FINGOLIMOD

N/A

Manufactured by Apotex Corp.

6,602 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FINGOLIMOD

FINGOLIMOD is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Apotex Corp.. The most commonly reported adverse reactions for FINGOLIMOD include MULTIPLE SCLEROSIS RELAPSE, LYMPHOPENIA, MULTIPLE SCLEROSIS, DRUG INEFFECTIVE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FINGOLIMOD.

Top Adverse Reactions

MULTIPLE SCLEROSIS RELAPSE462 reports
LYMPHOPENIA394 reports
MULTIPLE SCLEROSIS263 reports
DRUG INEFFECTIVE228 reports
FATIGUE198 reports
COVID 19152 reports
OFF LABEL USE135 reports
HEADACHE134 reports
LYMPHOCYTE COUNT DECREASED134 reports
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY129 reports
DIZZINESS110 reports
HYPOAESTHESIA102 reports
REBOUND EFFECT95 reports
CONDITION AGGRAVATED93 reports
GAIT DISTURBANCE93 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME92 reports
EXPANDED DISABILITY STATUS SCALE SCORE INCREASED91 reports
PYREXIA87 reports
URINARY TRACT INFECTION76 reports
ASTHENIA75 reports
PAIN75 reports
DISEASE PROGRESSION74 reports
PARAESTHESIA73 reports
BREAST CANCER72 reports
CENTRAL NERVOUS SYSTEM LESION72 reports
NAUSEA72 reports
MALAISE71 reports
FALL66 reports
FOETAL EXPOSURE DURING PREGNANCY66 reports
HYPERTENSION64 reports
DISEASE RECURRENCE58 reports
MENINGITIS CRYPTOCOCCAL56 reports
HEMIPARESIS55 reports
MUSCULAR WEAKNESS55 reports
BASAL CELL CARCINOMA54 reports
CONFUSIONAL STATE54 reports
MACULAR OEDEMA54 reports
EXPOSURE DURING PREGNANCY52 reports
LEUKOPENIA52 reports
RELAPSING REMITTING MULTIPLE SCLEROSIS52 reports
WHITE BLOOD CELL COUNT DECREASED52 reports
BACK PAIN51 reports
DIARRHOEA51 reports
ALANINE AMINOTRANSFERASE INCREASED50 reports
PNEUMONIA49 reports
PRODUCT DOSE OMISSION ISSUE49 reports
VISUAL IMPAIRMENT48 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED47 reports
VISION BLURRED47 reports
BALANCE DISORDER46 reports
CRYPTOCOCCOSIS46 reports
DYSPNOEA46 reports
VOMITING46 reports
ABDOMINAL PAIN44 reports
DEATH43 reports
VACCINATION FAILURE43 reports
COUGH42 reports
NASOPHARYNGITIS42 reports
PRODUCT SUBSTITUTION ISSUE42 reports
ATAXIA41 reports
HERPES ZOSTER41 reports
PAIN IN EXTREMITY40 reports
PRODUCT USE IN UNAPPROVED INDICATION40 reports
DRUG INTOLERANCE39 reports
INFECTION39 reports
DECREASED IMMUNE RESPONSIVENESS37 reports
TREATMENT FAILURE36 reports
COGNITIVE DISORDER35 reports
MALIGNANT MELANOMA35 reports
OPTIC NEURITIS35 reports
FEELING ABNORMAL34 reports
IMMUNE THROMBOCYTOPENIA34 reports
TREMOR34 reports
BRADYCARDIA33 reports
HEPATIC ENZYME INCREASED33 reports
JC POLYOMAVIRUS TEST POSITIVE33 reports
MEMORY IMPAIRMENT32 reports
MYOCARDIAL INFARCTION32 reports
TUMEFACTIVE MULTIPLE SCLEROSIS32 reports
ASPARTATE AMINOTRANSFERASE INCREASED31 reports
CHEST PAIN31 reports
MATERNAL EXPOSURE DURING PREGNANCY31 reports
PALPITATIONS31 reports
PAPILLOMA VIRAL INFECTION31 reports
ALOPECIA30 reports
DEPRESSION30 reports
SENSORY DISTURBANCE30 reports
SKIN LESION30 reports
SOMNOLENCE30 reports
STRESS30 reports
SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS29 reports
CERVIX CARCINOMA28 reports
GASTROINTESTINAL DISORDER28 reports
PARAPARESIS28 reports
PRURITUS28 reports
WEIGHT DECREASED28 reports
WEIGHT INCREASED28 reports
ANXIETY27 reports
APHASIA27 reports
GENERAL PHYSICAL HEALTH DETERIORATION27 reports

Report Outcomes

Out of 4,082 classified reports for FINGOLIMOD:

Serious 84.4%Non-Serious 15.6%

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

Female2,582 (72.2%)
Male981 (27.4%)
Unknown13 (0.4%)

Reports by Age

Age 56110 reports
Age 51107 reports
Age 5099 reports
Age 4898 reports
Age 4189 reports
Age 4088 reports
Age 4688 reports
Age 4485 reports
Age 4283 reports
Age 3981 reports
Age 4980 reports
Age 5779 reports
Age 3772 reports
Age 6063 reports
Age 3262 reports
Age 4362 reports
Age 3561 reports
Age 5960 reports
Age 3159 reports
Age 4759 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 FINGOLIMOD?

This profile reflects 6,602 FDA FAERS reports that mention FINGOLIMOD. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FINGOLIMOD?

Frequently reported terms in FAERS include MULTIPLE SCLEROSIS RELAPSE, LYMPHOPENIA, MULTIPLE SCLEROSIS, DRUG INEFFECTIVE, FATIGUE, COVID-19. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FINGOLIMOD?

Labeling and FAERS entries often list Apotex Corp. in connection with FINGOLIMOD. 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.