ADVERSE REACTIONS
Central Nervous System: The most common manifestations encountered with phenytoin therapy are referable to this system and are usually dose related. These include nystagmus, ataxia, slurred speech, decreased coordination, and mental confusion. Dizziness, insomnia, transient nervousness, motor twitchings, and headaches have also been observed. There have also been rare reports of phenytoin induced dyskinesias, 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.
Gastrointestinal System: Nausea, vomiting, constipation, toxic hepatitis and liver damage.
Integumentary 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 which may be fatal have included bullous, exfoliative or purpuric dermatitis, lupus erythematosus, Stevens-Johnson Syndrome, and toxic epidermal necrolysis (see PRECAUTIONS).
Hemopoietic System: Hemopoietic 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. While macrocytosis and megaloblastic anemia have occurred, these conditions usually respond to folic acid therapy. Lymphadenopathy including benign lymph node hyperplasia, pseudolymphoma, lymphoma, and Hodgkin's Disease have been reported (see WARNINGS).
Connective Tissue System: Coarsening of the facial features, enlargement of the lips, gingival hyperplasia, hypertrichosis, and Peyronie's Disease.
Immunologic: Hypersensitivity syndrome (which may include, but is not limited to, symptoms such as arthralgias, eosinophilia, fever, liver dysfunction, lymphadenopathy or rash), systemic lupus erythematosus, periarteritis nodosa and immunoglobulin abnormalities.
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REPORTS OF SUSPECTED PHENYTOIN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Phenytoin. The information is not vetted and should not be considered as verified clinical evidence.
Possible Phenytoin side effects / adverse reactions in 51 year old female
Reported by a health professional (non-physician/pharmacist) from Singapore on 2011-10-05
Patient: 51 year old female
Reactions: Rash, Dermatitis Exfoliative
Suspect drug(s):
Phenytoin
Dosage: unk
Start date: 2011-08-04
End date: 2011-08-20
Ciprofloxacin HCL
Dosage: unk
Start date: 2011-08-16
End date: 2011-08-18
Gentamicin
Dosage: unk
Start date: 2011-08-18
End date: 2011-08-20
Possible Phenytoin side effects / adverse reactions in 31 year old male
Reported by a pharmacist from United States on 2011-10-06
Patient: 31 year old male weighing 75.2 kg (165.4 pounds)
Reactions: Weight Decreased, Gingival Hypertrophy, Toxicity TO Various Agents
Adverse event resulted in: hospitalization
Suspect drug(s):
Phenytoin
Possible Phenytoin side effects / adverse reactions in 51 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-06
Patient: 51 year old female
Reactions: Drug Eruption, Hypersensitivity, Metastases TO Meninges, Inappropriate Antidiuretic Hormone Secretion
Adverse event resulted in: death
Suspect drug(s):
Phenytoin
Indication: Ovarian Cancer Metastatic
Paclitaxel
Dosage: 3 courses at 3 week interval. 160 mg/m2) weekly for a total of 20 courses,
Indication: Ovarian Cancer Metastatic
Cisplatin
Indication: Ovarian Cancer Metastatic
Carboplatin
Dosage: auc - 5
Indication: Ovarian Cancer Metastatic
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