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Duloxetine Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 21, 2021.

Summary

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 delayed-release capsules

Warning

    Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.1 8 9 Duloxetine is not approved for use in pediatric patients.1 (See Pediatric Use under Cautions.)

  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.1 8 9

  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.1 8 9 10

  • Appropriately monitor and closely observe all patients who are started on duloxetine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.1 8 9 10 (See Worsening of Depression and Suicidality Risk under Cautions.)

Side effects include:

Nausea, dry mouth, constipation, diarrhea, decreased appetite, vomiting, fatigue, somnolence, insomnia, dizziness, asthenia, agitation, hyperhidrosis or increased sweating, and decreased sexual function (e.g., decreased libido, delayed ejaculation, erectile dysfunction).

For Healthcare Professionals

Applies to duloxetine: oral delayed release capsule

General

The most commonly reported side effects included nausea, somnolence, headache, and dizziness.[Ref]

Gastrointestinal

Abdominal pain more commonly occurred in pediatric patients.

Constipation occurred most frequently in patients given 60 mg orally 2 times a day (N=225); the side effect occurred in 11% of patients given 60 mg orally once a day, and in 5% of patients given 20 mg orally once a day.

Diarrhea occurred most frequently in patients given 20 mg orally once a day (N=115); the side effect occurred in 7% of patients given 60 mg orally 2 times a day, and in 11% of patients given 60 mg orally once a day.

Dry mouth occurred most frequently in patients in patients with generalized anxiety disorder (GAD) or major depressive disorder (MDD) compared to placebo (N=2995).

Nausea occurred most frequently in patients given 60 mg orally 2 times a day (N=225); the side effect occurred in 22% of patients given 60 mg orally once a day, and in 14% of patients given 20 mg orally once a day.

Vomiting occurred more frequently in patients 13 to 17 years of age with fibromyalgia.[Ref]

Very common (10% or more): Nausea (up to 30%), constipation (up to 15%), dry mouth (up to 15%), vomiting (up to 15%), abdominal pain (up to 13%), diarrhea (up to 13%)

Common (1% to 10%): Dyspepsia, flatulence, loose stools, oral paresthesia, stomach discomfort, viral gastroenteritis/gastroenteritis

Uncommon (0.1% to 1%): Dysphagia, eructation, gastritis, gastrointestinal bleeding/hemorrhage, halitosis, stomatitis

Rare (0.01% to 0.1%): Gastric ulcer, hematochezia, microscopic colitis

Frequency not reported: Abdominal discomfort, abdominal tenderness, gastrointestinal pain, lower abdominal pain, upper abdominal pain

Postmarketing reports: Pancreatitis, unspecified colitis[Ref]

Nervous system

Very common (10% or more): Somnolence (up to 21%), headache (up to 18%), dizziness (up to 17%)

Common (1% to 10%): Dysgeusia, facial hypoesthesia, hypoesthesia, lethargy, paresthesia, psychomotor agitation, tremor, vertigo

Uncommon (0.1% to 1%): Akathisia, attention disturbance, dyskinesia, gait disturbance, myoclonus, poor quality sleep, restless legs syndrome, syncope

Rare (0.01% to 0.1%): Convulsion, dysarthria, extrapyramidal disorder, psychomotor restlessness, serotonin syndrome

Very rare (less than 0.01%): Electric shock-like sensation, seizures

Frequency not reported: Hypersomnia, psychomotor hyperactivity, sedation, sensory disturbances

Postmarketing reports: Intracerebral bleeding[Ref]

Dizziness occurred most frequently in patients given 60 mg orally 2 times a day (N=225); the side effect occurred in 14% of patients given 60 mg orally once a day, and in 6% of patients given 20 mg orally once a day.

Headache more commonly occurred in pediatric patients.

Convulsion and seizures were reported during treatment discontinuation.

Somnolence occurred most frequently in patients given 60 mg orally 2 times a day (N=225); the side effect occurred in 15% of patients given 60 mg orally once a day, and in 7% of patients given 20 mg orally once a day.

Syncope was reported, especially during treatment initiation.[Ref]

Metabolic

Very common (10% or more): Decreased weight (up to 16%), decreased appetite (up to 16%)

Common (1% to 10%): Anorexia, increased weight

Uncommon (0.1% to 1%): Blood potassium increased, dehydration, hyperglycemia, hyperlipidemia, increased blood cholesterol, thirst

Rare (0.01% to 0.1%): Dyslipidemia, hyponatremia[Ref]

Decreased appetite occurred more frequently in patients 13 to 17 years of age with fibromyalgia.

Decreased weight of at least 3.5% occurred more frequently in patients 7 to 17 years of age with GAD and/or MDD.

Hyperglycemia was more commonly reported in patients with diabetes.[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 14%)

Common (1% to 10%): Cough, oropharyngeal pain, pharyngolaryngeal pain, upper respiratory tract infection, yawning

Uncommon (0.1% to 1%): Epistaxis, throat tightness

Rare (0.01% to 0.1%): Eosinophilic pneumonia, interstitial lung disease[Ref]

Nasopharyngitis occurred more frequently in patients 13 to 17 years of age with fibromyalgia.[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 13%)

Common (1% to 10%): Abnormal dreams, abnormal orgasm, agitation, anorgasmia, anxiety, decreased libido/decreased sex drive, restlessness, sleep disorder, tension

Uncommon (0.1% to 1%): Apathy, bruxism, confusional state, disorientation, irritability, mood swings, nervousness, nightmares, suicidal ideation, suicide attempt

Rare (0.01% to 0.1%): Aggression, anger, completed suicide, hallucinations, mania, suicidal behavior

Frequency not reported: Activation of hypomania, early morning awakening, initial insomnia, intense dreams, loss of libido, middle insomnia, sleep disturbances, terminal insomnia[Ref]

Aggression and/or anger usually occurred initially or after stopping treatment.

Insomnia occurred most frequently in patients given 60 mg orally 2 times a day (N=225); the side effect occurred in 8% of patients given 60 mg orally once a day, and in 9% of patients given 20 mg orally once a day.[Ref]

Other

Very common (10% or more): Fatigue (up to 12%)

Common (1% to 10%): Asthenia, chills, falls, feeling jittery, pyrexia, rigors, tinnitus

Uncommon (0.1% to 1%): Ear pain, feeling abnormal, feeling cold/hot, malaise

Frequency not reported: Clinically important drug interactions[Ref]

Fatigue occurred most frequently in patients given 60 mg orally 2 times a day (N=225); the side effect occurred in 10% of patients given 60 mg orally once a day, and in 2% of patients given 20 mg orally once a day.

Falls were more common in patients 65 years and older.

Tinnitus was reported during treatment discontinuation.[Ref]

Genitourinary

Common (1% to 10%): Ejaculation delayed, ejaculation disorder, erectile dysfunction, polyuria, urinary frequency

Uncommon (0.1% to 1%): Abnormal urine odor, dysuria, ejaculation dysfunction, ejaculation failure, menopausal symptoms, micturition urgency, nocturia, sexual dysfunction, testicular pain, urinary hesitation, urinary retention

Rare (0.01% to 0.1%): Decreased urine flow, menstrual disorder

Very rare (less than 0.01%): Galactorrhea, gynecological bleeding

Frequency not reported: Genital hypoesthesia, problems getting/keeping an erection[Ref]

Musculoskeletal

Common (1% to 10%): Muscle cramp, muscle spasms, musculoskeletal pain, myalgia, neck pain

Uncommon (0.1% to 1%): Blood creatine phosphokinase increased, muscle tightness, muscle twitching, musculoskeletal stiffness, trismus

Postmarketing reports: Rhabdomyolysis[Ref]

Cardiovascular

Common (1% to 10%): Blood pressure increased, flushing/hot flush, palpitations

Uncommon (0.1% to 1%): Atrial fibrillation, chest pain, hypertension, increased diastolic blood pressure, increased systolic blood pressure, myocardial infarction, orthostatic hypertension, peripheral coldness, supraventricular arrhythmia, tachycardia, Takotsubo cardiomyopathy

Rare (0.01% to 0.1%): Hypertensive crisis, supraventricular fibrillation

Frequency not reported: Diastolic hypertension, essential hypertension, labile hypertension, pulse increased, secondary hypertension, systolic hypertension

Postmarketing reports: Cardiac events, ventricular arrhythmias[Ref]

Orthostatic hypotension was reported, especially during treatment initiation.[Ref]

Dermatologic

Cutaneous vasculitis was sometimes associated with systemic involvement.[Ref]

Common (1% to 10%): Hyperhidrosis/increased sweating, pruritus, rash

Uncommon (0.1% to 1%): Cold sweat, contact dermatitis, erythema, night sweats, photosensitivity reaction, urticaria

Rare (0.01% to 0.1%): Ecchymosis

Very rare (less than 0.01%): Cutaneous vasculitis, contusion, Stevens-Johnson syndrome

Frequency not reported: Severe skin reactions, subcutaneous tissue disorder[Ref]

Ocular

Common (1% to 10%): Blurred vision

Uncommon (0.1% to 1%): Diplopia, dry eye, mydriasis, visual impairment

Rare (0.01% to 0.1%): Glaucoma

Frequency not reported: Angle-closure glaucoma[Ref]

Immunologic

Common (1% to 10%): Influenza

Uncommon (0.1% to 1%): Laryngitis[Ref]

Hepatic

Uncommon (0.1% to 1%): Acute liver injury, ALT elevation, alkaline phosphatase elevation, AST elevation, blood bilirubin increased, elevated liver enzymes, GGT increased, hepatitis

Rare (0.01% to 0.1%): Hepatic failure, jaundice

Frequency not reported: Hepatotoxicity, liver failure[Ref]

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism

Rare (0.01% to 0.1%): Hyperprolactinemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH)[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity disorder

Rare (0.01% to 0.1%): Anaphylactic reaction

Very rare (less than 0.01%): Angioneurotic edema, hypersensitivity[Ref]

Hematologic

Uncommon (0.1% to 1%): Increased tendency to bruise

Postmarketing reports: Abnormal bleeding events, blood dyscrasias[Ref]

Renal

Postmarketing reports: Renal dysfunction[Ref]

Frequently asked questions

References

1. "Product Information. Cymbalta (duloxetine)." Lilly, Eli and Company (2004):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.