Kuvan Side Effects

Generic Name: sapropterin

Note: This page contains information about the side effects of sapropterin. Some of the dosage forms included on this document may not apply to the brand name Kuvan.

Not all side effects for Kuvan may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to sapropterin: oral powder for solution, oral tablet disintegrating

In addition to its needed effects, some unwanted effects may be caused by sapropterin (the active ingredient contained in Kuvan). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with sapropterin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Diarrhea
  • headache
  • runny nose
  • sore throat
  • vomiting
Less common
  • Stuffy nose

For Healthcare Professionals

Applies to sapropterin: oral tablet dispersible

General

In phenylketonuria (PKU) trials, the most common side effects were headache, rhinorrhea, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion.

In clinical trials for non-PKU indications, a different formulation was used in patients with disorders other than PKU; some had underlying neurologic disorders or cardiovascular disease. Common side effects were headache, peripheral edema, arthralgia, polyuria, agitation, dizziness, nausea, pharyngitis, abdominal pain, upper abdominal pain, and upper respiratory tract infection. Serious and severe side effects included convulsions, exacerbation of convulsions, dizziness, gastrointestinal bleeding, postprocedural bleeding, headache, irritability, myocardial infarction, overstimulation, and respiratory failure.[Ref]

Nervous system

Very common (10% or more): Headache (15%)
Common (1% to 10%): Dizziness
Frequency not reported: Convulsions, exacerbation of convulsions, overstimulation
Postmarketing reports: Hyperactivity[Ref]

Respiratory

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[Ref]

Metabolic

Very common (10% or more): Low phenylalanine levels
Common (1% to 10%): Hypophenylalaninemia[Ref]

Gastrointestinal

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[Ref]

Cardiovascular

Frequency not reported: Myocardial infarction[Ref]

Other

Common (1% to 10%): Peripheral edema
Frequency not reported: Contusion, postprocedural bleeding, pyrexia[Ref]

Psychiatric

Common (1% to 10%): Agitation
Frequency not reported: Irritability

Musculoskeletal

Common (1% to 10%): Arthralgia[Ref]

Genitourinary

Common (1% to 10%): Polyuria[Ref]

Hypersensitivity

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

Dermatologic

Frequency not reported: Rash[Ref]

Hepatic

Frequency not reported: Increased GGT[Ref]

References

1. "Product Information. Kuvan (sapropterin)." BioMarin Pharmaceutical Inc, Novato, CA.

2. Dubois EA, Cohen AF "Sapropterin." Br J Clin Pharmacol 69 (2010): 576-7

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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