Dilantin Steri-Vial

Dilantin Steri-Vial Adverse Reactions

phenytoin

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
The following adverse reactions have been reported with phenytoin (frequency unknown - cannot be estimated from available data): Body as a Whole: Anaphylactoid reaction and anaphylaxis.
Cardiovascular System: Asystole/cardiac arrest, bradycardia, and hypotension have been observed (see General and Cardiovascular Effects under Precautions).
Central Nervous System: Adverse reactions in this body system are common and are usually dose related. Reactions include nystagmus, ataxia, slurred speech, decreased coordination, and mental confusion. Cerebellar atrophy has been reported, and appears more likely in settings of elevated phenytoin levels and/or long-term phenytoin use. (see Central Nervous System Effect under Precautions).
Dizziness, vertigo, insomnia, transient nervousness, motor twitching, headache, paresthesia, and somnolence have also been observed.
There have also been rare reports of phenytoin-induced dyskinesia, including chorea, dystonia, tremor, and asterixis, similar to those induced by phenothiazine and other neuroleptic drugs.
A predominantly sensory peripheral polyneuropathy has been observed in patients receiving long-term phenytoin therapy.
Connective Tissue System: Coarsening of the facial features, enlargement of the lips, gingival hyperplasia, hypertrichosis, and Peyronie's disease.
Gastrointestinal System: Acute hepatic failure, toxic hepatitis, liver damage, vomiting, nausea, and constipation (see Hepatic Injury under Precautions).
Hematopoietic System: Hematopoietic complications, some fatal, have occasionally been reported in association with administration of phenytoin. These have included thrombocytopenia, leukopenia, granulocytopenia, agranulocytosis, and pancytopenia with or without bone marrow suppression. Macrocytosis and megaloblastic anemia have also occurred. Lymphadenopathy including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin's disease have been reported (see Hematopoietic System under Precautions).
Immunologic: HSS/DRESS (see Hypersensitivity Syndrome/Drug Reaction with Eosinophilia and Systemic Symptoms under Precautions), systemic lupus erythematosus, periarteritis nodosa, and immunoglobulin abnormalities. Angioedema has been reported (see Angioedema under Precautions).
Injection Site: Local irritation, inflammation, tenderness, necrosis, and sloughing of skin have been reported with or without extravasation of IV phenytoin. Edema, discoloration and pain distal to the site of injection (described as "purple glove syndrome") have also been reported (see Local Toxicity (Including Purple Glove Syndrome) under Precautions).
Investigations: Thyroid function test abnormal.
Dermatologic System: Dermatological manifestations, sometimes accompanied by fever, have included scarlatiniform or morbilliform rashes. A morbilliform rash (measles-like) is the most common; other types of dermatitis are seen more rarely. Other more serious forms that may be fatal have included bullous, exfoliative or purpuric dermatitis, lupus erythematosus, AGEP, SJS, and TEN (see Serious Dermatologic Reactions under Precautions). Urticaria has been reported.
Special Senses: Taste perversion.
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