Tenuate Dospan Side Effects

Generic name: diethylpropion

Note: This document contains side effect information about diethylpropion. Some of the dosage forms listed on this page may not apply to the brand name Tenuate Dospan.

Some side effects of Tenuate Dospan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to diethylpropion: oral tablet, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking diethylpropion (the active ingredient contained in Tenuate Dospan) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using diethylpropion and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeats;

• chest pain, feeling short of breath (even with mild exertion);

• feeling like you might pass out;

• swelling in your ankles or feet;

• confusion, hallucinations, unusual thoughts or behavior;

• seizure (convulsions);

• muscle movements you cannot control; or

• sudden numbness or weakness, especially on one side of the body.

Less serious side effects of diethylpropion may include:

• nausea, vomiting, diarrhea, upset stomach;

• headache, blurred vision;

• feeling nervous, anxious, or jittery;

• sleep problems (insomnia);

• dizziness, drowsiness, tired feeling;

• depressed mood;

• dry mouth, unpleasant taste in your mouth;

• decreased sex drive; or

• mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to diethylpropion: oral tablet, oral tablet extended release

Cardiovascular

Cardiovascular side effects including precordial pain, arrhythmia, ECG changes, tachycardia, elevation of blood pressure, and palpitation have been reported. Pulmonary hypertension has been reported rarely. Valvulopathy has been reported very rarely.

A causal relationship between diethylpropion and valvulopathy has not been reported. Valvular heart disease has been reported with the use of other anorectic agents.

Nervous system

Nervous system side effects including dyskinesia, blurred vision, overstimulation, nervousness, restlessness, dizziness, jitteriness, insomnia, anxiety, euphoria, depression, dysphoria, tremor, mydriasis, drowsiness, malaise, headache, and cerebrovascular accident have been reported. Psychotic episodes have rarely been reported (at recommended doses). An increase in convulsive episodes has been reported in a few epileptics.

Respiratory

Respiratory side effects including dyspnea have been reported. One study has reported that the use of anorectic agents including diethylpropion (the active ingredient contained in Tenuate Dospan) for longer than three months was associated with a 23-fold increase in the risk of developing pulmonary hypertension.

Psychiatric

Psychiatric side effects including psychological dependence and psychosis have been reported.

Gastrointestinal

Gastrointestinal side effects including vomiting, diarrhea, abdominal discomfort, dryness of the mouth, unpleasant taste, nausea, constipation, and other gastric disturbances have been reported.

Dermatologic

Dermatologic side effects including urticaria, rash, ecchymosis, erythema, hair loss, and increased sweating have been reported.

Endocrine

Endocrine side effects including impotence, changes in libido, gynecomastia, and menstrual upset have been reported.

Hematologic

Hematologic side effects including bone marrow depression, agranulocytosis, and leukopenia have been reported.

Genitourinary

Genitourinary side effects including dysuria and polyuria have been reported. Two cases of gynecomastia have also been reported.

Musculoskeletal

Musculoskeletal side effects including muscle pain have been reported.

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