Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: Primary pulmonary hypertension [ see Warnings and Precautions (5.2) ] Valvular heart disease [ see Warnings and Precautions (5.3) ] Effect on the ability to engage in potentially hazardous tasks [ see Warnings and Precautions (5.5) ] Withdrawal effects following prolonged high dosage administration [ see Drug Abuse and Dependence (9.3) ] The following adverse reactions to phentermine have been identified: Cardiovascular Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.
Central Nervous System Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.
Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.
Allergic Urticaria.
Endocrine Impotence, changes in libido.
Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc.
at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS Coadministration with other drugs for weight loss is not recommended (safety and efficacy of combination not established).
( 5.1 ) Rare cases of primary pulmonary hypertension have been reported.
Phentermine should be discontinued in case of new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema.
( 5.2 ) Rare cases of serious regurgitant cardiac valvular disease have been reported.
( 5.3 ) Tolerance to the anorectic effect usually develops within a few weeks.
Like all medications, Phentermine Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: