PHENYTOIN SODIUM

N/A

Manufactured by Mylan Pharmaceuticals Inc.

6,984 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PHENYTOIN SODIUM

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

Top Adverse Reactions

DRUG INEFFECTIVE620 reports
SEIZURE351 reports
CONVULSION288 reports
DRUG INTERACTION258 reports
TOXICITY TO VARIOUS AGENTS233 reports
DIZZINESS140 reports
FALL139 reports
EPILEPSY123 reports
OFF LABEL USE123 reports
PYREXIA121 reports
HEADACHE113 reports
HYPOTENSION112 reports
ATAXIA109 reports
DRUG HYPERSENSITIVITY109 reports
SOMNOLENCE100 reports
CONFUSIONAL STATE98 reports
STATUS EPILEPTICUS97 reports
NAUSEA95 reports
CONDITION AGGRAVATED93 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS90 reports
RASH89 reports
VOMITING87 reports
ANTICONVULSANT DRUG LEVEL DECREASED86 reports
FATIGUE85 reports
GAIT DISTURBANCE83 reports
STEVENS JOHNSON SYNDROME79 reports
BALANCE DISORDER73 reports
TREMOR73 reports
ANTICONVULSANT DRUG LEVEL INCREASED70 reports
DRUG LEVEL DECREASED70 reports
ASTHENIA67 reports
MALAISE64 reports
NYSTAGMUS64 reports
PHARMACEUTICAL PRODUCT COMPLAINT64 reports
DYSARTHRIA63 reports
GRAND MAL CONVULSION61 reports
ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC59 reports
DEATH58 reports
PAIN58 reports
BRADYCARDIA57 reports
FEELING ABNORMAL57 reports
DYSPNOEA55 reports
CARDIAC ARREST53 reports
PNEUMONIA53 reports
DIARRHOEA52 reports
LOSS OF CONSCIOUSNESS51 reports
MEMORY IMPAIRMENT51 reports
WEIGHT DECREASED49 reports
DRUG INTOLERANCE48 reports
PRODUCT SUBSTITUTION ISSUE48 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION47 reports
TOXIC EPIDERMAL NECROLYSIS47 reports
PRURITUS46 reports
NEUROPATHY PERIPHERAL45 reports
GENERALISED TONIC CLONIC SEIZURE44 reports
INSOMNIA44 reports
URINARY TRACT INFECTION43 reports
DRUG TOXICITY41 reports
DEPRESSION40 reports
DRUG LEVEL INCREASED40 reports
OVERDOSE39 reports
CEREBROVASCULAR ACCIDENT38 reports
ANXIETY36 reports
COUGH36 reports
DYSKINESIA35 reports
ERYTHEMA35 reports
HYPOAESTHESIA35 reports
RENAL FAILURE35 reports
HYPERHIDROSIS33 reports
HYPERSENSITIVITY33 reports
MUSCULAR WEAKNESS33 reports
AGGRESSION32 reports
SEPSIS32 reports
ANTICONVULSANT DRUG LEVEL ABOVE THERAPEUTIC31 reports
ARTHRALGIA31 reports
DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS31 reports
AMNESIA30 reports
ANAEMIA30 reports
COMA30 reports
HEAD INJURY30 reports
SPEECH DISORDER30 reports
CONSTIPATION29 reports
HALLUCINATION29 reports
RESPIRATORY FAILURE29 reports
ACUTE KIDNEY INJURY28 reports
LETHARGY28 reports
MEDICATION ERROR28 reports
PURPLE GLOVE SYNDROME28 reports
AGITATION27 reports
DEPRESSED LEVEL OF CONSCIOUSNESS27 reports
DIPLOPIA27 reports
PAIN IN EXTREMITY27 reports
TREATMENT NONCOMPLIANCE27 reports
CEREBELLAR ATROPHY26 reports
ERYTHEMA MULTIFORME26 reports
TACHYCARDIA26 reports
VISION BLURRED26 reports
ALOPECIA25 reports
DEEP VEIN THROMBOSIS25 reports
DRUG LEVEL FLUCTUATING25 reports

Report Outcomes

Out of 3,940 classified reports for PHENYTOIN SODIUM:

Serious 82.7%Non-Serious 17.3%

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

Female1,825 (51.0%)
Male1,727 (48.3%)
Unknown25 (0.7%)

Reports by Age

Age 6569 reports
Age 7068 reports
Age 6063 reports
Age 6461 reports
Age 5957 reports
Age 6357 reports
Age 5156 reports
Age 5553 reports
Age 5853 reports
Age 6253 reports
Age 4952 reports
Age 5452 reports
Age 6152 reports
Age 7252 reports
Age 6751 reports
Age 5249 reports
Age 5649 reports
Age 6849 reports
Age 7149 reports
Age 5048 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 SODIUM?

This profile reflects 6,984 FDA FAERS reports that mention PHENYTOIN SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PHENYTOIN SODIUM?

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

Who manufactures PHENYTOIN SODIUM?

Labeling and FAERS entries often list Mylan Pharmaceuticals Inc. in connection with 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.