What the label lists and what reports show
Trametinib side effects
Trametinib's FDA label: “Most common adverse reactions (≥ 20%) for MEKINIST as a single agent include rash, diarrhea, and lymphedema.” FAERS holds 24,023 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 pyrexia (4,068 reports).
- No generic listed
Check it at the source: the trametinib FDA label on DailyMed (effective May 7, 2026, Novartis Pharmaceuticals Corporation); 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 MEKINIST?MEKINIST may cause serious side effects, including: See “What is the most important information I should know about MEKINIST?” bleeding problems. MEKINIST can cause serious bleeding problems, especially in your brain or stomach, that can lead to death. Call your healthcare provider and get medical help right away if you have any signs of bleeding, including: ○ headaches, dizziness, or feeling weak ○ cough up blood or blood clots ○ vomit blood or your vomit looks like “coffee grounds” ○ red or black stools that look like tar inflammation of the intestines, or tears (perforation) of the stomach or intestines. MEKINIST can cause inflammation of your intestines, or tears in the stomach or intestines that can lead to death. Tell your healthcare provider right away if you have any of the following symptoms: ○ bleeding. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective May 7, 2026 (SPL set 0002ad27-779d-42ab-83b5-bc65453412a1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 20%) for MEKINIST as a single agent include rash, diarrhea, and lymphedema.
Table 12. Adverse Reactions Occurring in ≥ 20% (All Grades) of Patients Treated with MEKINIST plus Dabrafenib in Study BRF113928 a
| Reaction | Adverse Reactions All Grades (%) | MEKINIST plus Dabrafenib N = 93 Grades 3 and 4 (%) |
|---|---|---|
| Pyrexia | 55 | 5 |
| Fatigue b | 51 | 5 |
| Edema c | 28 | 0 |
| Chills | 23 | 1.1 |
| Nausea | 45 | 0 |
| Vomiting | 33 | 3.2 |
| Diarrhea | 32 | 2.2 |
| Decreased appetite | 29 | 0 |
| Dry skin | 31 | 1.1 |
| Rash d | 28 | 3.2 |
| Hemorrhage e | 23 | 3.2 |
| Cough | 22 | 0 |
| Dyspnea | 20 | 5 |
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: New Primary Malignancies [see Warnings and Precautions ( 5.1)] Hemorrhage [see Warnings and Precautions (5.2)] Colitis and Gastrointestinal Perforation [see Warnings and Precautions (5.3)] Venous Thromboembolic Events [see Warnings and Precautions (5. 4 )] Cardiomyopathy [see Warnings and Precautions (5. 5 )] Ocular Toxicities [see Warnings and Precautions (5. 6 )] Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5. 7 )] Serious Febrile Reactions [see Warnings and Precautions (5. 8 )] Serious Skin Toxicities [see Warnings and Precautions (5. 9 )] Hyperglycemia [see Warnings and Precautions (5. 10 )] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5. 12 )] There are additional adverse reactions associated with dabrafenib. Refer to the dabrafenib prescribing information for additional information. Most common adverse reactions (≥ 20%) for MEKINIST as a single agent include rash, diarrhea, and lymphedema. ( 6.1 ) Most common adverse reactions (≥ 20%) for MEKINIST in combination with dabrafenib include: Unresectable or metastatic melanoma: pyrexia, nausea, rash, chills, diarrhea, vomiting, hypertension, and peripheral edema. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective May 7, 2026 (SPL set 0002ad27-779d-42ab-83b5-bc65453412a1), via openFDA; the full label on DailyMed
What do FAERS reports show?
24,023 reports list trametinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,130 are coded as a death and 6,535 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, 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?
- Trametinib: 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