Note: This document contains side effect information about duloxetine. Some dosage forms listed on this page may not apply to the brand name Drizalma Sprinkle.
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]
