From the Guidelines
Strattera (atomoxetine) can cause several side effects, including common ones like decreased appetite, nausea, vomiting, fatigue, and somnolence, as well as more serious ones like suicidal thoughts, allergic reactions, and priapism, as noted in the most recent study 1.
Common Side Effects
- Decreased appetite
- Nausea
- Vomiting
- Fatigue
- Upset stomach
- Dizziness
- Dry mouth
- Constipation
- Mood swings These side effects are often seen in the first few weeks of treatment and may diminish over time 1.
Serious Side Effects
- Increased blood pressure
- Increased heart rate
- Liver problems (indicated by yellowing of skin/eyes, dark urine, abdominal pain)
- Suicidal thoughts
- Allergic reactions
- Priapism (painful, prolonged erection) Strattera carries a black box warning for increased risk of suicidal thinking in children and adolescents, as reported in 1 and 1.
Special Considerations
- Children and adolescents may experience weight loss and slowed growth, which may return to expected measurements after 2 to 3 years of treatment, as noted in 1.
- Patients should not stop taking Strattera suddenly without consulting their healthcare provider, as this can cause withdrawal symptoms.
- The medication works by increasing norepinephrine levels in the brain, which helps improve attention and reduce impulsivity and hyperactivity in ADHD patients, but these neurotransmitter changes also contribute to the side effect profile, as explained in 1.
Dosage and Administration
- The usual starting dose of atomoxetine is 40 mg po daily, with titration every 7-14 days to 60 then 80 mg/d, as recommended in 1.
- The total maximum dose is recommended as the lesser of 1.4 mg/kg/d or 100 mg/d.
From the FDA Drug Label
Atomoxetine hydrochloride was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies. During the ADHD clinical trials, 1625 children and adolescent patients were treated for longer than 1 year and 2529 children and adolescent patients were treated for over 6 months The most commonly observed adverse reactions in patients treated with atomoxetine hydrochloride (incidence of 5% or greater and at least twice the incidence in placebo patients, for either BID or QD dosing) were: nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence Table 2: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine Hydrochloride in Acute (up to 18 weeks) Child and Adolescent Trials Adverse Reactiona Percentage of Patients Reporting Reaction Atomoxetine Hydrochloride (N=1597)Placebo(N=934) Gastrointestinal Disorders Abdominal painb1810 Vomiting 116 Nausea105 General Disorders and Administration Site Conditions Fatigue83 Irritability63 The following reactions did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: blood pressure increased, early morning awakening (terminal insomnia), flushing, mydriasis, sinus tachycardia, asthenia, palpitations, mood swings, constipation and dyspepsia
The side effects of Strattera (Atomoxetine) include:
- Gastrointestinal disorders:
- Abdominal pain
- Vomiting
- Nausea
- General disorders:
- Fatigue
- Irritability
- Other reactions:
- Decreased appetite
- Somnolence
- Blood pressure increased
- Early morning awakening
- Flushing
- Mydriasis
- Sinus tachycardia
- Asthenia
- Palpitations
- Mood swings
- Constipation
- Dyspepsia 2
From the Research
Side Effects of Strattera (Atomoxetine)
The side effects of Strattera (Atomoxetine) include:
- Common adverse events such as headache, abdominal pain, decreased appetite, vomiting, somnolence, and nausea 3, 4
- Gastro-intestinal disorders and decreased appetite, which are generally noted to be transient 4
- Dry mouth, insomnia, nausea, constipation, dizziness, sweating, dysuria, sexual problems, and palpitations 5
- Modest increases in heart rate and blood pressure, which are well tolerated and gradually decrease on cessation of treatment 5
- Cardiovascular side effects such as syncope, orthostatic hypotension, and tachycardia 6
- Seizure and mild cardiac toxicity in cases of overdose 7
- Rarely, atomoxetine may also be associated with serious liver injury 3
- A black-box warning for suicidal ideation has been published in the US prescribing information, based on findings from a meta-analysis showing that atomoxetine is associated with a significantly higher incidence of suicidal ideation than placebo 3
Special Considerations
- Atomoxetine can be administered once or twice daily, and its subjective-effects profile is different from that of methylphenidate 5
- Atomoxetine is not associated with abuse or diversion, and it is therefore not a controlled substance in the US 5
- Atomoxetine is a valuable new treatment option for adults with ADHD, particularly useful in patients who are at risk for substance abuse or who do not wish to take a controlled substance 5