What the label lists and what reports show
Duvelisib side effects
Duvelisib's FDA label: “The most common adverse reactions ( > 20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.” FAERS holds 765 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 diarrhoea (107 reports).
- No generic listed
- Boxed warning
Check it at the source: the duvelisib FDA label on DailyMed (effective December 18, 2025, Secura Bio, Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of COPIKTRA?COPIKTRA may cause serious side effects, including: See "WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT COPIKTRA?" Elevated liver enzymes. COPIKTRA may cause abnormalities in liver blood tests. Your healthcare provider should do blood tests during your treatment with COPIKTRA to check for liver problems. Tell your healthcare provider right away if you get any symptoms of liver problems, including yellowing of your skin or the white part of your eyes (jaundice), pain in the stomach (abdominal) region, bruising or bleeding more easily than normal. Low white blood cell count (neutropenia). Neutropenia is common with COPIKTRA treatment and can sometimes be serious. Your healthcare provider should check your blood counts regularly during treatment with COPIKTRA. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment with COPIKTRA. […]
Source: FDA drug label, Secura Bio, Inc, effective December 18, 2025 (SPL set e3c5ac56-e1f6-473a-bc73-687836534780), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions ( > 20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.
Table 6. Common Nonhematologic Adverse Reactions (≥ 10% Incidence) in Patients with CLL/SLL Receiving COPIKTRA (DUO)
| Reaction | Any Grade (%) 57 23 17 16 15 29 25 | Grade ≥ 3 (%) 25 0 <1 3 0 3 4 | Any Grade (%) 14 11 8 7 7 10 23 | Grade ≥ 3 (%) 2 0 0 0 0 <1 4 |
|---|---|---|---|---|
| Transaminase elevation † d | 11 | 6 | 4 | <1 |
| Weight decreased | 11 | 0 | 2 | 0 |
| Musculoskeletal pain | 17 | 1 | 12 | <1 |
| Cough | 23 | 1 | 16 | 0 |
| Dyspnea | 12 | 3 | 7 | 0 |
| Rash † c | 27 | 11 | 15 | <1 |
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 adverse reactions have been associated with COPIKTRA in clinical trials and are discussed in greater detail in other sections of the prescribing information: Treatment-related Mortality [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Diarrhea or Colitis [see Warnings and Precautions ( 5.3 )] Cutaneous Reactions [see Warnings and Precautions ( 5.4 )] Pneumonitis [see Warnings and Precautions ( 5.5 )] Hepatotoxicity [see Warnings and Precautions ( 5.6 )] Neutropenia [see Warnings and Precautions ( 5.7 )] The most common adverse reactions ( > 20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Secura Bio, Inc. (Secura Bio) at 1-844-973-2872, or U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely variable conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates in clinical trials of another drug and may not reflect the rates observed in practice.
Source: FDA drug label, Secura Bio, Inc, effective December 18, 2025 (SPL set e3c5ac56-e1f6-473a-bc73-687836534780), via openFDA; the full label on DailyMed
What do FAERS reports show?
765 reports list duvelisib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 173 are coded as a death and 252 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 17 reactions below, 14 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?
- Duvelisib: 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