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

ATC Code: A16AX07

Side effects

Options: Show MedDRA Preferred Terms

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