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Commonly reported side effects of duloxetine include: asthenia, constipation, diarrhea, dizziness, drowsiness, fatigue, hypersomnia, insomnia, nausea, sedated state, headache, and xerostomia. Other side effects include: agitation, erectile dysfunction, nervousness, psychomotor agitation, tension, vomiting, abdominal pain, anorexia, decreased appetite, decreased libido, hyperhidrosis, loss of libido, and restlessness. See below for a comprehensive list of adverse effects.For the Consumer
Applies to duloxetine: oral capsule delayed release
Oral route (Capsule, Delayed Release)
Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder. Short-term studies did not show an increase in the risk of suicidality with antidepressants in adults beyond age 24, and there was a reduction in risk with antidepressants in adults aged 65 or older. Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers to closely observe the patient and communicate with the prescriber.
Along with its needed effects, duloxetine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking duloxetine:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking duloxetine:
Symptoms of overdose
Some side effects of duloxetine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
For Healthcare Professionals
Applies to duloxetine: oral delayed release capsuleGeneral
The most commonly reported side effects reported in placebo-controlled clinical trials included nausea, dry mouth, somnolence, constipation, decreased appetite, hyperhidrosis, agitation, fatigue, insomnia, dizziness
The most commonly reported side effects reported in placebo-controlled clinical trials as a reason for treatment discontinuation and considered to be drug-related included nausea, dizziness, somnolence, headache, and fatigue.Gastrointestinal
Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between the use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding.
Very common (10% or more): Constipation, diarrhea, dry mouth, nausea
Common (1% to 10%): Abdominal pain, dyspepsia, flatulence, vomiting
Uncommon (0.1% to 1%): Dysphagia, eructation, gastritis, gastroenteritis, gastrointestinal hemorrhage, halitosis, hematochezia, stomatitis
Rare (less than 0.1%): Gastric ulcer
Postmarketing reports: Gastrointestinal bleeding, pancreatitis, colitis (microscopic or unspecified)Nervous system
Very common (10% or more): Dizziness, headache, somnolence
Common (1% to 10%): Dysgeusia, lethargy, paraesthesia/hypoesthesia, tremor
Uncommon (0.1% to 1%): Convulsions, disturbance in attention, dyskinesia, extrapyramidal symptoms, myoclonus, psychomotor restlessness, restless legs syndrome, trismus, syncope
Rare (less than 0.1%): Akathisia, dysarthria, gait disturbance
Postmarketing reports: Intracerebral bleeding, seizures upon treatment discontinuation, serotonin syndrome, extrapyramidal disorder
Potentially life-threatening serotonin syndrome has been reported with SSRIs and SNRIs, including duloxetine as monotherapy, but particularly with concomitant use of other serotonergic drugs and drugs that impair the metabolism of serotonin.Psychiatric
Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. An increased risk of suicidal thinking and behavior in children, adolescents, and young adults (aged 18 to 24 years) with major depressive disorder (MDD) and other psychiatric disorders has been reported with short-term use of antidepressant drugs.
Adult and pediatric patients receiving antidepressants for MDD, as well as for psychiatric and nonpsychiatric indications, have reported symptoms that may be precursors to emerging suicidality, including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Causality has not been established.
Aggression and anger have been reported particularly early in treatment or after treatment discontinuation.
Very common (10% or more): Insomnia
Common (1% to 10%): Abnormal dreams, agitation, anxiety, sleep disorder
Uncommon (0.1% to 1%): Apathy, bruxism, disorientation/confusional state, irritability, mood swings, nervousness, poor quality sleep, suicide attempt
Rare (less than 0.1%): Aggression and anger, completed suicide, hallucinations, mania, suicidal behavior and ideationMetabolic
Common (1% to 10%): Decreased appetite, weight increase/decrease
Uncommon (0.1% to 1%): Dehydration, hyperlipidemia, hyponatremia, increased blood cholesterol, increased blood creatine phosphokinase
Rare (less than 0.1%): Dyslipidemia, increased blood potassium
Frequency not reported: Abnormal potassium levels, increased bicarbonate
Postmarketing reports: Hyperglycemia
Although infrequent, several cases of duloxetine induced hyponatremia have been reported. In one case report, duloxetine induced hyponatremia was confirmed after inadvertent rechallenge. It has been suggested that there is a dose-related effect in the development of hyponatremia with duloxetine. Numerous cases of hyponatremia have been reported following treatment with an SSRI. Risk factors include advanced age, female gender, concomitant use of diuretics, low body weight, and lower baseline serum sodium levels.
Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment (e.g., water restriction, dietary sodium). The proposed mechanism for the development of hyponatremia involves the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) via release of antidiuretic hormone.Other
Falls were reported more commonly in patients 65 years of age or older.
Very common (10% or more): Fatigue
Common (1% to 10%): Asthenia, chills/rigors, pyrexia, vertigo
Uncommon (0.1% to 1%): Ear pain, falls, feeling abnormal, feeling hot and/or cold, malaise, thirst, tinnitusCardiovascular
Orthostatic hypotension and syncope tend to occur within the first week of therapy; however, they may occur at any time during treatment, particularly after dose increases. The risk of blood pressure decreases may be greater when duloxetine is given concomitantly with drugs that may induce orthostatic hypotension, such as antihypertensives, with potent CYP450 1A2 inhibitors, or with duloxetine doses above 60 mg per day.
Common (1% to 10%): Flushing, hot flush, hypertension, increased blood pressure, palpitations
Uncommon (0.1% to 1%): Chest pain, myocardial infarction, orthostatic hypotension, peripheral coldness, tachycardia
Rare (less than 0.1%): Hypertensive crisis, supraventricular arrhythmia (mainly atrial fibrillation)
Postmarketing reports: Hematomas, ventricular arrhythmiasDermatologic
The reporting rate of Stevens-Johnson syndrome associated with duloxetine exceeds the general population background incidence rate (1 to 2 cases per million person years).
Common (1% to 10%): Pruritus, hyperhidrosis
Uncommon (0.1% to 1%): Cold sweat, contact dermatitis, erythema, increased tendency to bruise, night sweats, photosensitivity reaction, urticaria
Rare (less than 0.1%): Angioneurotic edema, ecchymosis, Stevens-Johnson syndrome
Postmarketing reports: Erythema multiforme, petechiae, cutaneous vasculitis (sometimes with systemic involvement)Endocrine
Uncommon (0.1% to 1%): Hypothyroidism, syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
Postmarketing reports: HyperprolactinemiaGenitourinary
The Arizona sexual experience scale, used to identify sexual side effects, was used prospectively in 4 major depressive disorder placebo-controlled trials showed that male patients treated with duloxetine experienced significantly more sexual dysfunction than patients treated with placebo.
Common (1% to 10%): Abnormal orgasm/anorgasmia, decreased libido, delayed ejaculation, ejaculation disorder, erectile dysfunction, urinary frequency
Uncommon (0.1% to 1%): Abnormal urine odor, dysuria, gynecological hemorrhage, menopausal symptoms, micturition urgency, nocturia, pollakiuria, polyuria, sexual dysfunction, testicular pain, urinary hesitation
Rare (less than 0.1%): Decreased urine flow, galactorrhea, menstrual disorder, urinary retentionHematologic
Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may increase the risk of bleeding events associated with duloxetine.
Postmarketing reports: Life-threatening hemorrhage, blood dyscrasiasHepatic
Cases of liver failure, including fatalities, have been reported. The majority of cases were reported in patients with past or current risk factors for liver injury, including alcohol abuse, hepatitis, or exposure to drugs with known adverse effects on the liver.
Uncommon (0.1% to 1%): Acute liver injury, elevated liver enzymes (ALT, AST, GGT, alkaline phosphatase), hepatitis, increased blood bilirubin
Rare (less than 0.1%): Hepatic failure, jaundiceHypersensitivity
Postmarketing reports: Anaphylactic reaction, hypersensitivityImmunologic
Common (1% to 10%): InfluenzaMusculoskeletal
Common (1% to 10%): Back pain, muscle spasms, musculoskeletal pain (including myalgia, neck pain)
Uncommon (0.1% to 1%): Muscle tightness (including musculoskeletal stiffness), muscle twitching
Postmarketing reports: RhabdomyolysisOcular
Pupillary dilation that occurs following the use of many antidepressant drugs may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Diplopia, dry eye, mydriasis, visual impairment
Rare (less than 0.1%): GlaucomaRenal
Postmarketing reports: Renal impairmentRespiratory
Common (1% to 10%): Cough, nasopharyngitis, oropharyngeal pain, pharyngolaryngeal pain, upper respiratory tract infection, yawning
Uncommon (0.1% to 1%): Laryngitis, throat tightness
Rare (less than 0.1%): Epistaxis
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