Cotellic Side Effects

Generic name: cobimetinib

Medically reviewed by Drugs.com. Last updated on May 26, 2024.

Note: This document provides detailed information about Cotellic.

Applies to cobimetinib: oral tablet Side Effects associated with cobimetinib. Some dosage forms listed on this page may not apply specifically to the brand name Cotellic.

Applies to cobimetinib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 2 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Some men and women who use this medicine have become infertile (unable to have children). Talk to your doctor before using this medicine if you plan to have children.

This medicine may increase your risk of having cutaneous squamous cell carcinoma (cuSCC) or other skin cancers. Check with your doctor right away if you develop any skin changes, including a new wart, change in size or color of a mole, or a skin sore or reddish bump that does not heal. Your doctor may want your skin be checked for new skin lesions before treatment, during treatment, and for up to 6 months after the last dose.

This medicine may cause an increased sensitivity of the skin to sunlight (photosensitivity). Check with your doctor right away if you have itching, redness or other discoloration of the skin, severe sunburn, or skin rash. Use sunscreen or sunblock lotions with a sun protection factor (SPF) on a regular basis when you are outdoors. Wear protective clothing and hats.

This medicine may cause hemorrhage (severe bleeding) in the stomach and bowel areas or in the brain. Call your doctor right away if you have any unusual or unexplained bleeding.

This medicine may cause heart problems. Check with your doctor right away if you have chest discomfort or pain, dizziness or faintness, fast, irregular, or pounding heartbeat, swelling of the feet or lower legs, trouble with breathing, or unusual tiredness or weakness.

Call your doctor right away if you have a severe skin rash (especially if it covers a large area of your body), acne, or redness, blisters, swelling, peeling, or tenderness of the hands or feet. These may be symptoms of a serious skin reaction.

Check with your doctor right away if blurred vision, loss of vision, or any change in vision occurs during treatment. These could be symptoms of a serious eye problem. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Rhabdomyolysis (severe muscle problem) may occur while receiving this medicine. Tell your doctor right away if you have dark-colored urine, fever, muscle cramps, spasms, or pain, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Cotellic

Along with its needed effects, cobimetinib (the active ingredient contained in Cotellic) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cobimetinib:

Other side effects of Cotellic

Some side effects of cobimetinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to cobimetinib: oral tablet.

General adverse events

The most commonly reported adverse reactions (more than 35%) in patients treated for melanoma were increased creatinine, increased CPK, lymphopenia, increased AST, increased alkaline phosphatase, increased ALT, hypophosphatemia, anemia, increased gamma-glutamyltransferase, diarrhea, photosensitivity reactions, hypoalbuminemia, nausea, and hyponatremia.^[Ref]

Dermatologic

Very common (10% or more):

Unresectable or Metastatic Melanoma: Acneiform dermatitis (16%), alopecia (15%), erythema (10%), hyperkeratosis (11%), maculopapular rash, photosensitivity reactions (46%)

Histiocytic Neoplasms: Acneiform dermatitis (65%), dry skin (31%), maculo-papular rash (31%), pruritus (31%)^[Ref]

Gastrointestinal

Very common (10% or more):

Unresectable or Metastatic Melanoma: Diarrhea (60%), nausea (41%), stomatitis (14%), vomiting (24%)

Histiocytic Neoplasms: Diarrhea (62%), dry mouth (15%), dyspepsia (27%), nausea (46%), oral pain (15%), stomatitis (12%), vomiting (27%)^[Ref]

Cardiovascular

Very common (10% or more):

Unresectable or Metastatic Melanoma: Decreased left ventricular ejection fraction (26%), hypertension (15%)^[Ref]

Hematologic

Very common (10% or more):

Unresectable or Metastatic Melanoma: Lymphopenia (73%), anemia (69%), thrombocytopenia (18%), hemorrhage (e.g., rectal, hemorrhoidal, GI tract, uterine, vaginal, pulmonary, cerebral, subarachnoid, ocular, eye, conjunctival, retinal, reproductive system, melena, hematemesis, hematochezia, gingival bleeding, metrorrhagia, hemorrhagic ovarian cyst, menometrorrhagia, menorrhagia, hemoptysis, subgaleal hematoma, hematuria, epistaxis, contusion, traumatic hematoma, ecchymosis, purpura, nail bed bleeding)

Histiocytic Neoplasms: Hemorrhage (19%), hypertension (15%), lymphopenia (27%)

Common (1% to 10%):

Histiocytic Neoplasms: Anemia, neutropenia, leukopenia^[Ref]

Hepatic

Very common (10% or more):

Unresectable or Metastatic Melanoma: Increased aspartate aminotransferase (AST) (73%), increased alkaline phosphatase (71%), increased alanine aminotransferase (ALT) (68%), increased gamma-glutamyltransferase (65%)

Common (1% to 10%):

Histiocytic Neoplasms: Increased AST, increased ALT

• Frequency not reported: Increased total bilirubin^[Ref]

Metabolic

Very common (10% or more):

Unresectable or Metastatic Melanoma: Dehydration, hypophosphatemia (68%), hypoalbuminemia (42%), hyponatremia (38%), hyperkalemia (26%), hypokalemia (25%), hypocalcemia (24%)

Histiocytic Neoplasms: Hypokalemia (12%), hyponatremia (18%)

Common (1% to 10%):

Histiocytic Neoplasms: Hypocalcemia^[Ref]

Musculoskeletal

Very common (10% or more):

Unresectable or Metastatic Melanoma: Increased creatine phosphokinase (CPK) (79%)

Histiocytic Neoplasms: Increased CPK (27%)^[Ref]

Nervous system

Very common (10% or more):

Histiocytic Neoplasms: Headache (12%)

Ocular

Very common (10% or more):

Unresectable or Metastatic Melanoma: Vision impaired (e.g., vision blurred, visual acuity reduced, visual impairment) (15%), chorioretinopathy (e.g., retinal detachment, detachment of retinal pigment epithelium, detachment of macular retinal pigment epithelium) (13%), retinal detachment (e.g., retinal detachment, detachment of retinal pigment epithelium, detachment of macular retinal pigment epithelium) (12%)

Histiocytic Neoplasms: Vision blurred (12%)

Common (1% to 10%):

Unresectable or Metastatic Melanoma: Serious retinopathy (chorioretinopathy, retinal detachment)

Histiocytic Neoplasms: Retinal vascular disorder, retinopathy

Frequency not reported:

Unresectable or Metastatic Melanoma: Retinal vein occlusion^[Ref]

Oncologic

Common (1% to 10%):

Unresectable or Metastatic Melanoma: Cutaneous squamous cell carcinoma/keratoacanthoma, basal cell carcinoma

Uncommon (0.1% to 1%):

Unresectable or Metastatic Melanoma: Second primary melanoma, non-cutaneous malignancies^[Ref]

Other

Very common (10% or more):

Unresectable or Metastatic Melanoma: Pyrexia (28%), hemorrhage (13%), chills (10%)

Histiocytic Neoplasms: Decreased ejection fraction (19%), edema (42%), fall (15%), fatigue (42%), pain (15%)^[Ref]

Renal

Very common (10% or more):

Unresectable or Metastatic Melanoma: Increased creatinine (99.6%)

Histiocytic Neoplasms: Acute kidney injury (15%)^[Ref]

Respiratory

Very common (10% or more):

Histiocytic Neoplasms: Cough (15%), dyspnea (27%), hypoxia (12%), pulmonary infections (19%)

Common (1% to 10%):

Histiocytic Neoplasms: Pulmonary edema, respiratory failure

See also:

Frequently asked questions

• What is Cotellic used for?

Further information

Cotellic side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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