Drug Safety Information for ALOPRIM (Allopurinol sodium)

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

Adverse Drug Reactions for ALOPRIM* (Allopurinol sodium)

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 ALOPRIM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia26
2Dyspnoea24
3Renal failure acute21
4Renal failure20
5Hypotension16
6Asthenia16
7Haemoglobin decreased15
8Drug ineffective15
9Dehydration14
10General physical health deterioration14
11Dizziness12
12Nausea12
13Platelet count decreased12
14Diarrhoea12
15Drug interaction12
16Chills11
17Condition aggravated11
18Pneumonia11
19Vomiting11
20Arthralgia11

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

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

Reason # of FDA Reports
1Gout126
2Hyperuricaemia104
3Product used for unknown indication65
4Gouty arthritis49
5Chronic myeloid leukaemia9
6Blood uric acid increased8
7Prophylaxis7
8Blood uric acid7
9Unevaluable event7
10Oedema peripheral6

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


Types of Adverse Events for ALOPRIM

Total Reports Filed with FDA: 1863


Number of FDA Adverse Event Reports by Patient Age for ALOPRIM

Total Reports Filed with FDA: 1863*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Allopurinol sodium (Aloprim, Allopurinol sodium)

Charts are based on 1863 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 ALOPRIM 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.