SUMATRIPTAN SUCCINATE

N/A

Manufactured by Tonix Medicines, Inc.

47,922 FDA adverse event reports analyzed

Last updated: 2026-04-14

About SUMATRIPTAN SUCCINATE

SUMATRIPTAN SUCCINATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Tonix Medicines, Inc.. The most commonly reported adverse reactions for SUMATRIPTAN SUCCINATE include DRUG INEFFECTIVE, HEADACHE, MIGRAINE, NAUSEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SUMATRIPTAN SUCCINATE.

Top Adverse Reactions

DRUG INEFFECTIVE2,736 reports
HEADACHE2,047 reports
MIGRAINE1,773 reports
NAUSEA1,703 reports
FATIGUE1,439 reports
PAIN1,139 reports
DIZZINESS1,138 reports
OFF LABEL USE1,081 reports
PRODUCT DOSE OMISSION ISSUE947 reports
DYSPNOEA896 reports
VOMITING895 reports
DIARRHOEA818 reports
ANXIETY804 reports
ARTHRALGIA701 reports
PRODUCT QUALITY ISSUE696 reports
DEPRESSION671 reports
MALAISE671 reports
PARAESTHESIA553 reports
FEELING ABNORMAL550 reports
SOMNOLENCE542 reports
DRUG INTOLERANCE526 reports
PRURITUS520 reports
CONDITION AGGRAVATED513 reports
RASH508 reports
FALL503 reports
INJECTION SITE PAIN503 reports
INSOMNIA500 reports
ASTHENIA491 reports
HYPERSENSITIVITY489 reports
HYPERTENSION486 reports
CHEST PAIN477 reports
DEVICE ISSUE442 reports
HYPOAESTHESIA432 reports
ABDOMINAL PAIN429 reports
TREMOR417 reports
CHRONIC KIDNEY DISEASE412 reports
PRODUCT USE IN UNAPPROVED INDICATION412 reports
WEIGHT DECREASED411 reports
PAIN IN EXTREMITY404 reports
HYPERHIDROSIS401 reports
PYREXIA392 reports
DRUG HYPERSENSITIVITY390 reports
PNEUMONIA389 reports
CHEST DISCOMFORT370 reports
BACK PAIN367 reports
PRODUCT COMPLAINT361 reports
MUSCLE SPASMS355 reports
WEIGHT INCREASED349 reports
ASTHMA342 reports
CONSTIPATION341 reports
MYALGIA341 reports
PALPITATIONS336 reports
COUGH331 reports
CONFUSIONAL STATE330 reports
DRUG INTERACTION327 reports
MEMORY IMPAIRMENT322 reports
ABDOMINAL PAIN UPPER321 reports
ALOPECIA313 reports
DEVICE MALFUNCTION313 reports
SWELLING FACE312 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION305 reports
URINARY TRACT INFECTION304 reports
COVID 19297 reports
VISION BLURRED297 reports
FOETAL EXPOSURE DURING PREGNANCY294 reports
URTICARIA286 reports
SWOLLEN TONGUE284 reports
SINUSITIS280 reports
DECREASED APPETITE278 reports
SUICIDAL IDEATION278 reports
DEVICE DEPLOYMENT ISSUE276 reports
LOSS OF CONSCIOUSNESS268 reports
NASOPHARYNGITIS267 reports
BLOOD PRESSURE INCREASED265 reports
DYSPHONIA262 reports
ACUTE KIDNEY INJURY260 reports
ANGIOEDEMA256 reports
DRUG DOSE OMISSION250 reports
ABDOMINAL DISCOMFORT244 reports
NECK PAIN239 reports
GAIT DISTURBANCE238 reports
SEIZURE237 reports
HOT FLUSH236 reports
PSORIASIS235 reports
SEROTONIN SYNDROME234 reports
CONTUSION229 reports
THROAT TIGHTNESS229 reports
FLUSHING227 reports
GASTROOESOPHAGEAL REFLUX DISEASE226 reports
RENAL FAILURE225 reports
ILLNESS224 reports
HYPOTENSION217 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS217 reports
MATERNAL EXPOSURE DURING PREGNANCY216 reports
ARTHRITIS215 reports
PERIPHERAL SWELLING213 reports
ERYTHEMA210 reports
BRONCHITIS209 reports
MUSCULOSKELETAL STIFFNESS209 reports
EXPOSURE DURING PREGNANCY208 reports

Report Outcomes

Out of 23,879 classified reports for SUMATRIPTAN SUCCINATE:

Serious 58.5%Non-Serious 41.5%

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

Female17,740 (82.5%)
Male3,648 (17.0%)
Unknown109 (0.5%)

Reports by Age

Age 53468 reports
Age 41457 reports
Age 57378 reports
Age 47374 reports
Age 48352 reports
Age 59338 reports
Age 39337 reports
Age 51335 reports
Age 50333 reports
Age 54332 reports
Age 45329 reports
Age 55329 reports
Age 61322 reports
Age 52315 reports
Age 49305 reports
Age 56302 reports
Age 44288 reports
Age 46288 reports
Age 60274 reports
Age 43267 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 SUMATRIPTAN SUCCINATE?

This profile reflects 47,922 FDA FAERS reports that mention SUMATRIPTAN SUCCINATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SUMATRIPTAN SUCCINATE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, HEADACHE, MIGRAINE, NAUSEA, FATIGUE, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures SUMATRIPTAN SUCCINATE?

Labeling and FAERS entries often list Tonix Medicines, Inc. in connection with SUMATRIPTAN SUCCINATE. 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.