ADIPEX-P® (phentermine hydrochloride USP, 37.5 mg CIV) is used to
treat obesity for a short period of time (a few weeks), as part of a treatment plan
that includes exercise, behavioral changes, and a low-calorie diet, for people with
a body mass index ≥30 kg/m2or a body mass index ≥27 kg/m2
with other risk factors (eg, high blood pressure, diabetes, elevated cholesterol).
IMPORTANT SAFETY INFORMATION
People with the following medical conditions should not take ADIPEX-P®:
Those with a history of cardiovascular disease (hardening of the arteries, stroke,
congestive heart failure, and/or moderate to severe high blood pressure), overactive
thyroid, glaucoma (increased pressure in the eyes), hypersensitivity to stimulants,
agitation, those with a history of drug abuse, those who are pregnant or nursing,
and those who have used a monoamine oxidase inhibitor drug (MAOI) within the past
14 days. Some side effects of ADIPEX-P® include elevated blood pressure, insomnia,
restlessness, dry mouth, diarrhea, or changes in sexual drive. Primary pulmonary
hypertension (PPH), a rare fatal lung disease, has been reported in patients taking
both phentermine and fenfluramine or dexfenfluramine. The possible association between
phentermine use alone and PPH or valvular heart disease cannot be ruled out. There
have been rare cases of PPH or valvular heart disease in patients who reportedly
have taken phentermine alone. The safety and benefit of taking other drugs with
ADIPEX-P® for weight loss have not been established.
You are encouraged to report negative side effects of prescription drugs to the
FDA at www.fda.gov/medwatch
or call 1-800-FDA-1088.