Cobimetinib: uses, dosing, side effects & brands

Cobimetinib is a kinase inhibitor sold in the U.S. under one brand, for melanoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Kinase Inhibitor
Treats: Melanoma
Available as: Tablet
Sold as: Cotellic
Prescription?: Prescription only
Generic available?: Not in our catalog

How cobimetinib is dosed

From the FDA label for Cotellic (application NDA206192). Other cobimetinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of COTELLIC with vemurafenib for patients with melanoma. ( 2.1 ) The recommended dose is 60 mg orally once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity. Take COTELLIC with or without food. ( 2.2 ) 2.1 Patient Selection for Treatment of Melanoma Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with COTELLIC with vemurafenib. Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics . 2.2 Recommended Dosage The recommended dosage regimen of COTELLIC is 60 mg (three 20 mg tablets) orally taken once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity [see Clinical Studies (14) ] . Take COTELLIC with or without food [see Clinical Pharmacology (12.3) ] . If a dose of COTELLIC is missed or if vomiting occurs when the dose is taken, resume dosing with the next scheduled dose. 2.3 Dose Modifications Concurrent CYP3A Inhibitors Do not take strong or moderate CYP3A inhibitors while taking COTELLIC. If concurrent short term (14 days or less) use of moderate CYP3A inhibitors is unavoidable for patients who are taking COTELLIC 60 mg, reduce COTELLIC dose to 20…

Cobimetinib side effects

The following adverse reactions are discussed in greater detail in other sections of the label: New Primary Cutaneous Malignancies [see Warnings and Precautions (5.1) ] Hemorrhage [see Warnings and Precautions (5.2) ] Cardiomyopathy [see Warnings and Precautions (5.3) ] Serious Dermatologic Reactions [see Warnings and Precautions (5.4) ] Serous Retinopathy and Retinal Vein Occlusion [see Warnings and Precautions (5.5) ] Hepatotoxicity [see Warnings and Precautions (5.6) ] Rhabdomyolysis [see Warnings and Precautions (5.7) ] Severe Photosensitivity [see Warnings and Precautions (5.8) ] Unresectable or Metastatic Melanoma: Most common adverse reactions for COTELLIC (≥20%) are diarrhea, photosensitivity reaction, nausea, pyrexia, and vomiting. The most common (≥5%) Grade 3-4 laboratory abnormalities are increased GGT, increased CPK, hypophosphatemia, increased ALT, lymphopenia, increased AST, increased alkaline phosphatase, hyponatremia. ( 6.1 ) Histiocytic neoplasms: Most common adverse reactions (≥20%) are acneiform dermatitis, diarrhea, infection, fatigue, nausea, edema, dry skin, maculopapular rash, pruritus, dyspepsia, vomiting, dyspnea and urinary tract infections. The most common (≥5%) grade 3-4 lab abnormalities include: Hyponatremia, increased blood creatine phosphokinase, hypokalemia, increased blood creatinine, increased AST, hypocalcemia, lymphopenia, leukopenia,…

Who shouldn’t take cobimetinib

None. None. ( 4 )

Cobimetinib drug interactions

Avoid concomitant administration of COTELLIC with strong or moderate CYP3A inducers or inhibitors. ( 2.3 , 7.1 , 7.2 ) 7.1 Effect of Strong or Moderate CYP3A Inhibitors on COTELLIC Coadministration of COTELLIC with itraconazole (a strong CYP3A4 inhibitor) increased cobimetinib systemic exposure by 6.7-fold. Avoid concurrent use of COTELLIC and strong or moderate CYP3A inhibitors. If concurrent short term (14 days or less) use of moderate CYP3A inhibitors including certain antibiotics (e.g., erythromycin, ciprofloxacin) is unavoidable for patients who are taking COTELLIC 60 mg, reduce COTELLIC dose to 20 mg. After discontinuation of a moderate CYP3A inhibitor, resume COTELLIC at the previous dose [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ] . Use an alternative to a strong or moderate CYP3A inhibitor in patients who are taking a reduced dose of COTELLIC (40 or 20 mg daily) [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ] . 7.2 Effect of Strong or Moderate CYP3A Inducers on COTELLIC Coadministration of COTELLIC with a strong CYP3A inducer may decrease cobimetinib systemic exposure by more than 80% and reduce its efficacy. Avoid concurrent use of COTELLIC and strong or moderate CYP3A inducers including but not limited to carbamazepine, efavirenz, phenytoin, rifampin, and St. John's Wort [see Clinical Pharmacology (12.3) ] .

Every cobimetinib 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: Cotellic.

Cobimetinib and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

No information is available on the clinical use of cobimetinib during breastfeeding. Because cobimetinib is 90% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 44 hours, and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during cobimetinib therapy and for 2 weeks after the last dose.

Full LactMed record for cobimetinib: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised July 15, 2025. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about cobimetinib

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 3 reports naming cobimetinib, 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:

acrochordon1 reports
atrial fibrillation1 reports
diarrhoea1 reports
dizziness1 reports
dyspepsia1 reports
ejection fraction decreased1 reports
headache1 reports
malignant melanoma1 reports

Read these as a signal, not a rate. A report does not mean cobimetinib 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.

Source: openFDA drug/event (FAERS), retrieved September 25, 2026.

Related calculators

How long it stays in your system →

Frequently asked questions

What is cobimetinib?

Cotellic (Cobimetinib Fumarate) is a kinase inhibitor used to treat Melanoma.

What kind of drug is cobimetinib?

The FDA classifies cobimetinib as a kinase inhibitor. Kinase inhibitors block protein kinases, the enzymes that relay 'grow and divide' signals inside cells. By shutting down the overactive kinase signals that a tumor depends on, they help slow or stop cancer cells from multiplying. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take cobimetinib 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 cobimetinib 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 cobimetinib come in?

Across the brands we track, cobimetinib is currently marketed as 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 cobimetinib?

We do not currently list a generic-labelled cobimetinib 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). Cobimetinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/cobimetinib
MLA: “Cobimetinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/cobimetinib.

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 cobimetinib on DailyMed (NIH) ↗.