Home FDA labels f661a5aa-d807-4724-96c4-b8e5a2216f36 FDA label f661a5aa-d807-4724-96c4-b8e5a2216f36 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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SPL set ID af8bf978-45e7-4548-a314-beb205f36749
SPL ID f661a5aa-d807-4724-96c4-b8e5a2216f36
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Effective date 2018-06-15
Source export date 2026-10-12
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adverse reactions ADVERSE REACTIONS Clinical trials were conducted using either extended-release pentoxifylline tablets for up to 60 weeks or immediate-release pentoxifylline capsules for up to 24 weeks. Dosage ranges in the tablet studies were 400 mg bid to tid and in the capsule studies, 200 to 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 pentoxifylline tablets, immediate-release pentoxifylline 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. INCIDENCE (%) OF SIDE EFFECTS Extended-Release Tablets Immediate-Release Capsules Commercially Available Used only for Controlled Clinical Trials Pentoxifylline Placebo Pentoxifylline Placebo (Numbers of Patients at Risk) (321) (128) (177) (138) Discontinued for Side Effect 3.1 0 9.6 7.2 CARDIOVASCULAR SYSTEM Angina/Chest Pain 0.3 - 1.1 2.2 Arrhythmia/Palpitation - - 1.7 0.7 Flushing - - 2.3 0.7 DIGESTIVE SYSTEM Abdominal Discomfort - - 4.0 1.4 Belching/Flatus/Bloating 0.6 - 9.0 3.6 Diarrhea - - 3.4 2.9 Dyspepsia 2.8 4.7 9.6 2.9 Nausea 2.2 0.8 28.8 8.7 Vomiting 1.2 - 4.5 0.7 NERVOUS SYSTEM Agitation/Nervousness - - 1.7 0.7 Dizziness 1.9 3.1 11.9 4.3 Drowsiness - - 1.1 5.8 Headache 1.2 1.6 6.2 5.8 Insomnia - - 2.3 2.2 Tremor 0.3 0.8 - - Blurred Vision - - 2.3 1.4 Pentoxifylline 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 reaction; Digestive –hepatitis, jaundice, increased liver enzymes; and Hemic and Lymphatic –decreased serum fibrinogen, pancytopenia, aplastic anemia, leukemia, purpura, thrombocytopenia.
adverse reactions table <table ID="_Refid_c290e51f-f126-4099-a9ae-90f49bece" width="100%"> <caption>INCIDENCE (%) OF SIDE EFFECTS</caption> <col width="25%"/> <col width="25%"/> <col width="25%"/> <col width="25%"/> <thead> <tr> <th align="center" colspan="2" styleCode="Botrule Toprule " valign="top"> <content styleCode="bold">Extended-Release Tablets</content> </th> <th align="center" colspan="2" styleCode="Botrule Toprule " valign="top"> <content styleCode="bold">Immediate-Release Capsules</content> </th> </tr> <tr> <th align="center" colspan="2" valign="top"> <content styleCode="bold">Commercially Available</content> </th> <th align="center" colspan="2" valign="top"> <content styleCode="bold">Used only for Controlled Clinical Trials</content> </th> </tr> <tr> <th align="center" valign="top"> <content styleCode="bold">Pentoxifylline</content> </th> <th align="center" valign="top"> <content styleCode="bold">Placebo</content> </th> <th align="center" valign="top"> <content styleCode="bold">Pentoxifylline</content> </th> <th align="center" valign="top"> <content styleCode="bold">Placebo</content> </th> </tr> <tr> <th align="center" colspan="4" styleCode="Botrule " valign="top"> <content styleCode="bold">(Numbers of Patients at Risk)</content> </th> </tr> <tr> <th align="center" styleCode="Botrule " valign="top"> <content styleCode="bold">(321)</content> </th> <th align="center" styleCode="Botrule " valign="top"> <content styleCode="bold">(128)</content> </th> <th align="center" styleCode="Botrule " valign="top"> <content styleCode="bold">(177)</content> </th> <th align="center" styleCode="Botrule " valign="top"> <content styleCode="bold">(138)</content> </th> </tr> </thead> <tbody> <tr> <td colspan="4" styleCode="Toprule " valign="top"> <paragraph>Discontinued for Side Effect</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>3.1</paragraph> </td> <td align="center" valign="top"> <paragraph>0</paragraph> </td> <td align="center" valign="top"> <paragraph>9.6</paragraph> </td> <td align="center" valign="top"> <paragraph>7.2</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph>CARDIOVASCULAR SYSTEM</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Angina/Chest Pain</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>0.3</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>1.1</paragraph> </td> <td align="center" valign="top"> <paragraph>2.2</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Arrhythmia/Palpitation</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>1.7</paragraph> </td> <td align="center" valign="top"> <paragraph>0.7</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Flushing</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>2.3</paragraph> </td> <td align="center" valign="top"> <paragraph>0.7</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph>DIGESTIVE SYSTEM</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Abdominal Discomfort</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>4.0</paragraph> </td> <td align="center" valign="top"> <paragraph>1.4</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Belching/Flatus/Bloating</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>0.6</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>9.0</paragraph> </td> <td align="center" valign="top"> <paragraph>3.6</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Diarrhea</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>3.4</paragraph> </td> <td align="center" valign="top"> <paragraph>2.9</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Dyspepsia</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>2.8</paragraph> </td> <td align="center" valign="top"> <paragraph>4.7</paragraph> </td> <td align="center" valign="top"> <paragraph>9.6</paragraph> </td> <td align="center" valign="top"> <paragraph>2.9</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Nausea</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>2.2</paragraph> </td> <td align="center" valign="top"> <paragraph>0.8</paragraph> </td> <td align="center" valign="top"> <paragraph>28.8</paragraph> </td> <td align="center" valign="top"> <paragraph>8.7</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Vomiting</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>1.2</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>4.5</paragraph> </td> <td align="center" valign="top"> <paragraph>0.7</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph>NERVOUS SYSTEM</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Agitation/Nervousness</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>1.7</paragraph> </td> <td align="center" valign="top"> <paragraph>0.7</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Dizziness</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>1.9</paragraph> </td> <td align="center" valign="top"> <paragraph>3.1</paragraph> </td> <td align="center" valign="top"> <paragraph>11.9</paragraph> </td> <td align="center" valign="top"> <paragraph>4.3</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Drowsiness</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>1.1</paragraph> </td> <td align="center" valign="top"> <paragraph>5.8</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Headache</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>1.2</paragraph> </td> <td align="center" valign="top"> <paragraph>1.6</paragraph> </td> <td align="center" valign="top"> <paragraph>6.2</paragraph> </td> <td align="center" valign="top"> <paragraph>5.8</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Insomnia</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>2.3</paragraph> </td> <td align="center" valign="top"> <paragraph>2.2</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Tremor</paragraph> </td> </tr> <tr> <td align="center" valign="top"> <paragraph>0.3</paragraph> </td> <td align="center" valign="top"> <paragraph>0.8</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> <td align="center" valign="top"> <paragraph>-</paragraph> </td> </tr> <tr> <td colspan="4" valign="top"> <paragraph> Blurred Vision</paragraph> </td> </tr> <tr> <td align="center" styleCode="Botrule " valign="top"> <paragraph>-</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph>-</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph>2.3</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph>1.4</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.