OZANIMOD HYDROCHLORIDE

N/A

Manufactured by Celgene Corporation

11,558 FDA adverse event reports analyzed

Last updated: 2026-04-14

About OZANIMOD HYDROCHLORIDE

OZANIMOD HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Celgene Corporation. The most commonly reported adverse reactions for OZANIMOD HYDROCHLORIDE include FATIGUE, MULTIPLE SCLEROSIS RELAPSE, DRUG INEFFECTIVE, HEADACHE, PRODUCT DOSE OMISSION ISSUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OZANIMOD HYDROCHLORIDE.

Top Adverse Reactions

FATIGUE721 reports
MULTIPLE SCLEROSIS RELAPSE573 reports
DRUG INEFFECTIVE535 reports
HEADACHE499 reports
PRODUCT DOSE OMISSION ISSUE337 reports
DIZZINESS332 reports
NAUSEA277 reports
DIARRHOEA256 reports
COLITIS ULCERATIVE246 reports
PAIN239 reports
BACK PAIN208 reports
ADVERSE EVENT183 reports
FALL174 reports
MULTIPLE SCLEROSIS170 reports
DYSPNOEA151 reports
HYPOAESTHESIA146 reports
ARTHRALGIA138 reports
HYPERTENSION136 reports
ASTHENIA133 reports
COVID 19130 reports
DEPRESSION129 reports
GAIT DISTURBANCE120 reports
PAIN IN EXTREMITY120 reports
RASH118 reports
URINARY TRACT INFECTION117 reports
VOMITING116 reports
OFF LABEL USE115 reports
PARAESTHESIA113 reports
PERIPHERAL SWELLING112 reports
BLOOD PRESSURE INCREASED110 reports
LYMPHOCYTE COUNT DECREASED110 reports
BALANCE DISORDER108 reports
WEIGHT DECREASED107 reports
WHITE BLOOD CELL COUNT DECREASED106 reports
MUSCLE SPASMS105 reports
ABDOMINAL PAIN UPPER104 reports
FEELING ABNORMAL103 reports
ABDOMINAL PAIN102 reports
VISUAL IMPAIRMENT101 reports
MEMORY IMPAIRMENT100 reports
WEIGHT INCREASED100 reports
ALOPECIA97 reports
CONDITION AGGRAVATED96 reports
INSOMNIA96 reports
MATERNAL EXPOSURE DURING PREGNANCY94 reports
MIGRAINE93 reports
NASOPHARYNGITIS92 reports
VISION BLURRED90 reports
PALPITATIONS84 reports
HEART RATE DECREASED83 reports
COUGH82 reports
LYMPHOPENIA82 reports
STRESS82 reports
DISTURBANCE IN ATTENTION81 reports
HEPATIC ENZYME INCREASED81 reports
MALAISE81 reports
ANXIETY80 reports
HAEMORRHAGE80 reports
HAEMATOCHEZIA79 reports
ILLNESS79 reports
HOSPITALISATION77 reports
PRURITUS74 reports
PYREXIA71 reports
CONSTIPATION67 reports
CHEST PAIN65 reports
DECREASED APPETITE64 reports
MUSCULOSKELETAL STIFFNESS62 reports
DEATH61 reports
MUSCULAR WEAKNESS61 reports
ABDOMINAL DISCOMFORT59 reports
CONFUSIONAL STATE59 reports
THERAPY INTERRUPTED59 reports
GENERAL PHYSICAL HEALTH DETERIORATION58 reports
UNEVALUABLE EVENT57 reports
SOMNOLENCE56 reports
TREATMENT NONCOMPLIANCE55 reports
TREMOR53 reports
HYPERSENSITIVITY49 reports
CONTUSION48 reports
THERAPY NON RESPONDER48 reports
GASTROINTESTINAL DISORDER46 reports
INFECTION46 reports
MYALGIA46 reports
CEREBROVASCULAR ACCIDENT45 reports
HEART RATE INCREASED45 reports
HERPES ZOSTER45 reports
RECTAL HAEMORRHAGE44 reports
SEIZURE42 reports
COLITIS41 reports
JOINT SWELLING41 reports
OROPHARYNGEAL PAIN40 reports
PRODUCT USE ISSUE40 reports
SLEEP DISORDER40 reports
ABDOMINAL DISTENSION39 reports
URINARY INCONTINENCE39 reports
FLATULENCE38 reports
HYPOTENSION37 reports
SINUSITIS37 reports
LIMB DISCOMFORT36 reports
PNEUMONIA36 reports

Report Outcomes

Out of 7,831 classified reports for OZANIMOD HYDROCHLORIDE:

Serious 26.8%Non-Serious 73.2%

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

Female5,327 (71.2%)
Male2,153 (28.8%)
Unknown5 (0.1%)

Reports by Age

Age 49177 reports
Age 56167 reports
Age 55162 reports
Age 57162 reports
Age 43160 reports
Age 50160 reports
Age 63160 reports
Age 46159 reports
Age 44156 reports
Age 51155 reports
Age 45154 reports
Age 53154 reports
Age 54153 reports
Age 48152 reports
Age 41148 reports
Age 42148 reports
Age 60140 reports
Age 62138 reports
Age 52137 reports
Age 58134 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 OZANIMOD HYDROCHLORIDE?

This profile reflects 11,558 FDA FAERS reports that mention OZANIMOD HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OZANIMOD HYDROCHLORIDE?

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

Who manufactures OZANIMOD HYDROCHLORIDE?

Labeling and FAERS entries often list Celgene Corporation in connection with OZANIMOD 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.