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.
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.
5.1 Coadministration With Other Drug Products for Weight Loss Phentermine hydrochloride tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity.
The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established.
Therefore, coadministration of phentermine and these drug products is not recommended.
5.2 Primary Pulmonary Hypertension Primary Pulmonary Hypertension (PPH) – a rare, frequently fatal disease of the lungs has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine.
The possibility of an association between PPH and the use of phentermine alone cannot be ruled out;
Like all medications, Phentermine Hcl C-Iv 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: