SIPONIMOD

N/A

Manufactured by Novartis Pharmaceuticals Corporation

19,111 FDA adverse event reports analyzed

Last updated: 2026-04-14

About SIPONIMOD

SIPONIMOD is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. The most commonly reported adverse reactions for SIPONIMOD include FATIGUE, HEADACHE, DIZZINESS, GAIT DISTURBANCE, MULTIPLE SCLEROSIS RELAPSE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SIPONIMOD.

Top Adverse Reactions

FATIGUE980 reports
HEADACHE877 reports
DIZZINESS664 reports
GAIT DISTURBANCE527 reports
MULTIPLE SCLEROSIS RELAPSE521 reports
FALL496 reports
MULTIPLE SCLEROSIS475 reports
DRUG INEFFECTIVE415 reports
NAUSEA406 reports
LYMPHOCYTE COUNT DECREASED403 reports
PRODUCT DOSE OMISSION ISSUE389 reports
COVID 19364 reports
URINARY TRACT INFECTION364 reports
ASTHENIA349 reports
PAIN335 reports
HYPOAESTHESIA306 reports
BALANCE DISORDER304 reports
MALAISE304 reports
MEMORY IMPAIRMENT303 reports
FEELING ABNORMAL290 reports
HYPERTENSION282 reports
WHITE BLOOD CELL COUNT DECREASED270 reports
VISUAL IMPAIRMENT266 reports
PAIN IN EXTREMITY249 reports
HEART RATE DECREASED240 reports
MUSCULAR WEAKNESS237 reports
PERIPHERAL SWELLING237 reports
DYSPNOEA235 reports
LYMPHOPENIA221 reports
VISION BLURRED219 reports
DIARRHOEA200 reports
MOBILITY DECREASED193 reports
TREMOR184 reports
SOMNOLENCE183 reports
PYREXIA172 reports
BLOOD PRESSURE INCREASED169 reports
VOMITING160 reports
CONDITION AGGRAVATED159 reports
PARAESTHESIA157 reports
INSOMNIA147 reports
BACK PAIN146 reports
ANXIETY143 reports
SEIZURE142 reports
MIGRAINE139 reports
COUGH138 reports
ARTHRALGIA136 reports
CONFUSIONAL STATE135 reports
DEATH135 reports
MUSCLE SPASMS134 reports
ABDOMINAL DISCOMFORT132 reports
NASOPHARYNGITIS131 reports
HEPATIC ENZYME INCREASED130 reports
LIMB DISCOMFORT128 reports
RASH125 reports
ILLNESS118 reports
MUSCULOSKELETAL STIFFNESS113 reports
MOVEMENT DISORDER111 reports
CHEST PAIN110 reports
DEPRESSION107 reports
CENTRAL NERVOUS SYSTEM LESION105 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION105 reports
ALOPECIA99 reports
PRODUCT USE IN UNAPPROVED INDICATION99 reports
INFECTION98 reports
COGNITIVE DISORDER97 reports
PNEUMONIA96 reports
MUSCLE SPASTICITY93 reports
PALPITATIONS93 reports
CONTUSION92 reports
DYSARTHRIA92 reports
BASAL CELL CARCINOMA90 reports
CEREBROVASCULAR ACCIDENT89 reports
BRADYCARDIA88 reports
OEDEMA PERIPHERAL88 reports
CONSTIPATION86 reports
WEIGHT INCREASED86 reports
JOINT SWELLING85 reports
SPEECH DISORDER85 reports
OFF LABEL USE84 reports
DECREASED APPETITE83 reports
GENERAL PHYSICAL HEALTH DETERIORATION82 reports
INCORRECT DOSE ADMINISTERED81 reports
STRESS81 reports
WEIGHT DECREASED80 reports
ABDOMINAL PAIN UPPER78 reports
HYPERSENSITIVITY78 reports
PRURITUS78 reports
GAIT INABILITY76 reports
EXPANDED DISABILITY STATUS SCALE SCORE INCREASED75 reports
LEUKOPENIA75 reports
HYPOTENSION74 reports
PRODUCT DOSE OMISSION72 reports
VERTIGO72 reports
CHEST DISCOMFORT70 reports
POLLAKIURIA70 reports
HERPES ZOSTER68 reports
EYE PAIN66 reports
MACULAR OEDEMA66 reports
SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS66 reports
AMNESIA65 reports

Report Outcomes

Out of 8,710 classified reports for SIPONIMOD:

Serious 49.3%Non-Serious 50.7%

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

Female6,103 (75.0%)
Male2,030 (25.0%)
Unknown1 (0.0%)

Reports by Age

Age 60153 reports
Age 56151 reports
Age 59148 reports
Age 62148 reports
Age 50147 reports
Age 54143 reports
Age 58143 reports
Age 57142 reports
Age 61136 reports
Age 51135 reports
Age 63131 reports
Age 53119 reports
Age 52116 reports
Age 64116 reports
Age 48115 reports
Age 49112 reports
Age 55110 reports
Age 47102 reports
Age 6688 reports
Age 4177 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 SIPONIMOD?

This profile reflects 19,111 FDA FAERS reports that mention SIPONIMOD. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SIPONIMOD?

Frequently reported terms in FAERS include FATIGUE, HEADACHE, DIZZINESS, GAIT DISTURBANCE, MULTIPLE SCLEROSIS RELAPSE, FALL. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures SIPONIMOD?

Labeling and FAERS entries often list Novartis Pharmaceuticals Corporation in connection with SIPONIMOD. 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.