What the label lists and what reports show
Sotorasib side effects
Sotorasib's FDA label: “The most common adverse reactions (≥ 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.” FAERS holds 3,319 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 (325 reports).
- No generic listed
Check it at the source: the sotorasib FDA label on DailyMed (effective January 22, 2025); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of LUMAKRAS?LUMAKRAS may cause serious side effects, including: Liver problems. Abnormal liver blood tests are common with LUMAKRAS and can sometimes be severe. Your healthcare provider should do blood tests before starting and during treatment with LUMAKRAS to check your liver function. Tell your healthcare provider right away if you develop any signs or symptoms of liver problems, including: your skin or the white part of your eyes turns yellow (jaundice) dark or "tea-colored" urine light-colored stools (bowel movements) tiredness or weakness nausea or vomiting bleeding or bruising loss of appetite pain, aching, or tenderness on the right side of your stomach-area (abdomen) Lung or breathing problems. LUMAKRAS may cause inflammation of the lungs that can lead to death. […]
Source: FDA drug label, Amgen Inc, effective January 22, 2025 (SPL set c80a362c-7ac3-4894-a076-0691e68ef8c1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.
Table 5. Adverse Reactions (≥ 10%) in Patients with KRAS G12C-Mutated mCRC who Received LUMAKRAS 960 mg in Combination with Panitumumab in CodeBreaK 300
| Reaction | All Grades (%) | Grade 3 or 4 (%) | All Grades (%) | Grade 3 or 4 (%) |
|---|---|---|---|---|
| Rash Rash includes dermatitis acneiform, dermatosis, drug eruption, eczema, erythema,… | 87 | 26 | 8 | 2 |
| Dry skin Dry skin includes dry skin, xerosis, and xeroderma. | 28 | 0 | 2 | 0 |
| Pruritis | 17 | 0 | 4 | 0 |
| Nail Disorder Nail disorders includes nail avulsion, nail cuticle fissure, nail disorder,… | 17 | 0 | 0 | 0 |
| Skin fissure | 13 | 0 | 0 | 0 |
| Palmar-plantar erythrodysesthesia syndrome | 13 | 0 | 10 | 4 |
| Diarrhea Diarrhea includes diarrhea, gastroenteritis, and diarrhea hemorrhagic. | 28 | 6 | 26 | 0 |
| Stomatitis Stomatitis includes mucosal inflammation, stomatitis, mouth ulceration,… | 26 | 0 | 14 | 0 |
| Nausea | 17 | 2.1 | 36 | 4 |
| Constipation | 15 | 2.1 | 10 | 0 |
| Abdominal pain Abdominal pain includes abdominal pain, abdominal pain upper, abdominal… | 15 | 0 | 18 | 2 |
| Vomiting | 13 | 2.1 | 10 | 2 |
| Fatigue Fatigue includes asthenia and fatigue. | 21 | 0 | 34 | 2 |
| Musculoskeletal pain Musculoskeletal pain includes arthralgia, back pain, myalgia,… | 21 | 2.1 | 14 | 2 |
| Hemorrhage Hemorrhage includes epistaxis, gastrointestinal hemorrhage, vaginal… | 13 | 2.1 | 2 | 0 |
| Conjunctivitis Conjunctivitis includes conjunctival hyperemia, conjunctivitis, and… | 11 | 0 | 2 | 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 discussed in greater detail in other sections of the labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ] Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.2) ] Single agent in NSCLC: The most common adverse reactions (≥ 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. The most common laboratory abnormalities (≥ 25%) were decreased lymphocytes, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium. ( 6.1 ) In combination with panitumumab in CRC: The most common adverse reactions (≥ 20%) in clinical trials of LUMAKRAS in combination with panitumumab are rash, dry skin, diarrhea, stomatitis, fatigue and musculoskeletal pain. The most common Grade 3 or 4 laboratory abnormalities in ≥ 2 patients (4.3%) were decreased magnesium, decreased potassium, decreased corrected calcium, and increased potassium. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Amgen Inc, effective January 22, 2025 (SPL set c80a362c-7ac3-4894-a076-0691e68ef8c1), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,319 reports list sotorasib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 788 are coded as a death and 670 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. Reports rose sharply in 2023 (1,226, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 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?
- Sotorasib: 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