibitors (maois) — the use of maois intended to treat psychiatric disorders with cymbalta or within 5 days of stopping treatment with cymbalta is contraindicated because of an increased risk of serotonin syndrome. common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (cymbalta 2., ​my first day today of 30mg cymbalta, not feeling well, dizzy all day, spaceed out, disconnected,( i was on prozac 10mg before but too nervous) it go away ? adverse reactions observed during the premarketing and postmarketing clinical trial evaluation of cymbalta in adults. — the data described below reflect exposure to cymbalta in placebo-controlled trials for mdd (n=3779), gad (n=1018), oa (n=503), clbp (n=600), dpnp (n=906), and fm (n=1294). instruct patients to talk to their healthcare provider if they develop itching, right upper belly pain, dark urine, or yellow skin/eyes while taking cymbalta, which may be signs of liver problems. patients treated with cymbalta (n=151) demonstrated significantly greater improvement compared with placebo (n=140) on mean change from baseline to endpoint as measured by the hamilton anxiety rating scale total score (study 5 in table 8). effect of cymbalta 160 mg and 200 mg administered twice daily to steady state was evaluated in a randomized, double-blinded, two-way crossover study in 117 healthy female subjects. the use of cymbalta within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2. may cause serious side effects, including: see “what is the most important information i should know about cymbalta? 6 provides the incidence of treatment-emergent adverse reactions in mdd and gad pediatric placebo-controlled trials that occurred in greater than 2% of patients treated with cymbalta and with an incidence greater than placebo. plasma tca concentrations may need to be monitored and the dose of the tca may need to be reduced if a tca is co-administered with cymbalta. trials for all approved indications — the most commonly observed adverse reactions in cymbalta-treated patients (incidence of at least 5% and at least twice the incidence in placebo patients) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis. after the first week, the dose of cymbalta was increased to 60 mg once daily. consideration should be given to dose reduction or discontinuation of cymbalta in patients who experience symptomatic orthostatic hypotension, falls and/or syncope during cymbalta therapy. cymbalta and ethanol were administered several hours apart so that peak concentrations of each would coincide, cymbalta did not increase the impairment of mental and motor skills caused by alcohol. cymbalta and all medicines out of the reach of children. do not take two doses of cymbalta at the same time. inhibitors — because cyp2d6 is involved in cymbalta metabolism, concomitant use of cymbalta with potent inhibitors of cyp2d6 would be expected to, and does, result in higher concentrations (on average of 60%) of cymbalta [see drug interactions (7. a total of 354 patients (234 cymbalta, 120 placebo) were enrolled in fm-1 and a total of 520 patients (376 cymbalta, 144 placebo) were enrolled in fm-2 (5% male, 95% female). reactions occurring at an incidence of 2% or more among cymbalta-treated patients in adult placebo-controlled trials.

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clbp-1: two hundred thirty-six adult patients (n=115 on cymbalta, n=121 on placebo) enrolled and 182 (77%) completed 13-week treatment phase. canada - call your doctor for medical advice about side effects. beats per minute in cymbalta - treated patients, decrease of 0. diabetes (cymbalta treatment makes it harder for some people with diabetes to control their blood sugar). least 14 days should elapse between discontinuation of an maoi intended to treat psychiatric disorders and initiation of therapy with cymbalta. at steady state, the concentration of cymbalta in breast milk was approximately 25% that of maternal plasma. it is possible that cymbalta and alcohol may interact to cause liver injury or that cymbalta may aggravate pre-existing liver disease, cymbalta should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. not start cymbalta if you stopped taking an maoi in the last 14 days unless directed to do so by your healthcare provider. reactions occurring at an incidence of 5% or more among cymbalta-treated patients in adult placebo-controlled trials. the therapy prescribed — while patients may notice improvement with cymbalta therapy in 1 to 4 weeks, advise patients to continue therapy as directed. efficacy of cymbalta in chronic pain due to osteoarthritis was assessed in 2 double-blind, placebo-controlled, randomized clinical trials of 13-weeks duration (study oa-1 and study oa-2). — initiate cymbalta at a dose of 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg. reactions reported since market introduction that were temporally related to cymbalta therapy and not mentioned elsewhere in labeling include: acute pancreatitis, anaphylactic reaction, aggression and anger (particularly early in treatment or after treatment discontinuation), angioneurotic edema, angle-closure glaucoma, colitis (microscopic or unspecified), cutaneous vasculitis (sometimes associated with systemic involvement), extrapyramidal disorder, galactorrhea, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity, hypertensive crisis, muscle spasm, rash, restless legs syndrome, seizures upon treatment discontinuation, supraventricular arrhythmia, tinnitus (upon treatment discontinuation), trismus, and urticaria. the agency approved cymbalta for the management of fibromyalgia in adults in june 2008. cymbalta should also not be started in a patient who is being treated with maois such as linezolid or intravenous methylene blue. — advise patients that hyponatremia has been reported as a result of treatment with snris and ssris, including cymbalta.. cymbalta and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. are not exactly certain how cymbalta helps make patients with fibromyalgia feel better; fibromyalgia itself is poorly understood.. discontinuation symptoms: do not stop cymbalta without first talking to your healthcare provider. and adolescents (7 to 17 years of age) — initiate cymbalta at a dose of 30 mg once daily for 2 weeks before considering an increase to 60 mg. if symptoms of urinary hesitation develop during treatment with cymbalta, consideration should be given to the possibility that they might be drug-related. oa-2: two hundred thirty-one patients (n=111 on cymbalta, n=120 on placebo) enrolled and 173 (75%) completed the study. these are not all the possible side effects of cymbalta. after 13 weeks of treatment, none of the three cymbalta doses showed a statistically significant difference in pain reduction compared to placebo.© cymbalta patient information is supplied by cerner multum, inc. hypotension, falls and syncope — advise patients of the risk of orthostatic hypotension, falls and syncope, especially during the period of initial use and subsequent dose escalation, and in association with the use of concomitant drugs that might potentiate the orthostatic effect of cymbalta [see warnings and precautions (5. most commonly observed adverse reactions in cymbalta-treated patients (as defined above) were nausea, dry mouth, constipation, somnolence, decreased appetite, hyperhidrosis, and agitation. concomitant use of cymbalta with maois intended to treat psychiatric disorders is contraindicated. however, co-administration of cymbalta with aluminum- and magnesium-containing antacids (51 meq) or cymbalta with famotidine, had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose. it should be noted that cymbalta is not approved for use in treating bipolar depression. four hundred and twenty-nine patients who responded to open-label treatment (defined as meeting the following criteria at weeks 24 and 26: a decrease from baseline ham-a total score by at least 50% to a score no higher than 11, and a clinical global impressions of improvement [cgi-improvement] score of 1 or 2) were randomly assigned to continuation of cymbalta at the same dose (n=216) or to placebo (n=213) and were observed for relapse. in the 12-week acute treatment phase of these studies, cymbalta was associated with a small increase in mean fasting blood glucose as compared to placebo.% (79/503) of the patients who received cymbalta in 13-week, placebo-controlled trials for chronic pain due to oa discontinued treatment due to an adverse reaction, compared with 7. an analysis of data from all placebo-controlled-trials, patients treated with cymbalta reported a higher rate of falls compared to patients treated with placebo.

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females did not experience more sexual dysfunction on cymbalta than on placebo as measured by asex total score. conversely, at least 5 days should be allowed after stopping cymbalta before starting an maoi intended to treat psychiatric disorders [see contraindications (4)]. the side effects are a big concern for my with her drowsiness and lack of coordination but she has lost her appetite which seems to be.% female exposed to cymbalta in mdd and gad clinical trials up to 36-weeks in length, in which most patients received 30-120 mg per day. an analysis of patients from all placebo-controlled trials, patients treated with cymbalta reported a higher rate of falls compared to patients treated with placebo. similar effects would be expected with other potent cyp2d6 inhibitors (e. data below do not include results of the trial examining the efficacy of cymbalta in patients ≥ 65 years old for the treatment of generalized anxiety disorder; however, the adverse reactions observed in this geriatric sample were generally similar to adverse reactions in the overall adult population. ,can i drink a slip of beer while on cymbalta ? all 4 studies, cymbalta demonstrated superiority over placebo as measured by improvement in the 17-item hamilton depression rating scale (hamd-17) total score (studies 1-4 in table 7).. severe skin reactions: cymbalta may cause serious skin reactions that may require stopping its use. fm-2 additionally compared cymbalta 20 mg with placebo during the initial three months of a six-month study. not take cymbalta with any other medicine that contain duloxetine. mdd and gad trials — table 3 gives the incidence of treatment-emergent adverse reactions in mdd and gad placebo-controlled trials for approved indications that occurred in 2% or more of patients treated with cymbalta and with an incidence greater than placebo. those patients who were considered non-responders, where response was defined as at least a 30% reduction in pain score from baseline at the end of the 8-week treatment, were no more likely to meet response criteria at the end of 60 weeks of treatment if blindly titrated to cymbalta 120 mg as compared to those who were blindly continued on cymbalta 60 mg. the most commonly reported symptoms following discontinuation of cymbalta in pediatric clinical trials have included headache, dizziness, insomnia, and abdominal pain [see warnings and precautions (5.. in extremely acidic conditions, cymbalta, unprotected by the enteric coating, may undergo hydrolysis to form naphthol. increased plasma concentration of cymbalta, and especially of its metabolites, occur in patients with end-stage renal disease (requiring dialysis) [see dosage and administration (2. you may report side effects to fda at 1-800-fda-1088. after a single 20 mg dose of cymbalta, 6 cirrhotic patients with moderate liver impairment (child-pugh class b) had a mean plasma duloxetine clearance about 15% that of age- and gender-matched healthy subjects, with a 5-fold increase in mean exposure (auc). acting drugs — given the primary cns effects of cymbalta, it should be used with caution when it is taken in combination with or substituted for other centrally acting drugs, including those with a similar mechanism of action [see warnings and precautions (5. should be cautioned about the risk of bleeding associated with the concomitant use of cymbalta and nsaids, aspirin, or other drugs that affect coagulation.  they have switched me over to cymbalta 30mg and been on it for 20 days. may occur as a result of treatment with ssris and snris, including cymbalta. following adverse reactions have been identified during post approval use of cymbalta. because of the risk of serious ventricular arrhythmias and sudden death potentially associated with elevated plasma levels of thioridazine, cymbalta and thioridazine should not be co-administered [see drug interactions (7. subsequently, over the 4-to 6-month uncontrolled extension periods, cymbalta-treated patients on average trended toward recovery to their expected baseline weight percentile based on population data from age-and sex-matched peers. skin reactions — caution patients that cymbalta may cause serious skin reactions.., discontinuation occurring in at least 1% of the cymbalta-treated patients and at a rate of at least twice that of placebo). efficacy of cymbalta in the treatment of pediatric patients 7 to 17 years of age with generalized anxiety disorder (gad) was established in 1 flexible-dose randomized, double-blind, placebo-controlled trial in pediatric outpatients with gad (based on dsm-iv criteria). page:what should i discuss with my healthcare provider before taking duloxetine (cymbalta)? most commonly observed adverse reactions in cymbalta-treated patients (as defined above) were nausea, somnolence, decreased appetite, constipation, hyperhidrosis, and dry mouth.% (227/1294) of the patients who received cymbalta in 3 to 6 month placebo-controlled trials for fm discontinued treatment due to an adverse reaction, compared with 10.. family history of suicide, bipolar disorder, and depression) prior to initiating treatment with cymbalta. on medication guide — inform patients, their families, and their caregivers about the benefits and risks associated with treatment with cymbalta and counsel them in its appropriate use.

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at least 5 days should be allowed after stopping cymbalta before starting an maoi. cymbalta and some medicines may interact with each other, may not work as well, or may cause serious side effects. patients were permitted up to 4 g of acetaminophen per day as needed for pain, in addition to cymbalta. another study, 887 patients meeting dsm-iv-tr criteria for gad received cymbalta 60 mg to 120 mg once daily during an initial 26-week open-label treatment phase. the fda previously approved cymbalta for the treatment of depression, generalized anxiety disorder, and diabetic peripheral neuropathic pain. the presence of cymbalta metabolites in breast milk was not examined.% (139/1018) of the patients who received cymbalta in placebo-controlled trials for gad discontinued treatment due to an adverse reaction, compared with 5. have recently been prescribed 30 milligrams cymbalta per day to start. should be monitored for these symptoms when discontinuing treatment with cymbalta. clbp-2: four hundred and four patients were randomized to receive fixed doses of cymbalta daily or a matching placebo (n=59 on cymbalta 20 mg, n=116 on cymbalta 60 mg, n=112 on cymbalta 120 mg, n=117 on placebo) and 267 (66%) completed the entire 13-week study. as with these other agents, cymbalta should be used cautiously in patients with a history of mania. the cymbalta clinical trials database, three cymbalta-treated patients had liver injury as manifested by alt and total bilirubin elevations, with evidence of obstruction. patients assigned to cymbalta started treatment in both studies at a dose of 30 mg once daily for one week. you may report side effects to fda at 1-800-fda-1088. pain due to osteoarthritis — the most commonly observed adverse reactions in cymbalta-treated patients (as defined above) were nausea, fatigue, constipation, dry mouth, insomnia, somnolence, and dizziness. if any of these effects persist or worsen, tell your doctor promptly. although in controlled studies cymbalta has not been shown to impair psychomotor performance, cognitive function, or memory, it may be associated with sedation and dizziness. the 2,418 patients in premarketing clinical studies of cymbalta for mdd, 5. do not take two doses of cymbalta at the same time. if a dose of cymbalta is missed, take the missed dose as soon as it is remembered. mellaril together with cymbalta can cause serious heart rhythm problems or sudden death. skin reactions, including erythema multiforme and stevens-johnson syndrome (sjs), can occur with cymbalta. risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with cymbalta is unclear. and adolescents — the data described below reflect exposure to cymbalta in pediatric, 10-week, placebo-controlled trials for mdd (n=341) and gad (n=135). use — safety and efficacy of cymbalta in patients 7 to 17 years of age have been established for the treatment of gad. the fixed-dose study evaluated cymbalta doses of 60 mg once daily (n=168) and 120 mg once daily (n=170) compared to placebo (n=175) over a 9-week treatment period. therapy with cymbalta may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see warnings and precautions (5. because adverse sexual reactions are presumed to be voluntarily underreported, the arizona sexual experience scale (asex), a validated measure designed to identify sexual side effects, was used prospectively in 4 mdd placebo-controlled trials.% (117/906) of the patients who received cymbalta in placebo-controlled trials for dpnp discontinued treatment due to an adverse reaction, compared with 5. another study, 533 patients meeting dsm-iv criteria for mdd received cymbalta 60 mg once daily during an initial 12-week open-label treatment phase. most commonly observed adverse reactions in cymbalta-treated patients (incidence of at least 5% and at least twice the incidence in placebo patients) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis. all i'm currently withdrawing from duloxetine (cymbalta) as i've been on it a few months to treat panic attacks and anxiety but it's not been helpful, hence the withdrawal. your blood pressure when standing and cause dizziness or fainting, mostly when first starting cymbalta or when increasing the dose. 2 gives the incidence of treatment-emergent adverse reactions in placebo-controlled trials for approved indications that occurred in 5% or more of patients treated with cymbalta and with an incidence greater than placebo.

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switching from another antidepressant to cymbalta your healthcare provider may want to lower the dose of the initial antidepressant first to potentially avoid side effects. cymbalta at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). some cases, a patient already receiving cymbalta therapy may require urgent treatment with linezolid or intravenous methylene blue. adverse reactions that occurred at an incidence of less than 2% but were reported by more cymbalta treated patients than placebo treated patients and are associated cymbalta treatment: abnormal dreams (including nightmare), anxiety, flushing (including hot flush), hyperhidrosis, palpitations, pulse increased, and tremor. because adverse sexual reactions are presumed to be voluntarily underreported, the arizona sexual experience scale (asex), a validated measure designed to identify sexual side effects, was used prospectively in 4 mdd placebo-controlled trials. the effectiveness of cymbalta in hospitalized patients with major depressive disorder has not been studied. you take too much cymbalta, call your healthcare provider or poison control center at 1-800-222-1222 right away, or get emergency treatment. cymbalta should be prescribed with care in patients with a history of a seizure disorder. most commonly observed adverse reactions in cymbalta-treated patients (as defined above) were nausea, dry mouth, insomnia, somnolence, constipation, dizziness, and fatigue. use of cymbalta with heavy alcohol intake may be associated with severe liver injury [see warnings and precautions (5., ​my first day today of 30mg cymbalta, not feeling well, dizzy all day, spaceed out, disconnected,( i was on prozac 10mg before but too nervous) it go away ? however, in oa-2, all patients, regardless of their response to treatment after 7 weeks, were re-randomized to either continue receiving cymbalta 60 mg once daily or have their dose increased to 120 mg once daily for the remainder of the study. all 3 studies, cymbalta demonstrated superiority over placebo as measured by greater improvement in the hamilton anxiety scale (ham-a) total score (studies 1-3 in table 8) and by the sheehan disability scale (sds) global functional impairment score. if symptoms of urinary hesitation develop during treatment with cymbalta, consideration should be given to the possibility that they might be drug-related. efficacy of cymbalta in chronic low back pain (clbp) was assessed in two double-blind, placebo-controlled, randomized clinical trials of 13-weeks duration (study clbp-1 and study clbp-2), and one of 12-weeks duration (clbp-3). on blood pressure — caution patients that cymbalta may cause an increase in blood pressure [see warnings and precautions (5. you miss a dose of cymbalta, take the missed dose as soon as you remember. experience with cymbalta in patients with concomitant systemic illnesses is limited. control in patients with diabetes — as observed in dpnp trials, cymbalta treatment worsens glycemic control in some patients with diabetes. effect of cymbalta 160 mg and 200 mg administered twice daily to steady state was evaluated in a randomized, double-blinded, two-way crossover study in 117 healthy female subjects.%) was greater in the cymbalta group than in the placebo group (14% and 6%, respectively). oa-1: two hundred fifty-six patients (n=128 on cymbalta, n=128 on placebo) enrolled and 204 (80%) completed the study. efficacy of cymbalta as a treatment for depression was established in 4 randomized, double-blind, placebo-controlled, fixed-dose studies in adult outpatients (18 to 83 years) meeting dsm-iv criteria for major depression.%) was greater in the cymbalta group than in the placebo group (14% and 6%, respectively). the entire detailed patient monograph for cymbalta (duloxetine hcl)learn more ». talk to your healthcare provider about the best way to feed your baby while taking cymbalta. syndrome — caution patients about the risk of serotonin syndrome with the concomitant use of cymbalta and other serotonergic agents including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and st. have trigeminal neuropathy plus tmj i get locked jaw all the time my pain is in my left side in my top teeth hurts pretty sometimes pretty bad an forehead pain i have had mine for over a year im on medication but there are side effects but im managing. discontinuation of cymbalta should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. exercise caution when cymbalta is administered to a nursing woman. instruct patients, their families, and their caregivers to read the medication guide before starting cymbalta and each time their prescription is renewed, and assist them in understanding its contents. am currently on cymbalta 60 mg my doctor just up my milligrams to 120 i was reading that 120 was too much to be taking is this correct and have you had any side effects of trying to get off of this medicine. efficacy of cymbalta for the management of fibromyalgia was established in two randomized, double-blind, placebo-controlled, fixed-dose studies in adult patients meeting the american college of rheumatology criteria for fibromyalgia (a history of widespread pain for 3 months, and pain present at 11 or more of the 18 specific tender point sites). reactions reported since market introduction that were temporally related to cymbalta therapy and not mentioned elsewhere in labeling include: acute pancreatitis, anaphylactic reaction, aggression and anger (particularly early in treatment or after treatment discontinuation), angioneurotic edema, angle-closure glaucoma, colitis (microscopic or unspecified), cutaneous vasculitis (sometimes associated with systemic involvement), extrapyramidal disorder, galactorrhea, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity, hypertensive crisis, muscle spasm, rash, restless legs syndrome, seizures upon treatment discontinuation, supraventricular arrhythmia, tinnitus (upon treatment discontinuation), trismus, and urticaria.

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