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Givinostat Side Effects

The most commonly reported side effects of givinostat include platelet count decreased, diarrhoea, and blood triglycerides increased, based on 404 FDA adverse event reports from 2021 to 2025.

Givinostat side effects

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

1
Platelet Count Decreased24.0%97
2
Diarrhoea14.6%59
3
Blood Triglycerides Increased11.1%45
4
Nausea7.7%31
5
Vomiting7.4%30
6
Abdominal Discomfort6.9%28
7
Thrombocytopenia6.9%28
8
Product Dose Omission Issue5.7%23
9
Abdominal Pain Upper5.0%20
10
Weight Increased5.0%20
11
Off Label Use4.5%18
12
Pyrexia4.0%16
13
Gastrointestinal Disorder3.7%15
14
Myalgia3.2%13
15
Contusion3.2%13

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

Report severity

22.3%Serious90 reports
8.4%Hospitalizations34 reports
1.7%Fatal7 reports

Seriousness is determined by the reporter, not by OpenClaim.

Givinostat drug interactions

Other drugs that appear in adverse event reports alongside givinostat. 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
Vamorolone28.2%114
2
Zoledronic-acid0.7%3
3
Testosterone0.2%1
4
Prednisone0.2%1
5
Lisinopril0.2%1
6
Deflazacort0.2%1
7
Estropipate0.2%1
8
Amoxicillin0.2%1
9
Valproic-acid0.2%1
10
Levetiracetam0.2%1

Taken alongside

1
Ergocalciferol36.1%146
2
Lisinopril26.7%108
3
Deflazacort14.1%57
4
Eplerenone11.9%48
5
Spironolactone8.9%36
6
Famotidine7.2%29
7
Calcium6.9%28
8
Carvedilol6.7%27
9
Enalapril-maleate6.7%27
10
Albuterol5.9%24
11
Omeprazole5.9%24
12
Metoprolol5.9%24
13
Polyethylene-glycol-33505.4%22
14
Prednisone5.4%22
15
Hydrocortisone5.2%21

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 givinostat side effects

0.5% of givinostat adverse event reports involve female patients and 97.5% involve male patients. The largest age group is adolescent at 40%. These figures reflect who reports side effects, not underlying risk.

Sex

Female0.5%
Male97.5%
Unknown2.0%

Age group

< 20.0%
2–1136.3%
12–1740.1%
18–6423.6%
65+0.0%

What is givinostat used for

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

Duchenne Muscular DystrophyMuscular DystrophyProduct Used For Unknown Indication

Givinostat brand names and reporting trend

Givinostat is sold under the brand name Duvyzat.

Brand names

Duvyzat23

Quarterly reports (20212025)

20212025

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

Taking givinostat with another medication?

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