What the label lists and what reports show
Adagrasib side effects
Adagrasib's FDA label: “The most common adverse reactions (≥ 25%) were nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal impairment, edema, dyspnea, and decreased appetite.” FAERS holds 1,063 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 (128 reports).
- No generic listed
Check it at the source: the adagrasib FDA label on DailyMed (effective March 25, 2026, Mirati Therapeutics, 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 KRAZATI?KRAZATI can cause serious side effects, including: o Stomach and intestinal (gastrointestinal) problems. Stomach and intestinal side effects including nausea, diarrhea, or vomiting, are common with KRAZATI but can also sometimes be severe. KRAZATI can also cause serious stomach and intestinal side effects such as bleeding, obstruction, inflammation of the colon (colitis), and narrowing (stenosis). o Call your healthcare provider if you develop any of the signs or symptoms of stomach or intestinal problems listed above during treatment with KRAZATI . o Your healthcare provider may prescribe an antidiarrheal medicine or anti-nausea medicine, or other treatment, as needed. o Changes in the electrical activity of your heart called QTc prolongation. […]
Source: FDA drug label, NDA216340 (Bristol), as published by Mirati Therapeutics, Inc, effective March 25, 2026 (SPL set 0b8bf078-34c2-4f45-9012-38a8ac082b01), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 25%) were nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal impairment, edema, dyspnea, and decreased appetite.
Table 5: Adverse Reactions (≥ 20 %) in Patients with KRAS G12C-mutated CRC Received Adagrasib in Combination with Cetuximab in KRYSTAL-1
| Reaction | Adverse Reaction Graded per CTCAE version 5.0. All Grades (%) | Adagrasib in Combination with Cetuximab N = 94 Grade 3 or 4 (%) |
|---|---|---|
| Rash Grouped term; includes multiple related terms. | 84 | 4.3 |
| Dry skin | 36 | 0 |
| Nausea | 68 | 2.1 |
| Diarrhea | 65 | 5 |
| Vomiting | 57 | 0 |
| Abdominal pain | 30 | 4.3 |
| Constipation | 23 | 0 |
| Fatigue | 57 | 3.2 |
| Musculoskeletal pain | 47 | 4.3 |
| Edema | 28 | 0 |
| Hepatotoxicity | 38 | 10 |
| Headache | 37 | 4.3 |
| Dizziness | 24 | 2.1 |
| Peripheral neuropathy | 20 | 1.1 |
| Decreased appetite | 30 | 0 |
| Anemia | 27 | 7 |
| Cough | 25 | 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: • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.1) ] • QTc Interval Prolongation [see Warnings and Precautions (5.2) ] • Hepatotoxicity [see Warnings and Precautions (5.3) ] • Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.4) ] • Single agent use in NCSLC: The most common adverse reactions (≥ 25%) were nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal impairment, edema, dyspnea, and decreased appetite. The most common (≥ 2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, decreased hemoglobin, increased alanine aminotransferase, increased aspartate aminotransferase, hypokalemia, hyponatremia, increased lipase, decreased leukocytes, decreased neutrophils and increased alkaline phosphatase. ( 6.1 ) • In combination with cetuximab in CRC: The most common adverse reactions (≥ 25%) were rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, and cough. …
Source: FDA drug label, NDA216340 (Bristol), as published by Mirati Therapeutics, Inc, effective March 25, 2026 (SPL set 0b8bf078-34c2-4f45-9012-38a8ac082b01), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,063 reports list adagrasib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 341 are coded as a death and 401 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 21 reactions below, 13 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?
- Adagrasib: 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