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ATC Code: A16AX04

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2
Agranulocytosis Agranulocytosis common x x
Conjunctivitis Conjunctivitis common x x
Corneal opacity Corneal opacity common x x
Keratitis Keratitis common x x
Leukopenia Leukopenia common x x
Thrombocytopenia Thrombocytopenia common x
Photophobia Photophobia common x x
Eye pain Eye pain common x x
Blepharitis Blepharitis uncommon x x
Dermatitis exfoliative Dermatitis exfoliative uncommon x x
Leukocytosis Leukocytosis uncommon x
Pruritus Pruritus uncommon x x
Rash erythematous Rash erythematous uncommon x
Abdominal pain Abdominal pain x
Gastrointestinal pain Abdominal pain x
Alopecia Alopecia x
Amenorrhoea Amenorrhoea x
Brain neoplasm Brain neoplasm x
Bronchitis Bronchitis x
Neoplasm malignant Neoplasm malignant x
Infection Infection x
Cyanosis Cyanosis x
Dehydration Dehydration x
Diarrhoea Diarrhoea x
Enanthema Enanthema x
Epistaxis Epistaxis x
Eye disorder Eye disorder x
Gastritis Gastritis x
Gastroenteritis Gastroenteritis x
Gastrointestinal haemorrhage Gastrointestinal haemorrhage x
Headache Headache x
Haemorrhage Haemorrhage x
Haemoglobin Haemorrhage x
Hepatomegaly Hepatomegaly x
Hypoglycaemia Hypoglycaemia x
Hepatic neoplasm Hepatic neoplasm x
Liver nodule x
Melaena Melaena x
Nervousness Nervousness x
Tension Nervousness x
Ear infection Otitis x
Porphyrin metabolism disorder Porphyrin metabolism disorder x
Respiratory failure Respiratory insufficiency x
Convulsion Convulsion x
Sepsis Septicemia x
Thirst Thirst x
Tooth discolouration Tooth discolouration x
Encephalopathy Encephalopathy x
Hepatic failure Hepatic failure x
Cataract Cataract x
Hepatic function abnormal Hepatic function abnormal x
Dry skin Dry skin x
Skin disorder Unspecified disorder of skin and subcutaneous tissue x
Rash maculo-papular Rash maculo-papular x
Agitation Hyperkinesia x
Hyperkinesia Hyperkinesia x
Somnolence Somnolence x


Information about indications was extracted from the indications and usage sections of the labels.

nitisinone / nitisinone

Side effects:16


Side effects:48
Source:FDA Structured Product Label

Color scheme:


    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    no frequency information
    not found on label