What the label lists and what reports show
Binimetinib side effects
Binimetinib's FDA label: “Most common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, vomiting, and abdominal pain.” FAERS holds 7,756 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 nausea (715 reports).
- No generic listed
Check it at the source: the binimetinib FDA label on DailyMed (effective March 20, 2025, Array BioPharma 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 MEKTOVI?MEKTOVI may cause serious side effects, including: • Heart problems, including heart failure. MEKTOVI, when taken with encorafenib, can cause heart problems. Your healthcare provider should check your heart function before and during treatment with MEKTOVI. Call your healthcare provider right away if you have any of the following signs and symptoms of a heart problem: o feeling like your heart is pounding or racing o shortness of breath o swelling of your ankles and feet o feeling lightheaded • Blood clots. MEKTOVI, when taken with encorafenib, can cause blood clots in your arms or legs, which can travel to your lungs and can lead to death. Get medical help right away if you have the following symptoms: o chest pain o sudden shortness of breath or trouble breathing o pain in your legs with or without swelling o swelling in your arms and legs o a cool pale arm or leg • Eye problems. […]
Source: FDA drug label, Array BioPharma Inc., effective March 20, 2025 (SPL set 6c3408ac-d401-4925-8a03-26591afbc240), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, vomiting, and abdominal pain.
Table 5: Adverse Reactions Occurring in ≥10% of Patients Receiving MEKTOVI in Combination with Encorafenib in PHAROS Grades per National Cancer Institute CTCAE v4.03.
| Reaction | Adverse Reaction All Grades (%) | MEKTOVI with encorafenib N=98 Grade 3 and 4 One Grade 5 adverse reaction of hemorrhage occurred. (%) |
|---|---|---|
| Fatigue Fatigue includes fatigue, asthenia. | 61 | 8 |
| Edema Edema includes edema peripheral, generalized edema, swelling, localized edema, face… | 23 | 1 |
| Pyrexia | 22 | 0 |
| Nausea | 58 | 3.1 |
| Diarrhea Diarrhea includes diarrhea, colitis. | 52 | 7 |
| Vomiting | 37 | 1 |
| Abdominal pain Abdominal pain includes abdominal pain, abdominal pain upper, abdominal… | 32 | 1 |
| Constipation | 27 | 0 |
| Visual impairment Visual impairment includes vision blurred, visual impairment, vitreous… | 29 | 2 |
| Musculoskeletal pain Musculoskeletal pain includes back pain, arthralgia, pain in… | 48 | 4.1 |
| Rash Rash includes rash, rash macular, rash maculo-papular, rash papular, rash… | 27 | 3.1 |
| Pruritis Pruritis includes pruritus, pruritus genital. | 16 | 0 |
| Dry skin | 13 | 0 |
| Alopecia | 12 | 0 |
| Dyspnea Dyspnea includes dyspnea, dyspnea exertional. | 27 | 8 |
| Cough Cough includes cough, productive cough. | 26 | 0 |
| Dizziness Dizziness includes dizziness, balance disorder. | 17 | 1 |
| Headache | 11 | 0 |
| Decreased appetite | 14 | 1 |
| Hemorrhage Hemorrhage includes anal hemorrhage, hemothorax, gastrointestinal hemorrhage,… | 12 | 4.1 |
| Hypertension | 10 | 5 |
| Left ventricular dysfunction/cardiomyopathy Left ventricular dysfunction/cardiomyopathy… | 11 | 1 |
| Weight increased | 11 | 1 |
| Insomnia | 10 | 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 described elsewhere in the labeling: • New Primary Malignancies [see Warnings and Precautions (5.1) ] • Cardiomyopathy [see Warnings and Precautions (5.2) ] • Venous Thromboembolism [see Warnings and Precautions (5.3) ] • Ocular Toxicities [see Warnings and Precautions (5.4) ] • Interstitial Lung Disease [see Warnings and Precautions (5.5) ] • Hepatotoxicity [see Warnings and Precautions (5.6) ] • Rhabdomyolysis [see Warnings and Precautions (5.7) ] • Hemorrhage [see Warnings and Precautions (5.8) ] • Embryo-Fetal Toxicity [see Warnings and Precautions (5.9) ] • Risks Associated with Combination Treatment [see Warnings and Precautions (5.10) ] Melanoma: Most common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, vomiting, and abdominal pain. ( 6.1 ) NSCLC: Most common adverse reactions (≥25%) for MEKTOVI, in combination with encorafenib, are fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Array BioPharma Inc., effective March 20, 2025 (SPL set 6c3408ac-d401-4925-8a03-26591afbc240), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,756 reports list binimetinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,209 are coded as a death and 2,258 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, 16 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?
- Binimetinib: 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