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 dispersible

If sapropterin (the active ingredient contained in Kuvan) is not controlling your condition properly, you may have symptoms such as behavior changes, numbness or tingling, or problems with speech, vision, or balance. Call your doctor right away if you have any of these symptoms.

Get emergency medical help if you have any of these signs of an allergic reaction while taking sapropterin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of the serious side effects below:

• seizure (convulsions);

• chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling;

• easy bruising or bleeding;

• fever, chills, body aches, flu symptoms;

• swelling in your hands or feet;

• pain or burning when you urinate;

• weakness or fainting;

• black, bloody, or tarry stools; or

• coughing up blood or vomit that looks like coffee grounds.

Less serious side effects of sapropterin may include:

• nausea, vomiting, stomach pain, diarrhea;

• runny or stuffy nose, cough;

• headache, feeling agitated;

• dizziness; or

• joint pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to sapropterin: oral tablet dispersible

Nervous system

Nervous system side effects including headache (15%), convulsions, exacerbation of convulsions, irritability, overstimulation, agitation, and dizziness have been reported.

Respiratory

Respiratory side effects including upper respiratory tract infection (12%), rhinorrhea (11%), cough (7%), nasal congestion (4%), and respiratory failure have been reported.

Other

Other side effects including pharyngolaryngeal pain (10%), contusion (5%), abdominal pain (5%), and postprocedural bleeding have been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (8%), vomiting (8%), and gastrointestinal bleeding have been reported.

General

General side effects including pyrexia (7%) have been reported.

Dermatologic

Dermatologic side effects including rash (5%) have been reported.

Cardiovascular

Cardiovascular side effects including myocardial infarction and peripheral edema have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia have been reported.

Renal

Renal side effects including polyuria have been reported.

Hepatic

Hepatic side effects including two cases of increased gamma-glutamyltransferase have been reported in non-PKU patients.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.