What are the most common side effects of PHENYTOIN SODIUM?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for PHENYTOIN SODIUM. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is PHENYTOIN SODIUM the same as Phenytoin Sodium?

Phenytoin Sodium is a brand name for PHENYTOIN SODIUM. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

PHENYTOIN SODIUM

Q: What is PHENYTOIN SODIUM used for?

PHENYTOIN SODIUM (brand name Phenytoin Sodium) is a Anticonvulsant indicated for 1 INDICATIONS AND USAGE Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous phenytoin can also be substituted, as short-term use.

Q: How does PHENYTOIN SODIUM work?

PHENYTOIN SODIUM works through the following mechanism: 12.1 Mechanism of Action The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges..

Anticonvulsant

Brand names: Phenytoin Sodium

Intramuscular, Intravenous

Mechanism of Action

12.1 Mechanism of Action The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges.

Indications

1 INDICATIONS AND USAGE Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic-clonic status epilepticus

and prevention and treatment of seizures occurring during neurosurgery. Intravenous phenytoin can also be substituted

as short-term use

for oral phenytoin. Parenteral phenytoin should be used only when oral phenytoin administration is not possible [see Dosage and Administration (2.1

as short-term use

for oral phenytoin. Parenteral phenytoin should be used only when oral phenytoin administration is not possible. ( 1 )

Contraindications

• 4 CONTRAINDICATIONS Phenytoin Sodium Injection is contraindicated in patients with: A history of hypersensitivity to phenytoin
• its inactive ingredients
• or other hydantoins [see Warnings and Precautions (5.5) ] . Sinus bradycardia
• sino-atrial block
• second and third degree A-V block

FDA Warnings

5 WARNINGS AND PRECAUTIONS Withdrawal Precipitated Seizure : May precipitate status epilepticus
2 ) Serious Dermatologic Reactions : Discontinue phenytoin at the first sign of a rash, unless the rash is clearly not drug-related
1 Cardiovascular Risk Associated with Rapid Infusion Rapid intravenous administration of Phenytoin Sodium Injection increases the risk of adverse cardiovascular reactions, including severe hypotension and cardiac arrhythmias
Cardiac arrhythmias have included bradycardia, heart block, ventricular tachycardia, and ventricular fibrillation which have resulted in asystole, cardiac arrest, and death

Known Side Effects

8 documented side effects by frequency

Drug Not Working

>10%

Falls

1-10%

Dizziness

1-10%

Headache

0.1-1%

Nausea

0.1-1%

Fatigue

0.1-1%

Fever

0.1-1%

Rash

0.1-1%

Community Discussions

No community discussions found for PHENYTOIN SODIUM yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → PHENYTOIN SODIUM openFDA label JSON → PHENYTOIN SODIUM FAERS adverse-event reports → PHENYTOIN SODIUM ClinicalTrials.gov → completed Phase 2+ trials of PHENYTOIN SODIUM

Compare With

18 available comparisons

Formulations

Dosage Forms

Tablet

Route

Intramuscular, Intravenous