TRENTAL SIDE EFFECTS

SIDE EFFECTS

Clinical Trial Adverse Drug Reactions

Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

The most frequent adverse event reported with Trental (pentoxifylline) is nausea (14%). Individual signs/symptoms listed in the table below occurred at an incidence between 1 and 3%, except when stated otherwise.

Less Common Clinical Trial Adverse Drug Reactions ( < 1%)

Body as a whole: Muscle aches/spasm, weight change, backache, bad taste in mouth, leg cramps, fever, weakness, sweating.

Cardiovascular: Chest pain, arrhythmia, hypertension, dyspnea, edema, hypotension, angina, tachycardia.

Central nervous system: Drowsiness/sleepiness, tremor, agitation anxiety, confusion, insomnia, restlessness.

Gastrointestinal: Abdominal burning, abdominal pain, anorexia flatus, constipation, haemorrhage, heartburn, salivation, dry mouth/throat, hepatitis, jaundice, increased liver enzymes.

Hemic and lymphatic: Decreased serum fibrinogen, pancytopenia, purpura, thrombocytopenia, leucopenia, anemia, aplastic anemia.

Hypersensitivity reactions: Pruritis, rash, urticaria, angioedema.

Organs of special sense: Blurred vision, scotoma, lacrimation, epistaxis.

Post-Market Adverse Drug Reactions

Hepatobiliary disorders: Intrahepatic cholestasis.

Immune system disorders: Severe anaphylactic/anaphylactoid reaction with, for example, angioneurotic edema, bronchospasms, sometimes shock.

Infections and infestations: Aseptic meningitis.

Investigations: Transaminase elevation.

Psychiatric: Sleep disturbances.

Skin and subcutaneous tissue disorders: Reddening of skin.

Vascular disorder: Haemorrhage