PHENYTOIN

N/A

Manufactured by Viatris Specialty LLC

36,996 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PHENYTOIN

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

Top Adverse Reactions

DRUG INEFFECTIVE2,670 reports
DRUG INTERACTION1,548 reports
SEIZURE1,382 reports
TOXICITY TO VARIOUS AGENTS1,353 reports
CONVULSION1,260 reports
OFF LABEL USE1,087 reports
STATUS EPILEPTICUS790 reports
STEVENS JOHNSON SYNDROME769 reports
PYREXIA682 reports
FALL609 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS600 reports
DIZZINESS598 reports
CONDITION AGGRAVATED555 reports
SOMNOLENCE537 reports
EPILEPSY526 reports
CONFUSIONAL STATE520 reports
VOMITING520 reports
HYPOTENSION519 reports
ATAXIA516 reports
NAUSEA511 reports
RASH509 reports
DRUG HYPERSENSITIVITY436 reports
FATIGUE432 reports
HEADACHE423 reports
GAIT DISTURBANCE387 reports
OVERDOSE381 reports
PNEUMONIA369 reports
DEATH365 reports
COMPLETED SUICIDE359 reports
NYSTAGMUS358 reports
MULTIPLE DRUG RESISTANCE357 reports
TOXIC EPIDERMAL NECROLYSIS337 reports
ASTHENIA329 reports
CARDIAC ARREST323 reports
LOSS OF CONSCIOUSNESS315 reports
SEPSIS315 reports
DIARRHOEA314 reports
TREMOR307 reports
DYSPNOEA306 reports
GENERALISED TONIC CLONIC SEIZURE303 reports
ANTICONVULSANT DRUG LEVEL INCREASED298 reports
THROMBOCYTOPENIA294 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION292 reports
DRUG RESISTANCE290 reports
PRODUCT USE IN UNAPPROVED INDICATION285 reports
FOETAL EXPOSURE DURING PREGNANCY282 reports
DYSARTHRIA268 reports
BALANCE DISORDER264 reports
DEPRESSED LEVEL OF CONSCIOUSNESS257 reports
PAIN251 reports
MALAISE246 reports
DRUG TOXICITY244 reports
GRAND MAL CONVULSION238 reports
ACUTE KIDNEY INJURY234 reports
TREATMENT FAILURE231 reports
ENCEPHALOPATHY226 reports
PARTIAL SEIZURES222 reports
RENAL FAILURE221 reports
COMA220 reports
TACHYCARDIA215 reports
AGITATION214 reports
DEPRESSION213 reports
RESPIRATORY FAILURE211 reports
MATERNAL EXPOSURE DURING PREGNANCY210 reports
MENTAL STATUS CHANGES209 reports
LETHARGY203 reports
PRURITUS201 reports
DRUG LEVEL DECREASED200 reports
ALANINE AMINOTRANSFERASE INCREASED198 reports
DRUG LEVEL INCREASED198 reports
NEUTROPENIA198 reports
MEMORY IMPAIRMENT196 reports
URINARY TRACT INFECTION192 reports
ANTICONVULSANT DRUG LEVEL DECREASED186 reports
ANAEMIA185 reports
ANXIETY182 reports
COGNITIVE DISORDER181 reports
DIPLOPIA181 reports
ASPARTATE AMINOTRANSFERASE INCREASED180 reports
HYPONATRAEMIA178 reports
METABOLIC ACIDOSIS177 reports
AGGRESSION176 reports
INSOMNIA175 reports
BRADYCARDIA174 reports
WEIGHT DECREASED171 reports
INFECTION170 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME168 reports
DYSPHAGIA167 reports
MEDICATION ERROR164 reports
HYPERTENSION157 reports
RASH MACULO PAPULAR157 reports
ABDOMINAL PAIN155 reports
DYSKINESIA155 reports
SEDATION155 reports
DECREASED APPETITE154 reports
HYPERSENSITIVITY153 reports
VISION BLURRED153 reports
BRAIN OEDEMA150 reports
INTENTIONAL OVERDOSE149 reports
FEELING ABNORMAL145 reports

Report Outcomes

Out of 20,447 classified reports for PHENYTOIN:

Serious 89.7%Non-Serious 10.3%

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

Male9,245 (51.5%)
Female8,568 (47.7%)
Unknown139 (0.8%)

Reports by Age

Age 54282 reports
Age 60268 reports
Age 61265 reports
Age 63262 reports
Age 58257 reports
Age 56251 reports
Age 59242 reports
Age 52239 reports
Age 65238 reports
Age 66231 reports
Age 48227 reports
Age 57226 reports
Age 30225 reports
Age 69224 reports
Age 70221 reports
Age 50202 reports
Age 36201 reports
Age 26200 reports
Age 55200 reports
Age 64200 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 PHENYTOIN?

This profile reflects 36,996 FDA FAERS reports that mention PHENYTOIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PHENYTOIN?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DRUG INTERACTION, SEIZURE, TOXICITY TO VARIOUS AGENTS, CONVULSION, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PHENYTOIN?

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