Strattera Side Effects

Generic name: atomoxetine

Note: This document contains side effect information about atomoxetine. Some of the dosage forms listed on this page may not apply to the brand name Strattera.

Some side effects of Strattera may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to atomoxetine: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking atomoxetine (the active ingredient contained in Strattera) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking atomoxetine and call your doctor at once if you have a serious side effect such as:

• chest pain, shortness of breath, fast or uneven heartbeats;

• feeling like you might pass out;

• unusual thoughts or behavior, aggression, hallucinations (seeing things that are not there);

• nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• increased blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, seizure);

• urinating less than usual or not at all; or

• numbness, burning pain, or tingly feeling.

Less serious side effects of atomoxetine may include:

• feeling irritable;

• feeling dizzy or drowsy;

• constipation;

• cough, dry mouth;

• skin rash or itching;

• sleep problems (insomnia);

• increased menstrual cramps; or

• impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to atomoxetine: oral capsule

Genitourinary

Genitourinary side effects reported in adult placebo-controlled trials have included urinary hesitation and/or urinary retention and/or difficulty in micturition (8%), dysmenorrhea (7%), erectile disturbance (7%), ejaculation failure and/or ejaculation disorder (up to 5%), impotence (3%), menstrual disorder (3%), prostatitis (3%), delayed menses, irregular menstruation (2%), and abnormal orgasm (2%). Priapism, hemospermia, and male pelvic pain have been reported in postmarketing experience.

Cardiovascular

Cardiovascular side effects reported in adult placebo-controlled trials have included palpitations (up to 4%), tachycardia (3%), increased heart rate, and increased blood pressure. Orthostatic hypotension and syncope have been reported in clinical trials. New onset and exacerbation of existing Raynaud's phenomenon as well as QT prolongation have been reported in postmarketing experience.

In adult placebo-controlled trials the mean increase in heart rate was reported as 5 beats/minute and the mean increase in blood pressure was reported as 3 mm Hg systolic and 1 mm Hg diastolic.

Hepatic

Hepatic side effects have included severe hepatic injury.

Two cases of severe liver injury (a teenager and an adult) following treatment with atomoxetine for a duration of at least several months have been reported. Both patients recovered. Two additional cases of hepatitis have been reported in children (11 and 12 years of age) following treatment with atomoxetine (30 to 40 mg/day). Symptoms included jaundice, abdominal pain, fatigue, weight loss, arthralgias, diarrhea, vomiting, and elevated liver enzymes. Liver injury completely resolved in both patients following discontinuation of atomoxetine. The number of actual cases of severe liver injury is unknown because of underreporting of postmarketing adverse events.

Atomoxetine should be discontinued in patients who develop jaundice (yellowing of the skin or whites of the eyes) or have laboratory evidence of liver injury. Signs and symptoms of liver problems can include pruritus (itchy skin), jaundice, dark urine, upper right-sided abdominal tenderness, or unexplained flu-like symptoms. Health care professionals are encouraged to report any unexpected adverse events associated with atomoxetine directly to Eli Lilly at 1800-LillyRx or to the FDA MedWatch program at 1800-FDA-1088.

Gastrointestinal

Gastrointestinal side effects reported in adult placebo-controlled trials have included dry mouth (21%), nausea (up to 21%), constipation (up to 10%), abdominal pain (7%), dyspepsia (up to 6%), vomiting (3%), and flatulence (2%). One case of sialolithiasis in association with atomoxetine (the active ingredient contained in Strattera) has been reported and confirmed upon several rechallenges.

Respiratory

Respiratory side effects reported in adult placebo-controlled trials have included sinusitis (6%).

Musculoskeletal

Musculoskeletal side effects reported in adult placebo-controlled trials have included myalgia (3%).

Nervous system

Nervous system side effects reported in adult placebo-controlled trials have included headache (17%), insomnia and/or middle insomnia (16%), dizziness (6%), paraesthesia (4%), somnolence (4%), sinus headache (3%), and tremor (2%). Seizures have been reported in 0.1% of adult patients. There have also been postmarketing reports of hypoesthesia and sensory disturbances.

Psychiatric

Psychiatric side effects reported in adult placebo-controlled trials have included insomnia (15%), decreased libido (up to 6%), abnormal dreams (4%), and sleep disorders (up to 4%). Mania has been reported rarely. Treatment emergent hostility-related effects have been reported in short-term clinical trials. Patients beginning therapy should be monitored for the appearance or worsening of aggression or hostility.

An 11-year-old male with attention deficit disorder developed mania after approximately 3 to 4 weeks of treatment with atomoxetine. The patient returned to his baseline behaviors within 7 days of discontinuing atomoxetine.

Dermatologic

Dermatologic side effects reported in adult placebo-controlled trials have included increased sweating (4%), dermatitis (2%), and rash (2%).

Hypersensitivity

Hypersensitivity side effects have rarely included angioneurotic edema, urticaria, and rash.

Ocular

Ocular side effects have included an increased risk of mydriasis.

Other

Other side effects reported in adult placebo-controlled trials have included decreased appetite (up to 11%), fatigue (up to 9%), hot flushes (up to 8%), pyrexia (3%), rigors (3%), unexpected therapeutic response (3%), chills (3%), jittery feeling (2%), and weight loss (2%). Postmarketing side effects reported have included Raynaud's phenomenon and paraesthesia in children and adolescents.

Acute treatment studies of up to 9 weeks in duration have reported an average weight loss of 0.4 kg.

Renal

Renal side effects including urinary hesitation and/or urinary retention (7%), and dysuria (3%) have been reported.

General

General side effects including lethargy have been reported.

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