Mitapivat Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 1, 2024.

Applies to mitapivat: oral tablet.

Serious side effects of mitapivat

Along with its needed effects, mitapivat 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 mitapivat:

More common side effects

• blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat

Incidence not known

• back pain
• chills
• clay-colored stools
• confusion
• dark urine
• decreased urination
• fever
• itching, rash
• loss of appetite
• nausea
• pale skin
• stomach pain
• trouble breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Other side effects of mitapivat

Some side effects of mitapivat 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 side effects

• breast discomfort
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• constipation
• dry mouth
• difficulty in moving
• feeling of warmth
• muscle pain or stiffness
• pain in the joints
• pain in the lower back, bottom, hips, or upper legs
• redness of the face, neck, arms and occasionally, upper chest
• sore throat

For healthcare professionals

Applies to mitapivat: oral tablet.

Endocrine adverse events

• Very common (10% or more): Estrone decreased in males (56.3%), estradiol decreased in males (12.5%)
• Common (1% to 10%): Blood testosterone increased in males^[Ref]

In 1 study, increases in serum testosterone and decreases in serum estrone and estradiol were observed in men receiving this drug; these hormone changes persisted throughout the study. Reproductive hormone analyses showed decreases in estrone and estradiol to below the lower limit of the reference range and increases in testosterone to above the upper limit of the reference range where baseline was within normal limits. In patients who discontinued this drug and had follow-up hormone measurements, the hormone changes returned close to the baseline levels 28 days after stopping this drug. In female patients, sex hormone analysis was limited due to physiologic variations in hormones during the menstrual cycle and the use of hormonal contraceptives.^[Ref]

Musculoskeletal

• Very common (10% or more): Back pain (included back pain, sciatica, flank pain; 15%), arthralgia (included arthralgia, joint swelling; 10%)
• Frequency not reported: Rib fracture, musculoskeletal pain^[Ref]

Metabolic

• Very common (10% or more): Increased urate (15%)
• Common (1% to 10%): Hypertriglyceridemia (included hypertriglyceridemia, blood triglycerides increased)^[Ref]

Gastrointestinal

• Common (1% to 10%): Gastroenteritis, constipation, dry mouth (included dry mouth, dry lip)^[Ref]

Cardiovascular

• Common (1% to 10%): Hot flush (included hot flush, flushing), hypertension, arrhythmia (included arrhythmia, tachycardia, heart rate increased, atrial fibrillation)
• Frequency not reported: Atrial fibrillation^[Ref]

Respiratory

• Common (1% to 10%): Oropharyngeal pain^[Ref]

Other

• Common (1% to 10%): Breast discomfort^[Ref]

Nervous system

• Common (1% to 10%): Paresthesia^[Ref]

Hematologic

• Frequency not reported: Acute hemolysis, anemia^[Ref]

Acute hemolysis with subsequent anemia was observed after abrupt interruption or discontinuation of this drug in dose-ranging study.^[Ref]

Further information

Mitapivat side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer