Summary

Commonly reported side effects of trametinib include: acneiform eruption, cardiomyopathy, decreased left ventricular ejection fraction, dermatitis, palmar-plantar erythrodysesthesia, skin rash, and erythema of skin. Other side effects include: cardiac failure. Continue reading for a comprehensive list of adverse effects.

Applies to trametinib: oral powder for solution, oral tablet.

Serious side effects of Trametinib

Along with its needed effects, trametinib 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 trametinib:

More common

• Bleeding from the rectum or bloody stools
• bleeding gums
• blemishes on the skin
• blistering, crusting, irritation, itching, or reddening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody nose
• blurred vision
• chest discomfort, pain, or tightness
• cracked, dry, or scaly skin
• coughing up blood
• decreased urine output
• diarrhea
• difficulty in moving
• difficulty with breathing or swallowing
• dilated neck veins
• extreme tiredness or weakness
• fast, slow, irregular, or pounding heartbeat
• headache
• increased menstrual flow or vaginal bleeding
• irregular breathing
• joint pain
• lightheadedness, dizziness, or fainting
• muscle aches, cramps, pain, or stiffness
• nervousness
• nosebleeds
• paralysis
• pimples
• pounding in the ears
• prolonged bleeding from cuts
• rapid weight gain
• rash
• red or black, tarry stools
• red or dark brown urine
• redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• swelling of the hands, ankles, feet, or lower legs
• tingling of the hands and feet
• ulceration of the skin
• unusual tiredness or weakness
• unusual weight gain or loss

Less common

• Cough
• fever

Rare

• Change in vision
• seeing flashes or sparks of light
• seeing floating spots before the eyes, or a veil or curtain across part of your vision
• stomach cramps, pain, or tenderness
• watery or bloody diarrhea

Incidence not known

• Blistering, peeling, loosening of the skin
• chills
• itching
• red skin lesions, often with a purple center
• sore throat
• sores, ulcers, or white spots in the mouth or on lips
• swollen glands
• unusual bleeding or bruising

Other side effects of Trametinib

Some side effects of trametinib 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:

More common

• Acne, pimples
• burning, itching, and pain in hairy areas, pus at the root of the hair
• canker sores
• change in taste
• dark urine
• dry eyes
• dry mouth
• dry skin
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• loosening of the fingernails
• loss of taste
• redness or soreness around the fingernails
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• swelling or inflammation of the mouth
• thirst

For Healthcare Professionals

Applies to trametinib: oral powder for reconstitution, oral tablet.

Cardiovascular

Very common (10% or more): Lymphedema/edema/peripheral edema (32%), hypertension (15%)

Common (1% to 10%): Left ventricular dysfunction, ejection fraction decreased, bradycardia, hypotension

Uncommon (0.1% to 1%): Cardiac failure, bradycardia

Frequency not reported: Myocarditis^[Ref]

Dermatologic

Very common (10% or more): Rash (57%), acneiform dermatitis (19%), dry skin (11%), pruritus (10%), paronychia (10%), alopecia, erythema

Common (1% to 10%): Cellulitis, pustular rash, palmar-plantar erythrodysesthesia syndrome, skin fissures, chapped skin, folliculitis, actinic keratosis, night sweats, hyperkeratosis, skin lesion, hyperhidrosis, panniculitis, photosensitivity reaction

Uncommon (0.1% to 1%): Acrochordon (skin tags)^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (43%), stomatitis (15%), abdominal pain (13%), nausea, vomiting, dry mouth, constipation

Common (1% to 10%): Mucosal inflammation, stomatitis

Uncommon (0.1% to 1%): GI perforation, colitis, pancreatitis

Frequency not reported: Hematochezia, rectal hemorrhage, melena, gingival bleeding, hemorrhoidal hemorrhage^[Ref]

Hematologic

Very common (10% or more): Hemorrhage (13%), neutropenia

Common (1% to 10%): Anemia, thrombocytopenia, leukopenia^[Ref]

Hepatic

Very common (10% or more): Aspartate aminotransferase increased

Common (1% to 10%): Alanine aminotransferase increased^[Ref]

Metabolic

Very common (10% or more): Decreased appetite

Common (1% to 10%): Dehydration, blood alkaline phosphatase increased, blood creatine phosphokinase increased, hyperglycemia^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia, myalgia, pain in extremity, muscle spasms

Uncommon (0.1% to 1%): Rhabdomyolysis^[Ref]

Nervous system

Very common (10% or more): Headache, dizziness^[Ref]

Ocular

Common (1% to 10%): Blurred vision, periorbital edema, visual impairment

Uncommon (0.1% to 1%): Chorioretinopathy, papilledema, retinal detachment, retinal vein occlusion

Frequency not reported: Conjunctival hemorrhage^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity^[Ref]

Immunologic

Common (1% to 10%): Influenza-like illness^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection

Frequency not reported: Vaginal hemorrhage, hematuria^[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis, cough

Common (1% to 10%): Pneumonitis, dyspnea

Uncommon (0.1% to 1%): Interstitial lung disease

Frequency not reported: Epistaxis^[Ref]

Other

Very common (10% or more): Fatigue, peripheral edema, chills, asthenia, pyrexia

Common (1% to 10%): Face edema, asthenia^[Ref]

Renal

Common (1% to 10%): Renal failure

Uncommon (0.1% to 1%): Nephritis^[Ref]