Trental Side Effects

Generic Name: pentoxifylline

Please note - some side effects for Trental may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Trental - for the Consumer

Trental

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Trental:

Belching; bloating; blurred vision; diarrhea; dizziness; flushing; gas; headache; indigestion; nausea; stomach discomfort.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; irregular heartbeat; vomiting.

Trental Side Effects - for the Professional

Trental

Clinical trials were conducted using either extended-release Trental tablets for up to 60 weeks or immediate-release Trental capsules for up to 24 weeks. Dosage ranges in the tablet studies were 400 mg bid to tid and in the capsule studies, 200–400 mg tid. The table summarizes the incidence (in percent) of adverse reactions considered drug related, as well as the numbers of patients who received extended-release Trental tablets, immediate-release Trental capsules, or the corresponding placebos. The incidence of adverse reactions was higher in the capsule studies (where dose related increases were seen in digestive and nervous system side effects) than in the tablet studies. Studies with the capsule include domestic experience, whereas studies with the extended-release tablets were conducted outside the U.S.

The table indicates that in the tablet studies few patients discontinued because of adverse effects.

Trental has been marketed in Europe and elsewhere since 1972. In addition to the above symptoms, the following have been reported spontaneously since marketing or occurred in other clinical trials with an incidence of less than 1%; the causal relationship was uncertain:

    

Cardiovascular - dyspnea, edema, hypotension.

    

Digestive - anorexia, cholecystitis, constipation, dry mouth/thirst.

    

Nervous - anxiety, confusion, depression, seizures, aseptic meningitis.

    

Respiratory - epistaxis, flu-like symptoms, laryngitis, nasal congestion.

    

Skin and Appendages - brittle fingernails, pruritus, rash, urticaria, angioedema.

    

Special Senses - blurred vision, conjunctivitis, earache, scotoma.

    

Miscellaneous - bad taste, excessive salivation, leukopenia, malaise, sore throat/swollen neck glands, weight change.

A few rare events have been reported spontaneously worldwide since marketing in 1972. Although they occurred under circumstances in which a causal relationship with pentoxifylline could not be established, they are listed to serve as information for physicians. Cardiovascular — angina, arrhythmia, tachycardia, anaphylactoid reactions. Digestive — hepatitis, jaundice, increased liver enzymes; and Hemic and Lymphatic — decreased serum fibrinogen, pancytopenia, aplastic anemia, leukemia, purpura, thrombocytopenia.

Side Effects by Body System

General

Pentoxifylline has been generally well tolerated. While typically minor, side effects have necessitated discontinuation of the drug in approximately 3% of treated patients. Tolerance to mild side effects generally has developed with continued use.

Gastrointestinal

Gastrointestinal side effects have been the most common side effects associated with pentoxifylline therapy and have included dyspepsia, nausea, vomiting, and belching, which occurred in 1% to 3% of patients. Some smaller studies have reported gastrointestinal disturbance in up to 33% of patients treated with pentoxifylline.

Nervous system

Nervous system side effects have occurred in 1% to 2% of treated patients and have included headache, dizziness, insomnia, and tremor. Some smaller studies have reported nervous system adverse effects in up to 17% of treated patients. In addition, rare cases of visual and auditory hallucinations have been reported. Aseptic meningitis has been reported in postmarketing experiences.

Cardiovascular

Cardiovascular side effects have included reports of palpitations, flushing, and angina. These reports have usually been associated with higher doses of an immediate release capsule which is not available in the United States.

Hematologic

Hematologic side effects have included anecdotal reports of pancytopenia and fatal aplastic anemia.

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