Phenytek (Phenytoin Sodium Extended Release) - Side Effects and Adverse Reactions

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.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO PHENYTEK

Possible Phenytek side effects / adverse reactions in 50 year old male

Reported by a individual with unspecified qualification from United States on 2007-02-08

Patient: 50 year old male

Reactions: Diplopia, Anticonvulsant Drug Level Above Therapeutic, Injection Site Pain, Fall, Convulsion

Adverse event resulted in: hospitalization

Suspect drug(s):
Rebif
    Dosage: 44 mcg, 3 in 1 weeks, subcutaneous
    Indication: Multiple Sclerosis
    Start date: 2006-08-08

Phenytek
    Dosage: 200 mg, 2 in 1 days, oral
    Administration route: Oral
    Start date: 2006-01-01

Other drugs received by patient: Unspecified Medication FOR High Blood Pressure (Antihypertensives)

Possible Phenytek side effects / adverse reactions in 50 year old male

Reported by a individual with unspecified qualification from United States on 2007-02-28

Patient: 50 year old male

Reactions: Diplopia, Anticonvulsant Drug Level Above Therapeutic, Injection Site Pain, Fall

Adverse event resulted in: hospitalization

Suspect drug(s):
Rebif
    Dosage: 44 ug; 3 times per week; subcutaneous
    Indication: Multiple Sclerosis
    Start date: 2006-08-08

Phenytek
    Dosage: 200 mg; twice a day; oral
    Administration route: Oral
    Indication: Convulsion
    Start date: 2006-01-01

Other drugs received by patient: Antihypertensives

Possible Phenytek side effects / adverse reactions in 37 year old female

Reported by a lawyer from United States on 2007-03-23

Patient: 37 year old female

Reactions: Rash Generalised, Unresponsive TO Stimuli, Hypotension, Cerebral Haemorrhage, Electromechanical Dissociation, Haemodialysis, Grand MAL Convulsion, Nephritis Interstitial, Subarachnoid Haemorrhage, Ventricular Tachycardia, Hypoxia, Ventricular Fibrillation, Stevens-Johnson Syndrome

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Phenytek