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Mitapivat Side Effects

The most commonly reported side effects of mitapivat include haemoglobin decreased, fatigue, and product dose omission issue, based on 708 FDA adverse event reports from 2022 to 2025. 6.4% of reports found the drug to be ineffective.

Mitapivat side effects

Percentages show how often each reaction appears relative to total reports for mitapivat.

1
Haemoglobin Decreased25.7%182
2
Fatigue12.3%87
3
Product Dose Omission Issue11.3%80
4
Off Label Use8.1%57
5
Arthralgia7.9%56
6
Headache6.5%46
7
Drug Ineffective6.4%45
8
Malaise5.4%38
9
Back Pain5.2%37
10
Dyspnoea4.8%34
11
Covid-194.2%30
12
Asthenia4.2%30
13
Product Dose Omission In Error4.1%29
14
Pain3.7%26
15
Dizziness3.4%24

These are voluntary reports and do not establish that mitapivat caused these reactions.

Report severity

18.1%Serious128 reports
9.7%Hospitalizations69 reports
0.7%Fatal5 reports

Seriousness is determined by the reporter, not by OpenClaim.

Mitapivat drug interactions

Other drugs that appear in adverse event reports alongside mitapivat. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Carglumic-acid0.8%6
2
Deferiprone0.7%5
3
Rifaximin0.3%2
4
Sulfamethoxazole0.3%2
5
Trimethoprim0.3%2
6
Metoclopramide-hydrochloride0.1%1
7
Penicillin0.1%1
8
Mycophenolate0.1%1
9
Prednisone0.1%1
10
Darbepoetin-alfa0.1%1
11
Teduglutide0.1%1
12
Ferrous-fumarate0.1%1
13
Folic-acid0.1%1
14
Hydromorphone-hydrochloride0.1%1

Taken alongside

1
Folic-acid4.9%35
2
Ergocalciferol2.7%19
3
Deferasirox2.5%18
4
Omeprazole2.0%14
5
Aspirin1.7%12
6
Metoprolol1.4%10
7
Acetaminophen1.1%8
8
Deferoxamine-mesylate1.0%7
9
Tacrolimus1.0%7
10
Apixaban1.0%7
11
Pantoprazole-sodium1.0%7
12
Amlodipine1.0%7
13
Ursodiol0.8%6
14
Famotidine0.8%6
15
Montelukast-sodium0.8%6

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports mitapivat side effects

54.0% of mitapivat adverse event reports involve female patients and 39.3% involve male patients. The largest age group is adult at 85%. These figures reflect who reports side effects, not underlying risk.

Sex

Female54.0%
Male39.3%
Unknown6.8%

Age group

< 20.5%
2–110.5%
12–171.6%
18–6485.3%
65+12.0%

What is mitapivat used for

Conditions and purposes for which patients were taking mitapivat when the adverse event was reported.

Acquired AspleniaAnaemiaAnaemia Of Chronic DiseaseAspleniaAutoimmune Haemolytic AnaemiaChronic Kidney DiseaseHaemolytic AnaemiaHaemolytic Anaemia Enzyme SpecificHereditary HaemochromatosisHereditary Haemolytic AnaemiaMelanocytic NaevusOff Label UseProduct Used For Unknown IndicationProteinuriaPyruvate Kinase Deficiency Anaemia

Showing 15 of 22 indications

Mitapivat brand names and reporting trend

Mitapivat is sold under the brand name Aqvesme.

Brand names

Aqvesme767

Quarterly reports (20222025)

202220242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking mitapivat with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.