Mirdametinib: uses, dosing, side effects & brands
Mirdametinib is a medicine sold in the U.S. under one brand, for plexiform neurofibroma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats (across its forms)
- Plexiform Neurofibroma
- Available as
- Capsule · Tablet
- Sold as
- Gomekli
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How mirdametinib is dosed
From the FDA label for Gomekli (application NDA219389). Other mirdametinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dosage of GOMEKLI is 2 mg/m 2 orally twice daily, with or without food, for the first 21 days of each 28-day cycle. Continue treatment with GOMEKLI until disease progression or unacceptable toxicity. ( 2 ) 2.1 Recommended Evaluation and Testing Before Initiating GOMEKLI Prior to administration of GOMEKLI: conduct comprehensive ophthalmic assessment [see Warnings and Precautions (5.1) ]. assess ejection fraction (EF) by echocardiogram [see Warnings and Precautions (5.2) ]. 2.2 GOMEKLI Dosage Form Overview GOMEKLI is available in 2 dosage forms: capsules or tablets for oral suspension. GOMEKLI capsules: must be swallowed whole, do not open, break or chew capsules. GOMEKLI tablets for oral suspension: can be swallowed whole or can be dispersed in drinking water and administered orally as a liquid [see Dosage and Administration (2.4) ]. 2.3 Recommended Dosage The recommended dosage of GOMEKLI is 2 mg/m 2 orally twice daily (approximately every 12 hours) with or without food for the first 21 days of each 28-day cycle. The maximum dose is 4 mg twice daily. Continue treatment with GOMEKLI until disease progression or unacceptable toxicity. The recommended dose of GOMEKLI is based on body surface area (BSA) as shown in Table 1. Table 1: Recommended Dosage for GOMEKLI Body Surface Area (m 2 ) * Recommended Dosage for Capsules or Tablets for Oral Suspension 0.40 to 0.69…
Mirdametinib side effects
The following serious adverse reactions are described elsewhere in the labeling: Ocular Toxicity [see Warnings and Precautions (5.1) ] Left Ventricular Dysfunction [see Warnings and Precautions (5.2) ] Dermatologic Adverse Reactions [see Warnings and Precautions (5.3) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.4) ] Adults: The most common adverse reactions (>25%) were rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormality (>2%) was increased creatine phosphokinase. ( 6.1 ) Pediatric patients: The most common adverse reactions (>25%) were rash, diarrhea, musculoskeletal pain, abdominal pain, vomiting, headache, paronychia, left ventricular dysfunction, and nausea. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (>2%) were decreased neutrophil count and increased creatine phosphokinase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact SpringWorks Therapeutics Inc. at 1-888-400-7989 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the…
Who shouldn’t take mirdametinib
None. None. ( 4 )
Every mirdametinib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Gomekli.
What mirdametinib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Can you crush or split mirdametinib?
At least one mirdametinibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each mirdametinib label says about crushing, splitting and chewingWhat people report to the FDA about mirdametinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 11 reports naming mirdametinib, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- dehydration4 reports
- dermatitis acneiform4 reports
- diarrhoea3 reports
- nausea3 reports
- abdominal discomfort2 reports
- blindness unilateral2 reports
- constipation2 reports
- fatigue2 reports
Read these as a signal, not a rate. A report does not mean mirdametinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is mirdametinib?
Gomekli (Mirdametinib) is a medication used to treat Plexiform Neurofibroma.
Can you take mirdametinib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run mirdametinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does mirdametinib come in?
Across the brands we track, mirdametinib is currently marketed as capsule and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic mirdametinib?
We do not currently list a generic-labelled mirdametinib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Mirdametinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/mirdametinib
- MLA
- “Mirdametinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/mirdametinib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for mirdametinib on DailyMed (NIH) ↗.