Drug Safety Information for TECFIDERA (Dimethyl fumarate)
FDA Safety-related Labeling Changes for TECFIDERA (DIMETHYL FUMARATE) Rx Drug: Safety Information Link
Serious herpes zoster infection Safety label updated
Required post-approval safety study:
A large, long-term, prospective observational study in adult patients with relapsing multiple sclerosis, with the primary objective of determining the nature and incidence of serious infections including opportunistic infections, leiomyomata, malignancies including renal cell cancers, and other serious adverse events including serious renal and hepatic events and other medically significant events occurring with marketed use of Tecfidera (dimethyl fumarate). The study should include characterization of the finding of urinary ketones. A minimum of 5000 multiple sclerosis patients treated with Tecfidera (dimethyl fumarate) should be enrolled and followed for a minimum of 5 years. The final protocol should reflect agency agreement and be submitted prior to starting the study. Due Date: 2023-10-30
Required post-approval safety study:
Deferred pediatric trial under PREA: A randomized, controlled, parallel group superiority trial in pediatric patients ages 10 through 17 years to evaluate the pharmacokinetics of dimethyl fumarate, and the safety and efficacy of dimethyl fumarate compared to an appropriate control for the treatment of relapsing forms of multiple sclerosis. Due Date: 2020-02-28
Original FDA Drug Approval Date for TECFIDERA: 2013-03-27
Adverse Drug Reactions for TECFIDERA* (Dimethyl fumarate)
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 TECFIDERA
(reported in FDA Medwatch/FAERS Reports)
| Side Effect | # of FDA Reports | |
|---|---|---|
| 1 | Flushing | 8160 |
| 2 | Nausea | 5042 |
| 3 | Diarrhoea | 4388 |
| 4 | Vomiting | 3120 |
| 5 | Abdominal pain upper | 2912 |
| 6 | Fatigue | 2558 |
| 7 | Pruritus | 2442 |
| 8 | Headache | 2116 |
| 9 | Multiple sclerosis relapse | 1698 |
| 10 | Abdominal discomfort | 1541 |
| 11 | Memory impairment | 1397 |
| 12 | Malaise | 1348 |
| 13 | Gait disturbance | 1338 |
| 14 | Asthenia | 1318 |
| 15 | Dizziness | 1293 |
| 16 | Rash | 1247 |
| 17 | Abdominal pain | 1132 |
| 18 | Erythema | 1114 |
| 19 | Pain | 1111 |
| 20 | Gastric disorder | 1098 |
* This side effect also appears in "Top 10 Side Effects of TECFIDERA " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking TECFIDERA
(associated with FDA Medwatch/FAERS Reports)
| Reason | # of FDA Reports | |
|---|---|---|
| 1 | Multiple sclerosis | 89930 |
| 2 | Product used for unknown indication | 12170 |
| 3 | Relapsing-remitting multiple sclerosis | 10196 |
| 4 | Secondary progressive multiple sclerosis | 52 |
| 5 | Multiple sclerosis relapse | 44 |
| 6 | Drug therapy | 16 |
| 7 | Maternal exposure timing unspecified | 15 |
| 8 | Psoriasis | 14 |
| 9 | Pruritus | 11 |
| 10 | Multiple sclerosis relapse prophylaxis | 10 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for TECFIDERA
Total Reports Filed with FDA: 114193
Number of FDA Adverse Event Reports by Patient Age for TECFIDERA
Total Reports Filed with FDA: 114193*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dimethyl fumarate (Tecfidera)
Charts are based on 114193 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.
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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.