Prescription medicine
Trametinib Brand names: Mekinist
Trametinib (Mekinist) is a prescription medicine with an FDA approval on record since 2013. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the trametinib FDA label on DailyMed (effective May 7, 2026, Novartis Pharmaceuticals Corporation); the NDA 204114 record on Drugs@FDA; every trametinib label on DailyMed.
Highlights of the record
FDA label of May 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
Forms and strengths
- 0.5 mg
- 2 mg
- 0.05 mg/ml
Film-coated tablet; powder for solution.
On the market
- Earliest approval on file
- May 29, 2013 Mekinist, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first August 6, 2024; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 28, 2034 Mekinist tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 24,023 through July 30, 2026
What is trametinib used for?
From the label: indications and usageMEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1 , 2.1 ) MEKINIST is indicated, in combination with dabrafenib, for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1 , 2.1 ) the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. […]
Conditions named in the indications of trametinib's FDA labels, with every medicine labeled for each:
From other trametinib labelsLung cancer: … resection. ( 1.2 , 2.1 ) the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. …
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Mekinist), Novartis Pharmaceuticals Corporation, effective May 7, 2026 (SPL set 0002ad27-779d-42ab-83b5-bc65453412a1), via openFDA; the full label on DailyMed
What does the patient leaflet for trametinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about MEKINIST?MEKINIST may cause serious side effects, including: Risk of new skin cancers. MEKINIST, when used with dabrafenib, may cause skin cancers, called cutaneous squamous cell carcinoma, keratoacanthoma, basal cell carcinoma, or melanoma. Talk to your healthcare provider about your risk for these cancers. Check your skin and tell your healthcare provider right away about any skin changes, including a: new wart skin sore or reddish bump that bleeds or does not heal change in size or color of a mole Your healthcare provider should check your skin before treatment with MEKINIST and dabrafenib, every 2 months during treatment with MEKINIST and dabrafenib, and for up to 6 months after you stop taking MEKINIST and dabrafenib to look for any new skin cancers. Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment with MEKINIST with dabrafenib. See "What are the possible side effects of MEKINIST?" for more information about side effects.
From the patient leaflet: How should I store MEKINIST?MEKINIST tablets: Store MEKINIST tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep MEKINIST tablets dry and away from moisture and light. The bottle of MEKINIST tablets contains a drying agent (desiccant packet) to help keep your medicine dry. Do not throw away (dispose of) the desiccant packet. Keep MEKINIST tablets in the original bottle. Do not place tablets in a pill box. Safely throw away MEKINIST tablets that are out of date or no longer needed. MEKINIST for oral solution: Store MEKINIST for oral solution in the original amber bottle at room temperature below 77°F (25°C). Do not freeze. Keep MEKINIST for oral solution in the carton it comes in and away from direct moisture and light. Throw away unused MEKINIST for oral solution after the expiration or “discard after” date written on the amber bottle label. […]
Source: FDA drug label (Mekinist), Novartis Pharmaceuticals Corporation, effective May 7, 2026 (SPL set 0002ad27-779d-42ab-83b5-bc65453412a1), via openFDA; the full label on DailyMed
Is there a generic for trametinib (Mekinist)?
The FDA approved the first generic trametinib on August 6, 2024. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 8 patents for Mekinist tablets: the compound patent runs to October 15, 2030 (pediatric exclusivity to April 15, 2031), and the last listed entry to February 28, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2024 first generic approved
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the trametinib label say about other medicines?
The trametinib label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name trametinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dabrafenib | drug interactions | Refer to the dabrafenib prescribing information for additional risk information that applies to combination use treatment. |
| Prednisone | warnings and precautions | Administer corticosteroids (e.g., prednisone 10 mg daily) for at least 5 days for second or subsequent pyrexia if temperature does not return to baseline within 3 days of onset of pyrexia, or for pyrexia associated with complications, such as dehydration, hypotension, renal failure, or severe chills/rigors, and there … |
Source: FDA drug label (Mekinist), 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 for trametinib?
The FDA Adverse Event Reporting System holds 24,023 reports that list trametinib among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as trametinib?
26 other medicines are given the same way (oral) and in the same FDA class as trametinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Lorlatinib | Lung cancer | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as trametinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to trametinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Trametinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other