Drug Safety Information for TRENTAL (Pentoxifylline)

Safety-related Labeling Changes for TRENTAL (PENTOXIFYLLINE) Rx Drug: FDA Link

Adverse Drug Reactions for TRENTAL* (Pentoxifylline)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with TRENTAL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea143
2Nausea*125
3Asthenia116
4Pain114
5Dizziness110
6Diarrhoea*106
7Oedema peripheral105
8Vomiting*101
9Drug ineffective*101
10Anaemia100
11Cerebrovascular accident97
12Fatigue94
13Myocardial infarction94
14Pneumonia93
15Hypotension87
16Pain in extremity85
17Weight decreased82
18Anxiety80
19Pyrexia79
20Death79

* This side effect also appears in "Top 10 Side Effects of TRENTAL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking TRENTAL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication1023
2Trismus164
3Peripheral vascular disorder154
4Pain in extremity116
5Cardiovascular disorder107
6Atrial fibrillation95
7Peripheral arterial occlusive disease83
8Intermittent claudication82
9Cardiovascular insufficiency52
10Cerebrovascular accident46

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for TRENTAL

Total Reports Filed with FDA: 13559


Number of FDA Adverse Event Reports by Patient Age for TRENTAL

Total Reports Filed with FDA: 13559*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pentoxifylline (Pentoxil, Torental, Agapurin, Pentoxifylline, Trental)

Charts are based on 13559 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and TRENTAL Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.