FINGOLIMOD HYDROCHLORIDE

N/A

Manufactured by Ascend Laboratories, LLC

8,208 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FINGOLIMOD HYDROCHLORIDE

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

Top Adverse Reactions

MULTIPLE SCLEROSIS RELAPSE554 reports
LYMPHOPENIA418 reports
MULTIPLE SCLEROSIS309 reports
FATIGUE280 reports
DRUG INEFFECTIVE256 reports
HEADACHE185 reports
LYMPHOCYTE COUNT DECREASED176 reports
COVID 19163 reports
DIZZINESS155 reports
HYPOAESTHESIA151 reports
GAIT DISTURBANCE149 reports
OFF LABEL USE147 reports
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY139 reports
PAIN124 reports
CONDITION AGGRAVATED115 reports
EXPANDED DISABILITY STATUS SCALE SCORE INCREASED109 reports
PYREXIA107 reports
NAUSEA105 reports
MALAISE104 reports
PARAESTHESIA102 reports
ASTHENIA100 reports
FALL97 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME97 reports
REBOUND EFFECT96 reports
URINARY TRACT INFECTION94 reports
CENTRAL NERVOUS SYSTEM LESION89 reports
MUSCULAR WEAKNESS86 reports
HYPERTENSION79 reports
BREAST CANCER77 reports
DISEASE PROGRESSION77 reports
VISUAL IMPAIRMENT77 reports
BACK PAIN73 reports
DIARRHOEA71 reports
CONFUSIONAL STATE70 reports
BALANCE DISORDER68 reports
PRODUCT DOSE OMISSION ISSUE68 reports
WHITE BLOOD CELL COUNT DECREASED67 reports
FOETAL EXPOSURE DURING PREGNANCY66 reports
MACULAR OEDEMA66 reports
PAIN IN EXTREMITY65 reports
VISION BLURRED65 reports
DYSPNOEA63 reports
HEMIPARESIS62 reports
ABDOMINAL PAIN60 reports
MENINGITIS CRYPTOCOCCAL60 reports
PNEUMONIA60 reports
DISEASE RECURRENCE59 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED58 reports
LEUKOPENIA58 reports
RELAPSING REMITTING MULTIPLE SCLEROSIS58 reports
VOMITING58 reports
COUGH57 reports
BASAL CELL CARCINOMA56 reports
FEELING ABNORMAL55 reports
MEMORY IMPAIRMENT55 reports
ALANINE AMINOTRANSFERASE INCREASED54 reports
EXPOSURE DURING PREGNANCY52 reports
ATAXIA51 reports
SOMNOLENCE50 reports
CHEST PAIN49 reports
DRUG INTOLERANCE49 reports
HERPES ZOSTER49 reports
DEATH48 reports
OPTIC NEURITIS48 reports
CRYPTOCOCCOSIS47 reports
STRESS47 reports
BRADYCARDIA46 reports
NASOPHARYNGITIS46 reports
PRODUCT USE IN UNAPPROVED INDICATION46 reports
TREMOR46 reports
INSOMNIA45 reports
VACCINATION FAILURE45 reports
HEPATIC ENZYME INCREASED44 reports
PRODUCT SUBSTITUTION ISSUE44 reports
PALPITATIONS43 reports
TREATMENT FAILURE43 reports
COGNITIVE DISORDER42 reports
DECREASED APPETITE42 reports
DECREASED IMMUNE RESPONSIVENESS42 reports
INFECTION42 reports
SENSORY DISTURBANCE42 reports
ALOPECIA41 reports
ANXIETY38 reports
MATERNAL EXPOSURE DURING PREGNANCY38 reports
WEIGHT INCREASED38 reports
ARTHRALGIA37 reports
DEPRESSION37 reports
IMMUNE THROMBOCYTOPENIA37 reports
WEIGHT DECREASED37 reports
CHILLS36 reports
GENERAL PHYSICAL HEALTH DETERIORATION36 reports
IMMUNODEFICIENCY36 reports
MYOCARDIAL INFARCTION36 reports
SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS36 reports
APHASIA35 reports
HYPOTENSION35 reports
MALIGNANT MELANOMA35 reports
MUSCLE SPASMS35 reports
ABDOMINAL DISCOMFORT34 reports
ASPARTATE AMINOTRANSFERASE INCREASED34 reports

Report Outcomes

Out of 4,544 classified reports for FINGOLIMOD HYDROCHLORIDE:

Serious 85.6%Non-Serious 14.4%

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

Female2,893 (72.7%)
Male1,073 (27.0%)
Unknown13 (0.3%)

Reports by Age

Age 51120 reports
Age 56112 reports
Age 50109 reports
Age 48107 reports
Age 41103 reports
Age 40102 reports
Age 4299 reports
Age 4696 reports
Age 4493 reports
Age 3992 reports
Age 4991 reports
Age 5788 reports
Age 3784 reports
Age 5569 reports
Age 3268 reports
Age 4367 reports
Age 6067 reports
Age 4766 reports
Age 5366 reports
Age 3565 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 HYDROCHLORIDE?

This profile reflects 8,208 FDA FAERS reports that mention FINGOLIMOD HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FINGOLIMOD HYDROCHLORIDE?

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

Who manufactures FINGOLIMOD HYDROCHLORIDE?

Labeling and FAERS entries often list Ascend Laboratories, LLC in connection with FINGOLIMOD HYDROCHLORIDE. 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.