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More information: STITCH, PubChem (stereo-specific compound: 1) and possibly Wikipedia

ATC Code: A16AX07

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3 4 5
Headache Headache 14.9% 13.6% x x x x x
Nervous system disorder Nervous system disorder 14.9% 13.6% x x x x x
Infection Infection 12.2% 23.7% x x
Upper respiratory tract infection Upper respiratory tract infection 12.2% 23.7% x x x x
Infestation Infestation NOS 12.2% 23.7% x x
Nasopharyngitis Rhinorrhoea 10.8% 0% x x x x x
Rhinorrhoea Rhinorrhoea 10.8% 0% x x x x x
Laryngeal pain Pharyngolaryngeal pain 9.46% 1.69% x x x x x
Diarrhoea Diarrhoea 8.11% 5.08% x x x x x
Gastrointestinal disorder Gastrointestinal disorder 8.11% 5.08% x x x
Vomiting Vomiting postmarketing, 8.11% 6.78% x x x x x
Cough Cough 6.76% 5.08% x x x x x
Body temperature increased Body temperature increased 6.76% 6.78% x x x
Contusion Contusion 5.41% 1.69% x x x
Skin disorder Unspecified disorder of skin and subcutaneous tissue 5.41% 6.78% x x
Nasal congestion Nasal congestion 4.05% 0% x x x x x
Abdominal pain Abdominal pain postmarketing, 5.41% 8.47% x x x x x
Gastrointestinal pain Abdominal pain postmarketing, 5.41% 8.47% x x x x x
Anaphylactic shock Anaphylactic shock postmarketing x
Dyspepsia Dyspepsia postmarketing x
Dermatitis Rash postmarketing, 5.41% 6.78% x x x x x
Rash Rash postmarketing, 5.41% 6.78% x x x x x
Gastritis Gastritis postmarketing x x
Hypersensitivity Hypersensitivity postmarketing x x x x
Nausea Nausea postmarketing x x
Pharyngitis Pharyngitis postmarketing x
Convulsion Convulsion postmarketing x x x x
Oesophageal pain Oesophageal pain postmarketing x
Agitation Hyperkinesia postmarketing x
Agitation x x
Hyperkinesia Hyperkinesia postmarketing x
Tetrahydrobiopterin deficiency Tetrahydrobiopterin deficiency postmarketing x x
Oropharyngeal pain Oropharyngeal pain postmarketing x
Arthralgia Arthralgia x x
Musculoskeletal discomfort Arthralgia x x
Cardiovascular disorder Cardiovascular disorder x x
Dizziness Dizziness x x
Gastrointestinal haemorrhage Gastrointestinal haemorrhage x x
Irritability Irritability x x
Mediastinal disorder Mediastinal disorder x
Myocardial infarction Myocardial infarction x x
Acute coronary syndrome Myocardial infarction x x
Neutropenia Neutropenia x
Polyuria Polyuria x x
Urine output increased Polyuria x x
Spinal cord injury Spinal cord injury x
Streptococcal infection Streptococcal infection x
Urinary tract infection Urinary tract infection x
Oedema peripheral Oedema peripheral x x
Malnutrition Malnutrition x
Abdominal pain upper Abdominal pain upper x
Testis cancer Carcinoma testes x
Post procedural haemorrhage Post procedural haemorrhage x x
Respiratory failure Respiratory failure x x


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

Sapropterin dihydrochloride / KUVAN

Side effects:20


Side effects:32


Side effects:33
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