How common are sapropterin side effects?

What are the reported side effects of sapropterin?

According to the FDA [1], the most common side effects of sapropterin dihydrochloride (Kuvan) reported in clinical trials include:

* Vomiting (up to 22.6%)
* Diarrhea (up to 15.4%)
* Abdominal pain (up to 13.9%)
* Nausea (up to 12.2%)
* Fatigue (up to 10.3%)

What about more serious side effects?

In rare cases, patients taking sapropterin may experience serious side effects such as:

* Increased liver enzymes (up to 3.4%) [1]
* Thrombocytopenia (up to 1.1%) [1]
* Anaphylaxis (less than 1%) [2]

Who is at risk of sapropterin side effects?

The risk of side effects may be increased for certain individuals:

* Children under 4 years old [2]
* Patients with a history of liver disease or kidney disease [3]
* Pregnant or breastfeeding women [3]

What can patients do to minimize side effects?

To minimize the risk of side effects, patients should:

* Follow the recommended dosage and administration instructions [1]
* Monitor their liver enzymes and kidney function regularly [3]
* Report any unusual symptoms or side effects to their healthcare provider [1]

References:

[1] FDA. (2010). Kuvan (Sapropterin Dihydrochloride) Prescribing Information.

[2] Kuvan Package Insert (PDF). Retrieved from DrugPatentWatch.com ${index}

[3] EMA. (2014). Sapropterin Dihydrochloride (Kuvan) Summary of Product Characteristics.

Sources:

1. FDA
2. DrugPatentWatch.com
3. EMA