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Human Experience

No fatal overdoses occurred in clinical trials. There is limited clinical trial experience with STRATTERA (atomoxetine hcl) overdose. During postmarketing, there have been fatalities reported involving a mixed ingestion overdose of STRATTERA (atomoxetine hcl) and at least one other drug. There have been no reports of death involving overdose of STRATTERA (atomoxetine hcl) alone, including intentional overdoses at amounts up to 1400 mg. In some cases of overdose involving STRATTERA (atomoxetine hcl) , seizures have been reported. The most commonly reported symptoms accompanying acute and chronic overdoses of STRATTERA (atomoxetine hcl) were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behavior. Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g., tachycardia, blood pressure increased, mydriasis, dry mouth) have also been observed. Most events were mild to moderate. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations.

Management of Overdose

Consult with a Certified Poison Control Center for up to date guidance and advice. Because atomoxetine is highly proteinbound, dialysis is not likely to be useful in the treatment of overdose.

Hypersensitivity

STRATTERA (atomoxetine hcl) is contraindicated in patients known to be hypersensitive to atomoxetine or other constituents of the product [see STRATTERA WARNINGS AND STRATTERA PRECAUTIONS].

Monoamine Oxidase Inhibitors (MAOI)

STRATTERA (atomoxetine hcl) should not be taken with an MAOI, or within 2 weeks after discontinuing an MAOI. Treatment with an MAOI should not be initiated within 2 weeks after discontinuing STRATTERA (atomoxetine hcl) . With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) when taken in combination with an MA OI. Some cases presented with features resembling neuroleptic malignant syndrome. Such reactions may occur when these drugs are given concurrently or in close proximity [see STRATTERA DRUG INTERACTIONS].

Narrow Angle Glaucoma

In clinical trials, STRATTERA (atomoxetine hcl) use was associated with an increased risk of mydriasis and therefore its use is not recommended in patients with narrow angle glaucoma.

Pheochromocytoma

Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received STRATTERA (atomoxetine hcl). Therefore, STRATTERA (atomoxetine hcl) should not be taken by patients with pheochromocytoma or a history of pheochromocytoma.

Last reviewed on RxList: 4/29/2011
This monograph has been modified to include the generic and brand name in many instances.