Applies to voxelotor: oral tablet, oral tablet for suspension.

Serious side effects of Voxelotor

Along with its needed effects, voxelotor 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 voxelotor:

Rare

• Black, tarry stools
• chest pain
• chills
• cough
• fever
• hives or welts, itching or skin rash
• painful or difficult urination
• redness of the skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Other side effects of Voxelotor

Some side effects of voxelotor 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
• nausea
• stomach pain

For Healthcare Professionals

Applies to voxelotor: oral tablet, oral tablet soluble.

General

The more commonly reported adverse reactions have included headache, diarrhea, abdominal pain, nausea, fatigue, rash, and pyrexia^[Ref]

Hypersensitivity

Clinical manifestations of serious hypersensitivity reactions may include generalized rash, urticaria, mild shortness of breath, mild facial swelling, and eosinophilia. Drug hypersensitivity has been reported in less than 10% of patients.

Rare (less than 0.1%): Serious hypersensitivity reactions

Frequency not reported: Drug hypersensitivity

Gastrointestinal

Very common (10% or more): Diarrhea (up to 23%), abdominal pain (up to 23%; including abdominal pain, lower abdominal pain, and upper abdominal pain), nausea (up to 19%), vomiting (33%)

Dermatologic

Rash includes terms of rash, urticaria, generalized rash, maculo-papular rash, pruritic rash, papular rash, erythematous rash, and vesicular rash.

Very common (10% or more): Rash (up to 20%)

Other

Very common (10% or more): Fatigue (14%), pyrexia (up to 36%)

Nervous system

Very common (10% or more): Headache (up to 32%)