EXTENDED PHENYTOIN SODIUM

N/A

Manufactured by Viatris Specialty LLC

34,830 FDA adverse event reports analyzed

Last updated: 2026-04-14

About EXTENDED PHENYTOIN SODIUM

EXTENDED PHENYTOIN SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. The most commonly reported adverse reactions for EXTENDED PHENYTOIN SODIUM include CONVULSION, SEIZURE, DRUG INEFFECTIVE, FALL, DRUG HYPERSENSITIVITY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EXTENDED PHENYTOIN SODIUM.

Top Adverse Reactions

CONVULSION2,172 reports
SEIZURE1,409 reports
DRUG INEFFECTIVE1,271 reports
FALL909 reports
DRUG HYPERSENSITIVITY851 reports
DIZZINESS843 reports
HEADACHE826 reports
FATIGUE803 reports
NAUSEA702 reports
PAIN578 reports
ASTHENIA568 reports
RASH554 reports
VOMITING536 reports
WEIGHT DECREASED511 reports
SOMNOLENCE485 reports
DRUG INTERACTION467 reports
STEVENS JOHNSON SYNDROME467 reports
GAIT DISTURBANCE466 reports
CONFUSIONAL STATE465 reports
MALAISE461 reports
TREMOR460 reports
DEPRESSION446 reports
OFF LABEL USE446 reports
FEELING ABNORMAL437 reports
DYSPNOEA436 reports
BALANCE DISORDER417 reports
DIARRHOEA416 reports
DEATH410 reports
CONDITION AGGRAVATED388 reports
ANXIETY385 reports
PYREXIA385 reports
INSOMNIA379 reports
CEREBROVASCULAR ACCIDENT373 reports
PNEUMONIA371 reports
ANTICONVULSANT DRUG LEVEL DECREASED368 reports
MEMORY IMPAIRMENT360 reports
GRAND MAL CONVULSION327 reports
PRURITUS324 reports
ANTICONVULSANT DRUG LEVEL INCREASED315 reports
WEIGHT INCREASED312 reports
TOXICITY TO VARIOUS AGENTS307 reports
AMNESIA304 reports
HYPERTENSION298 reports
PAIN IN EXTREMITY294 reports
LOSS OF CONSCIOUSNESS293 reports
PHARMACEUTICAL PRODUCT COMPLAINT292 reports
HYPOAESTHESIA265 reports
ARTHRALGIA261 reports
DRUG LEVEL DECREASED251 reports
GENERALISED TONIC CLONIC SEIZURE250 reports
CONSTIPATION244 reports
CHEST PAIN243 reports
MUSCULAR WEAKNESS235 reports
DECREASED APPETITE224 reports
BACK PAIN220 reports
COUGH219 reports
DYSARTHRIA212 reports
BLOOD PRESSURE INCREASED211 reports
VISION BLURRED208 reports
URINARY TRACT INFECTION206 reports
DYSPHAGIA205 reports
HYPERSENSITIVITY205 reports
SPEECH DISORDER201 reports
LETHARGY200 reports
OEDEMA PERIPHERAL200 reports
MYOCARDIAL INFARCTION199 reports
OVERDOSE198 reports
HYPOTENSION192 reports
DEHYDRATION190 reports
NEUROPATHY PERIPHERAL185 reports
RENAL FAILURE184 reports
ABDOMINAL PAIN182 reports
PARAESTHESIA178 reports
MUSCLE SPASMS176 reports
EPILEPSY175 reports
URTICARIA175 reports
ANAEMIA173 reports
STRESS172 reports
DRUG LEVEL INCREASED171 reports
ABDOMINAL PAIN UPPER169 reports
ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC161 reports
VISUAL IMPAIRMENT159 reports
ATAXIA158 reports
DIABETES MELLITUS158 reports
MENTAL STATUS CHANGES158 reports
SUICIDAL IDEATION156 reports
COORDINATION ABNORMAL154 reports
DRUG TOXICITY153 reports
DRUG DOSE OMISSION152 reports
INJURY150 reports
NASOPHARYNGITIS150 reports
DEEP VEIN THROMBOSIS147 reports
CONTUSION145 reports
HEAD INJURY140 reports
OSTEOPOROSIS140 reports
COMA138 reports
AGITATION137 reports
DISEASE PROGRESSION137 reports
ROAD TRAFFIC ACCIDENT136 reports
BLOOD GLUCOSE INCREASED135 reports

Report Outcomes

Out of 16,545 classified reports for EXTENDED PHENYTOIN SODIUM:

Serious 71.6%Non-Serious 28.4%

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

Female8,610 (55.7%)
Male6,760 (43.7%)
Unknown91 (0.6%)

Reports by Age

Age 56234 reports
Age 54232 reports
Age 63228 reports
Age 58226 reports
Age 65225 reports
Age 57222 reports
Age 59222 reports
Age 60221 reports
Age 55219 reports
Age 61214 reports
Age 50205 reports
Age 64205 reports
Age 71203 reports
Age 52202 reports
Age 62202 reports
Age 51200 reports
Age 68196 reports
Age 66195 reports
Age 48187 reports
Age 49180 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 EXTENDED PHENYTOIN SODIUM?

This profile reflects 34,830 FDA FAERS reports that mention EXTENDED PHENYTOIN SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for EXTENDED PHENYTOIN SODIUM?

Frequently reported terms in FAERS include CONVULSION, SEIZURE, DRUG INEFFECTIVE, FALL, DRUG HYPERSENSITIVITY, DIZZINESS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures EXTENDED PHENYTOIN SODIUM?

Labeling and FAERS entries often list Viatris Specialty LLC in connection with EXTENDED PHENYTOIN SODIUM. 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.