Drug Safety Information for FOLIC ACID (Folic acid)

Adverse Drug Reactions for FOLIC ACID* (Folic acid)

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 FOLIC ACID
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fatigue4293
2Nausea4276
3Drug ineffective4072
4Injection site pain4064
5Arthralgia3891
6Pain3761
7Dyspnoea3698
8Headache3589
9Diarrhoea3361
10Pyrexia3040
11Pneumonia2955
12Vomiting2813
13Dizziness2594
14Pain in extremity2591
15Asthenia2562
16Fall2476
17Anaemia2277
18Cough2139
19Rash2138
20Rheumatoid arthritis2117

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

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

Reason # of FDA Reports
1Product used for unknown indication73979
2Vitamin supplementation16589
3Rheumatoid arthritis11759
4Prophylaxis5427
5Supplementation therapy3671
6Anaemia2625
7Prophylaxis of neural tube defect1423
8Folate deficiency1207
9Psoriatic arthropathy1133
10Paroxysmal nocturnal haemoglobinuria1076

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


Types of Adverse Events for FOLIC ACID

Total Reports Filed with FDA: 368394


Number of FDA Adverse Event Reports by Patient Age for FOLIC ACID

Total Reports Filed with FDA: 368394*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Folic acid (Folicet, Folates, Folacin, Folvite, Folate, Folic acid)

Charts are based on 368394 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 FOLIC ACID 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.