In a clinical trial of 207 patients treated with Nitisinone for HT-1, the most frequent adverse effects, regardless of causality assessment, occurred in the following organ systems:

Liver and Biliary System: hepatic neoplasm 8%, liver failure 7%.

Visual System: conjunctivitis 2%, corneal opacity 2%, keratitis 2%, photophobia 2%, blepharitis 1%, eye pain 1%, cataracts 1%.

Hemic and Lymphatic: thrombocytopenia 3%, leucopenia 3%, porphyria 1%, epistaxis 1%.

Skin and Appendages: pruritis 1%, exfoliative dermatitis 1%, dry skin 1%, maculopapular rash 1%, alopecia 1%.

Adverse reactions that occurred in less than 1% of the patients, regardless of causality assessment, are:

Body as a Whole: death.

Nervous System: seizures, brain tumor, encephalopathy, headache, hyperkinesia.

Cardiovascular: cyanosis.

Digestive System: abdominal pain, diarrhea, enanthema, gastritis, gastroenteritis, gastrointestinal hemorrhage, melena, tooth discoloration.

Liver and Biliary System: elevated hepatic enzymes, hepatic function disorder, liver enlargement.

Metabolic and Nutritional Disorders: dehydration, hypoglycemia, thirst.

Resistance Mechanism Disorder: infection, septicemia, otitis.

Respiratory: bronchitis, respiratory insufficiency.

Musculoskeletal System: pathologic fracture.

Female Reproductive: amenorrhea.

Psychiatric: nervousness, somnolence.

No drug-drug interaction studies have been conducted with Nitisinone.

Drug/Laboratory Test Interactions

None known.

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