Pentoxifylline Side Effects

Some side effects of pentoxifylline 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 pentoxifylline: oral tablet extended release

Stop taking this medication and Get emergency medical help if you have any of these signs of an allergic reaction while taking pentoxifylline: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• chest pain,

• pounding heartbeats or fluttering in your chest;

• feeling like you might pass out;

• red or pink urine;

• bloody, black, or tarry stools; or

• coughing up blood or vomit that looks like coffee grounds.

Less serious side effects of pentoxifylline may include:

• dizziness, headache;

• blurred vision;

• flushing (warmth, redness, or tingly feeling);

• gas, bloating, upset stomach; or

• nausea, vomiting, diarrhea.

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 pentoxifylline: compounding powder, oral tablet extended release

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.

Hepatic

Hepatic side effects have included postmarketing reports of cholestasis.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of anaphylactic reaction, anaphylactoid reaction, and anaphylactic shock.

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