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Mitapivat Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 9, 2023.

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

Incidence not known

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

For Healthcare Professionals

Applies to mitapivat: oral tablet.

Endocrine

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]

References

1. Product Information. Pyrukynd (mitapivat). Agios Pharmaceuticals, Inc. 2022.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer