Abemaciclib Side Effects

For the Consumer

Applies to abemaciclib: oral tablet

Along with its needed effects, abemaciclib 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 abemaciclib:

• Black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• chest pain
• chills
• confusion
• cough
• decreased urination
• diarrhea
• difficulty breathing
• dizziness
• dry mouth
• fainting
• fever
• hoarseness
• increased heart rate
• irregular heartbeat
• lightheadedness
• lower back or side pain
• pain in the chest, groin, or legs, especially the calves
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• rapid breathing
• rapid weight gain
• severe, sudden headache
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• sunken eyes
• swollen glands
• thirst
• tingling of the hands or feet
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vision changes
• wrinkled skin

• Blurred vision
• clay-colored stools
• dark urine
• decreased appetite
• fast heartbeat
• general feeling of discomfort or illness
• itching
• loss of appetite
• nausea
• numbness or tingling in the face, arms, or legs
• rapid, shallow breathing
• severe headache
• skin rash
• stomach pain or tenderness
• swelling of the feet or lower legs
• thickening of bronchial secretions
• trouble speaking or walking
• vomiting
• yellow eyes or skin

Some side effects of abemaciclib 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:

• Change in taste
• dry mouth
• loss of taste
• loss or thinning of hair
• swelling or inflammation of the mouth

For Healthcare Professionals

Applies to abemaciclib: oral tablet

General

The most common adverse reactions reported (20% or greater incidence) were increased creatinine (98%), decreased white blood cell count (91%), diarrhea (90%), decreased neutrophil count (88%), anemia (84%), fatigue/asthenia (65%), nausea (64%), decreased lymphocyte count (63%), decreased platelet count (53%), neutropenia (46%), decreased appetite (45%), infections (43%), increased ALT (41%), abdominal pain (39%), increased AST (37%), vomiting (35%), leukopenia (28%), and thrombocytopenia (20%).^[Ref]

Renal

Very common (10% or more): Increased creatinine (98%)^[Ref]

Hematologic

Very common (10% or more): Decreased white blood cell count (91%), decreased neutrophil count (88%), anemia (84%), decreased lymphocyte count (63%), decreased platelet count (53%), neutropenia (46%), leukopenia (28%), thrombocytopenia (20%)
Common (1% to 10%): Febrile neutropenia
Frequency not reported: Neutropenic sepsis^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (90%), nausea (64%), abdominal pain (39%), vomiting (35%), constipation (17%), stomatitis (15%), dry mouth (14%)^[Ref]

Other

Very common (10% or more): Fatigue/asthenia (65%), infections (43%), peripheral edema (12%), pyrexia (11%)^[Ref]

Reported infections included upper respiratory tract infection, urinary tract infection, lung infection, pharyngitis, conjunctivitis, sinusitis, vaginal infection, and sepsis.^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (45%), decreased weight (14%), dehydration (10%)^[Ref]

Hepatic

Very common (10% or more): Increased ALT (41%), increased AST (37%)^[Ref]

Respiratory

Very common (10% or more): Cough (19%)^[Ref]

Nervous system

Very common (10% or more): Headache (20%), dysgeusia (18%), dizziness (12%)^[Ref]

Dermatologic

Very common (10% or more): Alopecia (16%), pruritus (13%), rash (11%)^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (15%)^[Ref]

Cardiovascular

Common (1% to 10%): Venous thromboembolic events^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer