What the label lists and what reports show
Pirtobrutinib side effects
Pirtobrutinib's FDA label: “Most common adverse reactions (≥ 30%), including laboratory abnormalities, are fatigue, neutrophil count decreased, platelet count decreased, hemoglobin decreased, leukocytes decreased, lymphocyte count decreased and calcium decreased.” FAERS holds 823 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 malignant neoplasm progression (74 reports).
- No generic listed
Check it at the source: the pirtobrutinib FDA label on DailyMed (effective March 6, 2026, Eli Lilly and Company); 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 JAYPIRCA?JAYPIRCA can cause serious side effects, including: Infections can happen during treatment with JAYPIRCA. These infections can be serious and may lead to death. Your healthcare provider may prescribe vaccines and certain medicines if you have an increased risk of getting infections. Tell your healthcare provider right away if you develop fever, chills, weakness, flu-like symptoms, or any other signs of infection during treatment with JAYPIRCA. Bleeding problems (hemorrhage) can happen during treatment with JAYPIRCA and can be serious and may lead to death. Your risk of severe bleeding may increase if you are also taking a blood thinner medicine. […]
Source: FDA drug label, NDA216059 (Loxo Oncol), as published by Eli Lilly and Company, effective March 6, 2026 (SPL set bd551845-0878-49a4-860f-839b83f6b801), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 30%), including laboratory abnormalities, are fatigue, neutrophil count decreased, platelet count decreased, hemoglobin decreased, leukocytes decreased, lymphocyte count decreased and calcium decreased.
Table 4: Adverse Reactions (≥ 10%) in Patients with CLL/SLL Who Received JAYPIRCA
| Adverse Reactions a | All Grades (%) | Grade 3-4 (%) |
|---|---|---|
| Fatigue | 36 | 2.7 |
| Edema | 21 | 0 |
| Pyrexia | 20 | 2.7 |
| Bruising | 36 | 0 |
| Fall | 14 | 0.9 |
| Cough | 33 | 0 |
| Dyspnea | 22 | 2.7 |
| Mucositis | 12 | 0.9 |
| Musculoskeletal pain | 32 | 0.9 |
| Arthritis or arthralgia | 19 | 1.8 |
| Upper respiratory tract infections | 13 | 2.7 |
| Respiratory tract infection | 11 | 1.8 |
| Diarrhea | 26 | 0 |
| Abdominal pain | 25 | 2.7 |
| Nausea | 21 | 0 |
| Constipation | 14 | 0 |
| Hypertension | 12 | 5 |
| Headache | 20 | 0.9 |
| Peripheral neuropathy | 16 | 3.6 |
| Dizziness | 15 | 0 |
| Rash | 19 | 0.9 |
| Insomnia | 14 | 0 |
| Decreased appetite | 12 | 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 elsewhere in the labeling: Infections [see Warnings and Precautions ( 5.1 )] Hemorrhage [see Warnings and Precautions ( 5.2 )] Cytopenias [see Warnings and Precautions ( 5.3 )] Atrial Fibrillation and Atrial Flutter [see Warnings and Precautions ( 5.4 )] Second Primary Malignancies [see Warnings and Precautions ( 5.5 )] Hepatotoxicity, including DILI [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (≥ 30%), including laboratory abnormalities, are fatigue, neutrophil count decreased, platelet count decreased, hemoglobin decreased, leukocytes decreased, lymphocyte count decreased and calcium decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) 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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in the general patient population. The data in the WARNINGS AND PRECAUTIONS reflect exposure to JAYPIRCA as a single-agent, administered at 200 mg once daily in 704 patients with hematologic malignancies in the BRUIN and the BRUIN-CLL-321 studies. …
Source: FDA drug label, NDA216059 (Loxo Oncol), as published by Eli Lilly and Company, effective March 6, 2026 (SPL set bd551845-0878-49a4-860f-839b83f6b801), via openFDA; the full label on DailyMed
What do FAERS reports show?
823 reports list pirtobrutinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 209 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 20 reactions below, 11 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?
- Pirtobrutinib: 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