Drug Safety Information for ARALEN (Chloroquine phosphate)

Safety-related Labeling Changes for ARALEN (CHLOROQUINE PHOSPHATE) Brand name discontinued; available as generic: FDA Link

Adverse Drug Reactions for ARALEN* (Chloroquine phosphate)

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 ARALEN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain78
2Arthralgia77
3Vomiting66
4Drug ineffective63
5Pyrexia62
6Pneumonia61
7Headache59
8Nausea57
9Dyspnoea51
10Dizziness49
11Asthenia47
12Fatigue46
13Malaise46
14Pain in extremity44
15Weight decreased41
16Anaemia40
17Atrioventricular block complete40
18Toxicity to various agents39
19Diarrhoea*38
20Rheumatoid arthritis37

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

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

Reason # of FDA Reports
1Rheumatoid arthritis1143
2Product used for unknown indication1062
3Systemic lupus erythematosus315
4Malaria prophylaxis*249
5Cutaneous lupus erythematosus195
6Malaria178
7Prophylaxis85
8Arthritis59
9Pyrexia56
10Arthralgia52

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


Types of Adverse Events for ARALEN

Total Reports Filed with FDA: 6524


Number of FDA Adverse Event Reports by Patient Age for ARALEN

Total Reports Filed with FDA: 6524*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Chloroquine phosphate (Aralen, Resochin, Chloroquine)

Charts are based on 6524 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 ARALEN 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.