Ensacove Side Effects

Generic name: ensartinib

Note: This document provides detailed information about Ensacove Side Effects associated with ensartinib. Some dosage forms listed on this page may not apply specifically to the brand name Ensacove.

Applies to ensartinib: oral capsule.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• muscle pain, tenderness, or weakness;

• slow heart rate, dizziness, a light-headed feeling, like you might pass out;

• lung problems--trouble breathing, shortness of breath, cough with or without mucus, chest pain, fever;

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• skin problems--skin rash, itching, skin swelling;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• vision changes--blurred or double vision, seeing flashes of light or "floaters" in your vision, eyes being more sensitive to light; or

• high levels of uric acid in blood--joint problems, stomach pain, little or no urination, nausea, vomiting, pink or brown urine.

Common side effects may include:

• cough;

• skin rash, itching, skin swelling;

• bone or muscle pain;

• tiredness, fever;

• constipation, nausea or vomiting;

• abnormal liver function tests;

• low white blood cell counts;

• low red blood cells (anemia); or

• other abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

See also:

For healthcare professionals

Applies to ensartinib: oral capsule.

General adverse events

The most common adverse reactions and laboratory abnormalities occurring in 30% of patients or greater included rash, musculoskeletal pain, constipation, pruritus, cough, decreased lymphocytes, decreased hemoglobin, increased ALT, increased AST, increased glucose, decreased phosphate, increased urate, decreased calcium, increased alkaline phosphatase, decreased albumin, increased creatinine phosphokinase, and increased creatinine.^[Ref]

Cardiovascular

• Common (1% to 10%): Bradycardia

Dermatologic

• Very common (10% or more): Rash (up to 72%), pruritus (up to 32%), alopecia (up to 11%), dry skin (up to 10%)
• Common (1% to 10%): Cellulitis
• Uncommon (0.1% to 1%): Photosensitivity, drug reaction with eosinophilia and systemic symptoms (DRESS)

Rash included dermatitis, acneiform dermatitis, bullous dermatitis, drug eruption, eczema, exfoliative rash, palmar-plantar erythrodysesthesia, rash, erythematous rash, generalized rash, macular rash, maculopapular rash, morbilliform rash, papular rash, pruritic rash, pustular rash, skin exfoliation, and vulvovaginal rash.

Pruritus included pruritus of the ear, eye, eyelids, and lip, and generalized pruritus.

Gastrointestinal

• Very common (10% or more): Constipation (up to 31%), nausea (up to 28%), vomiting/retching (up to 16%)
• Common (1% to 10%): Increased amylase

Hematologic

• Very common (10% or more): Decreased lymphocytes (up to 57%), decreased hemoglobin (up to 43%), hemorrhage (up to 10%)

Hemorrhage included hemoptysis, intracranial hemorrhage, gastrointestinal hemorrhage, hematuria, upper gastrointestinal hemorrhage, vaginal hemorrhage, gingival bleeding, vitreous hemorrhage, epistaxis, rectal hemorrhage, and anal hemorrhage.

Hepatic

• Very common (10% or more): Increased ALT (up to 73%), increased AST (up to 64%), increased bilirubin (up to 12%)
• Common (1% to 10%): Increased conjugated bilirubin, increased GGT
• Frequency not reported: Drug-induced liver injury

Metabolic

• Very common (10% or more): Increased glucose (up to 49%), decreased phosphate (up to 39%), increased urate (up to 39%), decreased calcium (up to 36%), decreased sodium (up to 27%), decreased appetite (up to 15%)
• Common (1% to 10%): Increased uric acid, hyperuricemia, increased magnesium, decreased potassium

Musculoskeletal

• Very common (10% or more): Increased creatinine phosphokinase (up to 43%), musculoskeletal pain (up to 36%)

Musculoskeletal pain included arthritis, spinal pain, myalgia, back pain, pain in extremity, neck pain, arthralgia, noncardiac chest pain, bone pain, musculoskeletal chest pain, and musculoskeletal discomfort.

Nervous system

• Very common (10% or more): Dizziness (up to 12%), dysgeusia (up to 10%)

Dizziness also included vertigo and postural dizziness.

Ocular

• Common (1% to 10%): Visual disturbances

Other

• Very common (10% or more): Increased alkaline phosphatase (up to 64%), decreased albumin (up to 46%), edema (up to 27%), pyrexia (up to 22%), fatigue (up to 21%)

Edema included edema of the eyelid, eye, periorbital area, face, and skin, as well as generalized, localized, peripheral, and gravitational edema.

Pyrexia also included hyperthermia.

Fatigue also included asthenia.

Renal

• Very common (10% or more): Increased creatinine (up to 37%)

Respiratory

• Very common (10% or more): Cough (up to 31%), respiratory tract infection (up to 13%)
• Common (1% to 10%): Pneumonia, pneumonitis/interstitial lung disease
• Uncommon (0.1% to 1%): Bronchopneumonia

Cough also included upper-airway cough syndrome and productive cough.

Further information

Ensacove 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.

Medical Disclaimer