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Generic Name: sapropterin (SAP roe TER in)
Brand Names: Kuvan
Kuvan is used to help the body activate the enzyme needed to control blood levels of phenylalanine. Learn about side effects, interactions and indications.
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Drug Information:
Kuvan (sapropterin) is a synthetic form of a natural substance that activates an enzyme needed to break down phenylalanine in the body. Phenylketonuria (PKU) is a disorder in which the body cannot break down phenylalanine. Elevated phenylalanine levels can cause problems with thinking and behavior. Kuvan is used to lower blood levels of phenylalanine in people with a certain type of PKU. Before using Kuvan, tell your doctor if you are allergic to any drugs, or if you have liver disease, a history of stomach ulcer or bleeding, or a seizure disorder. Learn more

Kuvan Side Effects

Kuvan Side Effects

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.

In Summary

Common side effects of Kuvan include: headache and rhinorrhea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to sapropterin: oral powder for solution, 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

  • Fever

Incidence not known

  • Burning feeling in the chest or stomach
  • cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fidgeting or moving around too much
  • indigestion
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash, hives, or itching
  • stomach upset
  • talking too much
  • tenderness in the stomach area
  • tightness in the chest
  • unusual tiredness or weakness

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

  • Diarrhea
  • headache
  • runny nose
  • sore throat
  • vomiting

Less common

  • Stuffy nose

For Healthcare Professionals

Applies to sapropterin: oral powder for reconstitution, oral tablet soluble


The more commonly reported adverse effects include headache, rhinorrhea, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion.

Nervous system

Two cases of hyperactivity have been received during the postmarketing period; in 1 case, the patient had inadvertently received an overdose of this drug.

Very common (10% or more): Headache (15%)

Common (1% to 10%): Dizziness

Frequency not reported: Convulsions, exacerbation of convulsions, overstimulation

Postmarketing reports: Hyperactivity


Very common (10% or more): Rhinorrhea (11%), pharyngolaryngeal pain (10%)

Common (1% to 10%): Cough, nasal congestion, pharyngitis, upper respiratory tract infection

Frequency not reported: Respiratory failure

Postmarketing reports: Pharyngitis


Very common (10% or more): Low phenylalanine levels, non-response to therapy

Common (1% to 10%): Hypophenylalaninemia

Not all patients respond to therapy; in clinical trials, 25% to 44% of pediatric phenylketonuria (PKU) patients receiving 20 mg/kg/day did not respond to therapy and 80% of adult and pediatric PKU patients receiving 10 mg/kg/day did not respond to therapy.


Common (1% to 10%): Diarrhea, vomiting, nausea, abdominal pain, upper abdominal pain

Frequency not reported: Gastrointestinal bleeding

Postmarketing reports: Oropharyngeal pain, esophageal pain, gastritis, dyspepsia, abdominal pain, nausea, vomiting


Frequency not reported: Myocardial infarction


Common (1% to 10%): Peripheral edema

Frequency not reported: Contusion, postprocedural bleeding, pyrexia


Common (1% to 10%): Agitation

Frequency not reported: Irritability


Common (1% to 10%): Arthralgia


Common (1% to 10%): Polyuria


Postmarketing reports: Hypersensitivity reactions (including serious allergic reactions, anaphylaxis, rash)


Frequency not reported: Rash


Frequency not reported: Increased GGT

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Kuvan