Drug Safety Information for ZYLOPRIM (Allopurinol)

Safety-related Labeling Changes for ZYLOPRIM (ALLOPURINOL) Rx Drug: FDA Link

Safety-related Labeling Changes for ALOPRIM (ALLOPURINOL SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for ZYLOPRIM* (Allopurinol)

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 ZYLOPRIM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Renal failure acute2301
2Dyspnoea2241
3Pyrexia2135
4Diarrhoea2119
5Anaemia2041
6Nausea1973
7Renal failure1785
8Asthenia1639
9Fatigue*1596
10Pneumonia1569
11Vomiting1470
12Hypotension1395
13Dizziness*1364
14Drug interaction1361
15Oedema peripheral1294
16Blood creatinine increased1278
17Rash*1276
18Haemoglobin decreased1220
19Malaise1218
20Fall1201

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

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

Reason # of FDA Reports
1Product used for unknown indication21364
2Gout*18105
3Hyperuricaemia12906
4Prophylaxis4002
5Blood uric acid increased1153
6Nephrolithiasis*812
7Tumour lysis syndrome678
8Blood uric acid*485
9Renal failure472
10Gouty arthritis*449

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


Types of Adverse Events for ZYLOPRIM

Total Reports Filed with FDA: 211454


Number of FDA Adverse Event Reports by Patient Age for ZYLOPRIM

Total Reports Filed with FDA: 211454*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Allopurinol (Milurit, Cellidrin, Hamarin, Purinol, Remid, Jenapurinol, Allural, Alloprin, Foligan, Lopurin, Uripurinol, Apurin, Allohexal, Bleminol, Novopurol, Allorin, Urosin, Tipuric, Zyloric, Allopurin, Progout, Zyloprim, Allopurinol)

Charts are based on 211454 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 ZYLOPRIM 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.