DIROXIMEL FUMARATE

N/A

Manufactured by Biogen Inc.

25,327 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DIROXIMEL FUMARATE

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

Top Adverse Reactions

FLUSHING1,560 reports
MULTIPLE SCLEROSIS1,023 reports
MULTIPLE SCLEROSIS RELAPSE935 reports
DIARRHOEA852 reports
PRODUCT DOSE OMISSION ISSUE785 reports
FATIGUE745 reports
NAUSEA729 reports
HEADACHE585 reports
PRURITUS573 reports
MEMORY IMPAIRMENT532 reports
FALL520 reports
ABDOMINAL DISCOMFORT504 reports
PRODUCT DOSE OMISSION IN ERROR493 reports
DRUG INEFFECTIVE489 reports
ABDOMINAL PAIN UPPER458 reports
HOT FLUSH455 reports
GASTROINTESTINAL DISORDER397 reports
DIZZINESS394 reports
WHITE BLOOD CELL COUNT DECREASED359 reports
GAIT DISTURBANCE347 reports
PAIN347 reports
COVID 19342 reports
VOMITING322 reports
MALAISE300 reports
HYPOAESTHESIA291 reports
BALANCE DISORDER288 reports
ASTHENIA282 reports
PARAESTHESIA274 reports
RASH259 reports
DYSPEPSIA256 reports
DEATH251 reports
HYPERSENSITIVITY251 reports
URINARY TRACT INFECTION249 reports
CONSTIPATION248 reports
LYMPHOCYTE COUNT DECREASED247 reports
COGNITIVE DISORDER224 reports
PAIN IN EXTREMITY223 reports
ILLNESS218 reports
FEELING ABNORMAL211 reports
MUSCULAR WEAKNESS198 reports
GASTRIC DISORDER195 reports
MUSCLE SPASMS194 reports
VISUAL IMPAIRMENT194 reports
INTENTIONAL PRODUCT MISUSE192 reports
STRESS182 reports
SEIZURE177 reports
ANXIETY176 reports
DEPRESSION176 reports
MOBILITY DECREASED170 reports
FEELING HOT169 reports
URTICARIA163 reports
CONFUSIONAL STATE162 reports
NASOPHARYNGITIS162 reports
TREMOR162 reports
ERYTHEMA159 reports
ABDOMINAL PAIN153 reports
UNDERDOSE146 reports
INSOMNIA145 reports
BACK PAIN141 reports
WEIGHT DECREASED139 reports
PNEUMONIA135 reports
CEREBROVASCULAR ACCIDENT133 reports
ARTHRALGIA131 reports
ABDOMINAL DISTENSION130 reports
ALOPECIA128 reports
FLATULENCE124 reports
DECREASED APPETITE123 reports
DIABETES MELLITUS122 reports
GAIT INABILITY120 reports
GASTROOESOPHAGEAL REFLUX DISEASE120 reports
MIGRAINE118 reports
FULL BLOOD COUNT DECREASED115 reports
DYSPNOEA113 reports
DRUG INTOLERANCE110 reports
SOMNOLENCE108 reports
BURNING SENSATION107 reports
PRESCRIBED UNDERDOSE106 reports
CENTRAL NERVOUS SYSTEM LESION104 reports
MUSCULOSKELETAL DISORDER102 reports
PERIPHERAL SWELLING102 reports
VISION BLURRED95 reports
INFLUENZA94 reports
RASH PRURITIC93 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION87 reports
MUSCULOSKELETAL STIFFNESS87 reports
BREAST CANCER FEMALE84 reports
CONDITION AGGRAVATED84 reports
WEIGHT INCREASED84 reports
DYSPHAGIA81 reports
VERTIGO79 reports
COUGH77 reports
HYPERTENSION77 reports
HERPES ZOSTER76 reports
CHROMATURIA75 reports
MOTOR DYSFUNCTION75 reports
RHINORRHOEA75 reports
BLINDNESS73 reports
CHEST PAIN70 reports
SPEECH DISORDER70 reports
MENTAL IMPAIRMENT67 reports

Report Outcomes

Out of 11,105 classified reports for DIROXIMEL FUMARATE:

Serious 39.2%Non-Serious 60.8%

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

Female8,657 (78.9%)
Male2,316 (21.1%)
Unknown6 (0.1%)

Reports by Age

Age 59136 reports
Age 60129 reports
Age 61129 reports
Age 56125 reports
Age 63124 reports
Age 55123 reports
Age 57119 reports
Age 62118 reports
Age 53117 reports
Age 58115 reports
Age 50112 reports
Age 54111 reports
Age 64109 reports
Age 47107 reports
Age 52107 reports
Age 51104 reports
Age 65100 reports
Age 4998 reports
Age 4597 reports
Age 6794 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 DIROXIMEL FUMARATE?

This profile reflects 25,327 FDA FAERS reports that mention DIROXIMEL FUMARATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DIROXIMEL FUMARATE?

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

Who manufactures DIROXIMEL FUMARATE?

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

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.