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Atomoxetine Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 13, 2023.

Applies to atomoxetine: oral capsule.

Warning

Oral route (Capsule)

Suicidal Ideation in Children and AdolescentsAtomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need. Comorbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Atomoxetine is approved for ADHD in pediatric and adult patients. Atomoxetine is not approved for major depressive disorder.Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving atomoxetine compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials.

Serious side effects of Atomoxetine

Along with its needed effects, atomoxetine 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 atomoxetine:

Less common

Rare

Incidence not known

Other side effects of Atomoxetine

Some side effects of atomoxetine 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:

More common

Less common

Incidence not known

For Healthcare Professionals

Applies to atomoxetine: oral capsule.

Gastrointestinal

Very common (10% or more): Dry mouth (up to 35%), nausea (up to 26%), abdominal pain/discomfort (up to 18%), constipation (up to 11%), vomiting (up to 11%)

Common (1% to 10%): Dyspepsia, gastroenteritis, diarrhea, flatulence[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 24%)

Common (1% to 10%): Decreased weight, anorexia[Ref]

Cardiovascular

Very common (10% or more): Increased heart rate (up to 23.4%), increased blood pressure (up to 21.5%)

Common (1% to 10%): Orthostatic hypotension, palpitations, flushing/hot flush, sinus tachycardia, tachycardia

Uncommon (0.1% to 1%): QT interval prolongation

Rare (less than 0.1%): Raynaud's phenomenon and/or peripheral vascular instability

Frequency not reported: Myocardial infarction[Ref]

Endocrine

Very common (10% or more): Erectile dysfunction (up to 21%)

Common (1% to 10%): Dysmenorrhea, delayed ejaculation/ejaculation disorder/ejaculation failure, sexual dysfunction, impotence, prostatitis, abnormal orgasm, irregular menstruation, testicular pain, male genital pain

Postmarketing reports: Priapism, male pelvic pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 19%), somnolence/sedation (up to 11%)

Common (1% to 10%): Dizziness, tremor, syncope/syncope vasovagal, paraesthesia, feeling jittery, dysgeusia

Uncommon (0.1% to 1%): Seizures, hypoesthesia

Frequency not reported: Stroke[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 19%)

Common (1% to 10%): Aggression/hostility, irritability, mood swings, depression/depressed mood, early morning awakening, abnormal dreams, decreased libido, sleep disorder, agitation, anxiety

Uncommon (0.1% to 1%): Suicide-related behavior (suicide attempts, suicidal ideation), psychotic/manic symptoms (e.g., hallucinations, delusional thinking, mania), restlessness, emotional lability, generalized anxiety disorder

Frequency not reported: Panic attacks, impulsivity, akathisia, hypomania

Postmarketing reports: Tics, libido changes, sensory disturbances, completed suicide[Ref]

Dermatologic

Very common (10% or more): Hyperhidrosis (up to 15%)

Common (1% to 10%): Rash, excoriation, dermatitis, pruritus

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

Other

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

Common (1% to 10%): Unexpected therapeutic response, chills, thirst, peripheral coldness/feeling cold, influenza, pyrexia, rigors, lethargy, asthenia, chest pain

Frequency not reported: Delayed growth (height and weight), sudden death[Ref]

Genitourinary

Common (1% to 10%): Urinary retention, urinary hesitation/decreased urine flow, dysuria, pollakiuria

Uncommon (0.1% to 1%): Micturition urgency, enuresis[Ref]

Ocular

Common (1% to 10%): Conjunctivitis, mydriasis, blurred vision[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection

Uncommon (0.1% to 1%): Pharyngitis, dyspnea

Frequency not reported: Pharyngolaryngeal pain, oropharyngeal pain[Ref]

Hepatic

Uncommon (0.1% to 1%): Increased blood bilirubin

Rare (less than 0.1%): Liver failure, abnormal/increased liver function tests, jaundice, hepatitis, liver injury, acute hepatic failure[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions (anaphylactic reactions, angioneurotic edema, urticarial, rash)[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle spasms

Frequency not reported: Back pain

Postmarketing reports: Rhabdomyolysis[Ref]

Frequently asked questions

References

1. Product Information. Strattera (atomoxetine). Lilly, Eli and Company. 2002.

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.