Important Safety Information

Qsymia is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity or idiosyncrasy to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.

Qsymia can cause fetal harm. Patients of reproductive potential should have a pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.

Topiramate increases the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Qsymia in patients who experience suicidal thoughts or behaviors. Qsymia is not recommended in patients with a history of suicidal attempts or active suicidal ideation.

Acute angle closure glaucoma has been reported in patients treated with topiramate. Symptoms include acute onset of decreased visual acuity and/or eye pain. Symptoms typically occur within 1 month of initiating treatment with topiramate but may occur at any time during therapy. The primary treatment to reverse symptoms is immediate discontinuation of Qsymia.

Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate. In clinical trials, most of these events were reversible after topiramate discontinuation.

Qsymia can cause mood disorders, including depression, and anxiety, as well as insomnia. Qsymia can cause cognitive dysfunction (e.g., impairment of concentration/attention, difficulty with memory, and speech or language problems, particularly word-finding difficulties). Since Qsymia has the potential to impair cognitive function, patients should be cautioned about operating hazardous machinery, including automobiles.

Hyperchloremic, non-anion gap, metabolic acidosis has been reported in patients treated with Qsymia. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Qsymia.

Qsymia can cause an increase in serum creatinine. If persistent elevations in creatinine occur while taking Qsymia, reduce the dose or discontinue Qsymia.

Qsymia can cause slowing of linear growth. Consider dosage reduction or discontinuation if pediatric patients are not growing or gaining height as expected.

Qsymia can cause serious skin reactions and should be discontinued at the first sign of a rash, unless the rash is clearly not drugrelated.

The most commonly observed side effects in controlled clinical studies, ≥5% and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.

To report negative side effects, contact VIVUS LLC at 1-888-998-4887 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.