What the label lists and what reports show
Givinostat side effects
Givinostat's FDA label: “Most common adverse reactions (≥10% in DUVYZAT-treated patients) are diarrhea, abdominal pain, thrombocytopenia, nausea/vomiting, hypertriglyceridemia, and pyrexia.” FAERS holds 560 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is platelet count decreased (118 reports).
- No generic listed
Check it at the source: the givinostat FDA label on DailyMed (effective November 21, 2024); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of DUVYZAT?DUVYZAT can cause serious side effects, including: see “ What is the most important information I should know about DUVYZAT? ” changes in the electrical activity of your heart called QT Prolongation. QT Prolongation can increase the risk of developing a type of irregular heart rhythm known as Torsades de Pointes. Call your healthcare provider right away if you feel faint, have an irregular heartbeat, feel dizzy, or lose consciousness. The most common side effects of DUVYZAT include: loose, watery stools (diarrhea) nausea vomiting stomach (abdominal) pain low platelet counts in the blood increased fat levels in the blood fever Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of DUVYZAT. For more information, ask your healthcare provider or pharmacist. […]
Source: FDA drug label, Italfarmaco SPA, effective November 21, 2024 (SPL set 1a28a3db-7880-4ac2-a2f2-2b4e362aafb6), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥10% in DUVYZAT-treated patients) are diarrhea, abdominal pain, thrombocytopenia, nausea/vomiting, hypertriglyceridemia, and pyrexia.
Table 3. Adverse Reactions Reported in >5% of DUVYZAT-Treated Patients and at Least 5% Greater than Placebo in Study 1
| Adverse Reaction | DUVYZAT N=118 % | Placebo N=61 % |
|---|---|---|
| Diarrhea | 37 | 20 |
| Abdominal pain | 34 | 25 |
| Thrombocytopenia Thrombocytopenia includes platelet count decreased and thrombocytopenia | 33 | 0 |
| Nausea/Vomiting | 32 | 18 |
| Hypertriglyceridemia | 23 | 7 |
| Pyrexia | 13 | 8 |
| Myalgia | 9 | 3 |
| Rash | 9 | 2 |
| Arthralgia | 8 | 2 |
| Fatigue | 8 | 0 |
| Constipation | 7 | 2 |
| Decreased appetite | 7 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described below and elsewhere in the labeling: Hematological Changes [see Warnings and Precautions (5.1) ] Increased Triglycerides [see Warnings and Precautions (5.2) ] Gastrointestinal Disturbances [see Warnings and Precautions (5.3) ] QTc Prolongation [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥10% in DUVYZAT-treated patients) are diarrhea, abdominal pain, thrombocytopenia, nausea/vomiting, hypertriglyceridemia, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ITF Therapeutics, LLC. at 1-833-582-4312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In controlled and uncontrolled trials in patients with confirmed DMD, 222 male patients aged 6 years and older were treated with DUVYZAT, including 210 patients treated for ≥ 6 months, 187 patients for ≥ 12 months, and 105 patients for ≥ 24 months. …
Source: FDA drug label, Italfarmaco SPA, effective November 21, 2024 (SPL set 1a28a3db-7880-4ac2-a2f2-2b4e362aafb6), via openFDA; the full label on DailyMed
What do FAERS reports show?
560 reports list givinostat among the medicines taken, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 57 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Givinostat: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions