Tecfidera

N/A

Manufactured by Biogen Inc.

233,327 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Tecfidera

Tecfidera is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Biogen Inc.. The most commonly reported adverse reactions for Tecfidera include FLUSHING, NAUSEA, DIARRHOEA, MULTIPLE SCLEROSIS RELAPSE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Tecfidera.

Top Adverse Reactions

FLUSHING17,084 reports
NAUSEA8,965 reports
DIARRHOEA8,285 reports
MULTIPLE SCLEROSIS RELAPSE8,097 reports
FATIGUE6,952 reports
MULTIPLE SCLEROSIS5,723 reports
VOMITING5,647 reports
MEMORY IMPAIRMENT5,565 reports
GASTRIC DISORDER5,551 reports
ABDOMINAL PAIN UPPER5,407 reports
DRUG INEFFECTIVE5,215 reports
PRURITUS5,061 reports
HEADACHE5,034 reports
FALL5,019 reports
GAIT DISTURBANCE4,620 reports
MALAISE4,132 reports
ABDOMINAL DISCOMFORT3,625 reports
PAIN3,389 reports
DIZZINESS3,375 reports
ASTHENIA3,326 reports
HYPOAESTHESIA2,948 reports
BALANCE DISORDER2,773 reports
HOT FLUSH2,635 reports
PARAESTHESIA2,629 reports
RASH2,518 reports
ALOPECIA2,362 reports
URINARY TRACT INFECTION2,353 reports
GASTROINTESTINAL DISORDER2,270 reports
ABDOMINAL PAIN2,254 reports
DEPRESSION2,140 reports
ERYTHEMA2,128 reports
MUSCLE SPASMS2,125 reports
PAIN IN EXTREMITY2,009 reports
MUSCULAR WEAKNESS1,989 reports
MOBILITY DECREASED1,912 reports
FEELING ABNORMAL1,886 reports
DRUG DOSE OMISSION1,846 reports
CONSTIPATION1,842 reports
DYSPEPSIA1,800 reports
BURNING SENSATION1,770 reports
WHITE BLOOD CELL COUNT DECREASED1,767 reports
INSOMNIA1,747 reports
WEIGHT DECREASED1,729 reports
PRESCRIBED UNDERDOSE1,719 reports
URTICARIA1,711 reports
ANXIETY1,633 reports
COGNITIVE DISORDER1,633 reports
FEELING HOT1,603 reports
SEIZURE1,569 reports
VISUAL IMPAIRMENT1,556 reports
PYREXIA1,554 reports
CONFUSIONAL STATE1,548 reports
BACK PAIN1,542 reports
NASOPHARYNGITIS1,521 reports
STRESS1,489 reports
ABDOMINAL DISTENSION1,473 reports
DRUG INTOLERANCE1,461 reports
HYPERSENSITIVITY1,432 reports
DECREASED APPETITE1,390 reports
DEATH1,376 reports
DYSPNOEA1,363 reports
CENTRAL NERVOUS SYSTEM LESION1,360 reports
PRODUCT DOSE OMISSION ISSUE1,318 reports
TREMOR1,308 reports
PRODUCT DOSE OMISSION1,285 reports
UNDERDOSE1,275 reports
PNEUMONIA1,271 reports
ARTHRALGIA1,200 reports
GENERAL SYMPTOM1,156 reports
MATERNAL EXPOSURE DURING PREGNANCY1,100 reports
WEIGHT INCREASED1,091 reports
DEHYDRATION1,074 reports
LYMPHOCYTE COUNT DECREASED1,071 reports
INFLUENZA1,048 reports
INFLUENZA LIKE ILLNESS1,000 reports
FLATULENCE971 reports
MIGRAINE917 reports
VISION BLURRED907 reports
OFF LABEL USE903 reports
AMNESIA887 reports
HYPERHIDROSIS879 reports
COUGH871 reports
MUSCULOSKELETAL DISORDER839 reports
THERAPY CESSATION834 reports
CHEST PAIN817 reports
GASTROOESOPHAGEAL REFLUX DISEASE807 reports
HERPES ZOSTER800 reports
CONDITION AGGRAVATED792 reports
MUSCULOSKELETAL STIFFNESS764 reports
ADVERSE EVENT758 reports
SOMNOLENCE737 reports
PERIPHERAL SWELLING726 reports
SPEECH DISORDER715 reports
HYPERTENSION710 reports
CEREBROVASCULAR ACCIDENT709 reports
CHILLS698 reports
ADVERSE DRUG REACTION669 reports
COVID 19668 reports
RHINORRHOEA667 reports
ADVERSE REACTION648 reports

Report Outcomes

Out of 122,008 classified reports for Tecfidera:

  • Serious: 40,549 reports (33.2%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 81,459 reports (66.8%)
Serious 33.2%Non-Serious 66.8%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female90,323 (78.4%)
Male24,465 (21.2%)
Unknown477 (0.4%)

Reports by Age

Age 531,905 reports
Age 521,897 reports
Age 511,894 reports
Age 551,883 reports
Age 501,850 reports
Age 561,837 reports
Age 481,826 reports
Age 491,773 reports
Age 541,771 reports
Age 581,768 reports
Age 571,754 reports
Age 471,724 reports
Age 591,646 reports
Age 441,636 reports
Age 451,594 reports
Age 461,507 reports
Age 601,492 reports
Age 431,468 reports
Age 421,463 reports
Age 611,415 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Tecfidera?

This profile reflects 233,327 FDA FAERS reports that mention Tecfidera. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Tecfidera?

Frequently reported terms in FAERS include FLUSHING, NAUSEA, DIARRHOEA, MULTIPLE SCLEROSIS RELAPSE, FATIGUE, MULTIPLE SCLEROSIS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Tecfidera?

Labeling and FAERS entries often list Biogen Inc. in connection with Tecfidera. Always verify the specific product and NDC with your pharmacist.

Other Drugs by Biogen Inc.

Explore other medications manufactured by Biogen Inc. and compare their safety profiles:

DIMETHYL FUMARATE (55/100)DIROXIMEL FUMARATE (65/100)INTERFERON BETA 1A (72/100)NATALIZUMAB (72/100)

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Drugs Also Linked to FLUSHING

The following drugs share commonly reported adverse reactions with Tecfidera:

.ALPHA. TOCOPHEROL ACETATE, DL , ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D (35/100)CANDIDA ALBICANS (65/100)CARBOPROST TROMETHAMINE (82/100)CHEWABLE ASPIRIN (65/100)COLESEVELAM HYDROCHLORIDE (65/100)DALFAMPRIDINE (72/100)DIMETHYL FUMARATE (55/100)DIROXIMEL FUMARATE (65/100)EPOPROSTENOL SODIUM (85/100)FISH OIL (65/100)GLATIRAMER ACETATE (35/100)GLYBURIDE AND METFORMIN HYDROCHLORIDE (72/100)

View all drugs reporting FLUSHING →

Explore More

Safety RankingsSearch All DrugsCompare DrugsBiogen Inc. PortfolioFLUSHING in Other DrugsNAUSEA in Other DrugsDIARRHOEA in Other Drugs
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.