SAPROPTERIN for Phenylketonuria: Side Effects & Safety Data
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There are 4,231 adverse event reports in the FDA FAERS database where SAPROPTERIN was used for Phenylketonuria.
Most Reported Side Effects for SAPROPTERIN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 356 | 6.4% | 1 | 7 |
| Therapy non-responder | 348 | 6.3% | 0 | 1 |
| Headache | 309 | 5.6% | 0 | 5 |
| Maternal exposure during pregnancy | 277 | 5.0% | 0 | 21 |
| Vomiting | 260 | 4.7% | 0 | 28 |
| Diarrhoea | 238 | 4.3% | 0 | 15 |
| Amino acid level increased | 194 | 3.5% | 0 | 7 |
| Nausea | 189 | 3.4% | 0 | 13 |
| Abdominal pain upper | 179 | 3.2% | 0 | 4 |
| Anxiety | 174 | 3.1% | 0 | 7 |
| Abdominal discomfort | 153 | 2.8% | 0 | 3 |
| Arthralgia | 142 | 2.6% | 0 | 4 |
| Cough | 138 | 2.5% | 0 | 9 |
| Nasopharyngitis | 131 | 2.4% | 0 | 4 |
| Malaise | 119 | 2.2% | 0 | 1 |
Other Indications for SAPROPTERIN
Product used for unknown indication (1,100)
Hyperphenylalaninaemia (117)
Tetrahydrobiopterin deficiency (60)
Foetal exposure during pregnancy (27)
Dopa-responsive dystonia (7)
Metabolic disorder (7)
Immunodeficiency (6)