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 section).
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 section).
Connective Tissue System: Coarsening of the facial features, enlargement of the lips, gingival hyperplasia, hypertrichosis, and Peyronie's Disease.
Cardiovascular: Periarteritis nodosa. 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, and immunoglobulin abnormalities.
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REPORTS OF SUSPECTED PHENYTEK SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Phenytek. The information is not vetted and should not be considered as verified clinical evidence.
Possible Phenytek side effects / adverse reactions in 47 year old male
Reported by a consumer/non-health professional from United States on 2011-10-11
Patient: 47 year old male weighing 70.3 kg (154.7 pounds)
Reactions: Product Substitution Issue, Cervical Vertebral Fracture, Product Measured Potency Issue, Dizziness, Reaction TO Drug Excipients, Toxicity TO Various Agents, Loss of Consciousness
Adverse event resulted in: life threatening event, hospitalization, disablity
Suspect drug(s):
Phenytek
Other drugs received by patient: Phenytek
Possible Phenytek side effects / adverse reactions in 73 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-11
Patient: 73 year old male weighing 62.6 kg (137.7 pounds)
Reactions: Anticonvulsant Drug Level Increased, Gait Disturbance, Fall
Suspect drug(s):
Prozac
Dosage: 20mg po qd
Administration route: Oral
Indication: Major Depression
Start date: 2010-06-04
Phenytek
Dosage: 200mg po bid
Administration route: Oral
Indication: Convulsion
Possible Phenytek side effects / adverse reactions in 41 year old female
Reported by a pharmacist from United States on 2012-05-31
Patient: 41 year old female
Reactions: Drug Ineffective, Anticonvulsant Drug Level Decreased, Convulsion
Adverse event resulted in: hospitalization
Suspect drug(s):
Phenytek
Administration route: Oral
Indication: Convulsion
Dilantin
Administration route: Oral
Indication: Convulsion
Other drugs received by patient: Calcium
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