Kuvan Side Effects
Generic name: sapropterin
Note: This document contains side effect information about sapropterin. Some of the dosage forms listed on this page may not apply to the brand name Kuvan.
Some side effects of Kuvan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to sapropterin: oral tablet disintegrating
Along with its needed effects, sapropterin (the active ingredient contained in Kuvan) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking sapropterin:More common
Some side effects of sapropterin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- runny nose
- stuffy nose
For Healthcare Professionals
Applies to sapropterin: oral tablet dispersible
Nervous system side effects including headache (15%), convulsions, exacerbation of convulsions, irritability, overstimulation, agitation, and dizziness have been reported.
Respiratory side effects including upper respiratory tract infection (12%), rhinorrhea (11%), cough (7%), nasal congestion (4%), and respiratory failure have been reported.
Other side effects including pharyngolaryngeal pain (10%), contusion (5%), abdominal pain (5%), and postprocedural bleeding have been reported.
Gastrointestinal side effects including diarrhea (8%), vomiting (8%), and gastrointestinal bleeding have been reported.
General side effects including pyrexia (7%) have been reported.
Dermatologic side effects including rash (5%) have been reported.
Cardiovascular side effects including myocardial infarction and peripheral edema have been reported.
Musculoskeletal side effects including arthralgia have been reported.
Renal side effects including polyuria have been reported.
Hepatic side effects including two cases of increased gamma-glutamyltransferase have been reported in non-PKU patients.
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