What the label lists and what reports show
Brigatinib side effects
Brigatinib's FDA label: “The most common adverse reactions (≥25%) with ALUNBRIG were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and dyspnea.” FAERS holds 3,630 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 (253 reports).
- No generic listed
Check it at the source: the brigatinib FDA label on DailyMed (effective January 12, 2026, Takeda Pharmaceuticals America, Inc.); 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 ALUNBRIG?ALUNBRIG may cause serious side effects, including: See " What is the most important information I should know about ALUNBRIG? ". The most common side effects of ALUNBRIG include: diarrhea fatigue nausea rash cough muscle pain headache high blood pressure vomiting difficulty breathing ALUNBRIG may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility. These are not all of the possible side effects of ALUNBRIG. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective January 12, 2026 (SPL set 0fe9ff20-d402-41f3-bc1e-7002ea7007db), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥25%) with ALUNBRIG were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and dyspnea.
Table 3: Adverse Reactions in ≥10% (All Grades Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 ) or ≥2% (Grades 3-4) of Patients by Arm in ALTA 1L (N = 273)
| Reaction | All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3-4 (%) |
|---|---|---|---|---|
| Diarrhea | 53 | 2.2 | 57 | 2.9 |
| Nausea | 30 | 2.2 | 58 | 2.9 |
| Abdominal pain Includes abdominal discomfort, abdominal distension, abdominal pain,… | 24 | 0.7 | 33 | 3.6 |
| Vomiting | 21 | 0.7 | 44 | 2.2 |
| Constipation | 18 | 0 | 42 | 0 |
| Stomatitis Includes aphthous ulcer, mouth ulceration, oral mucosal blistering and… | 13 | 0.7 | 8.8 | 0 |
| Dyspepsia | 8 | 0 | 16 | 0.7 |
| Gastroesophageal reflux disease | 0.7 | 0 | 11 | 0 |
| Rash Includes dermatitis, dermatitis acneiform, dermatitis bullous, dermatitis contact,… | 40 | 2.9 | 17 | 0 |
| Pruritus Included pruritus, allergic pruritus, and generalized pruritus | 20 | 0.7 | 5.8 | 0.7 |
| Cough | 35 | 0 | 20 | 0 |
| Dyspnea Include dyspnea and exertional dyspnea | 25 | 2.9 | 22 Includes Grade 5 events | 3.6 |
| ILD/Pneumonitis | 5.1 | 2.9 | 2.2 | 0.7 |
| Pulmonary embolism | 2.2 | 2.2 | 5.8 | 2.9 |
| Hypertension Includes hypertension and systolic hypertension | 32 | 13 | 8 | 2.9 |
| Fatigue Includes asthenia and fatigue | 32 | 1.5 | 40 | 2.2 |
| Edema Includes angioedema, eye swelling, eyelid edema, face edema, generalized edema, lip… | 18 | 0.7 | 48 | 0.7 |
| Pyrexia | 15 | 0.7 | 15 | 0 |
| Myalgia Includes muscle spasms, muscle twitching, musculoskeletal discomfort,… | 28 | 0 | 23 | 0 |
| Back pain | 21 | 0.7 | 17 | 1.5 |
| Arthralgia | 14 | 0 | 12 | 0 |
| Pain in extremity | 5.1 | 0 | 15 | 0.7 |
| Headache Includes headache and migraine | 22 | 2.2 | 17 | 0 |
| Dizziness | 15 | 0.7 | 20 | 0.7 |
| Peripheral neuropathy Includes burning sensation, dysesthesia, hyperesthesia,… | 11 | 0.7 | 18 | 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 adverse reactions are discussed in greater detail in other sections of the prescribing information: Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.1) ] Hypertension [see Warnings and Precautions (5.2) ] Bradycardia [see Warnings and Precautions (5.3) ] Visual Disturbance [see Warnings and Precautions (5.4) ] Creatine Phosphokinase (CPK) Elevation [see Warnings and Precautions (5.5) ] Pancreatic Enzymes Elevation [see Warnings and Precautions (5.6) ] Hepatotoxicity [see Warnings and Precautions (5.7) ] Hyperglycemia [see Warnings and Precautions (5.8) ] Photosensitivity [see Warnings and Precautions (5.9) ] The most common adverse reactions (≥25%) with ALUNBRIG were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, and dyspnea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-217-6468 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. …
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective January 12, 2026 (SPL set 0fe9ff20-d402-41f3-bc1e-7002ea7007db), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,630 reports list brigatinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 786 are coded as a death and 995 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 19 reactions below, 12 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?
- Brigatinib: 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