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Sapropterin Side Effects

The most commonly reported side effects of sapropterin include therapy non-responder, headache, and maternal exposure during pregnancy, based on 5,846 FDA adverse event reports from 2008 to 2025. 6.0% of reports found the drug to be ineffective.

#1 Reported: Therapy Non-responderAll side effects ↓Top Co-Medication: Pegvaliase-pqpzDrug interactions ↓56% of Reports Are AdultDemographics ↓

Sapropterin side effects

Percentages show how often each reaction appears relative to total reports for sapropterin.

1
Drug Ineffective6.0%350
2
Therapy Non-responder5.8%339
3
Headache5.2%306
4
Maternal Exposure During Pregnancy4.6%267
5
Vomiting4.3%253
6
Diarrhoea4.1%239
7
Amino Acid Level Increased3.3%192
8
Nausea3.2%187
9
Anxiety3.0%173
10
Abdominal Pain Upper2.9%170
11
Abdominal Discomfort2.5%148
12
Arthralgia2.4%138
13
Cough2.3%132
14
Nasopharyngitis2.1%120
15
Malaise2.0%119

These are voluntary reports and do not establish that sapropterin caused these reactions.

Report severity

17.9%Serious1,044 reports
7.2%Hospitalizations418 reports
1.3%Fatal75 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sapropterin drug interactions

Other drugs that appear in adverse event reports alongside sapropterin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Pegvaliase-pqpz8.3%488
2
Levodopa0.3%17
3
Carbidopa0.3%15
4
Ciprofloxacin<0.1%4
5
Cannabidiol<0.1%4
6
Selegiline<0.1%4
7
Quetiapine-fumarate<0.1%3
8
Methylphenidate<0.1%3
9
Pramipexole-dihydrochloride<0.1%3
10
Sertraline-hydrochloride<0.1%3
11
Cetirizine-hydrochloride<0.1%3
12
Loratadine<0.1%3
13
Ivacaftor<0.1%3
14
Tobramycin<0.1%3
15
Amphetamine<0.1%2

Taken alongside

1
Cetirizine-hydrochloride5.4%315
2
Ergocalciferol3.7%217
3
Famotidine3.6%209
4
Epinephrine2.9%172
5
Omeprazole2.2%130
6
Albuterol2.2%128
7
Fluticasone2.2%126
8
Ibuprofen2.0%116
9
Acetaminophen1.9%111
10
Loratadine1.7%101
11
Sertraline-hydrochloride1.6%94
12
Levodopa1.2%73
13
Montelukast-sodium1.2%73
14
Buspirone-hydrochloride1.2%73
15
Levothyroxine-sodium1.2%69

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports sapropterin side effects

49.4% of sapropterin adverse event reports involve female patients and 32.0% involve male patients. The largest age group is adult at 56%. These figures reflect who reports side effects, not underlying risk.

Sex

Female49.4%
Male32.0%
Unknown18.5%

Age group

< 25.5%
2–1124.5%
12–1713.1%
18–6456.2%
65+0.8%

What is sapropterin used for

Conditions and purposes for which patients were taking sapropterin when the adverse event was reported.

Amino Acid Level AbnormalAmino Acid Level DecreasedAmino Acid Level IncreasedAmino Acid Metabolism DisorderAnorectal DisorderAttention Deficit/hyperactivity DisorderAutonomic Nervous System ImbalanceAgranulocytosisAmino Acid Level AbnormalAmino Acid Level DecreasedAmino Acid Level IncreasedAntiviral TreatmentAttention Deficit Hyperactivity DisorderAutism Spectrum DisorderCardiac Failure

Showing 15 of 67 indications

Sapropterin brand names and reporting trend

Sapropterin is sold under the brand name Sapropterin Dihydrochloride.

Brand names

Sapropterin Dihydrochloride566

Quarterly reports (2008–2025)

20082010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking sapropterin with another medication?

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