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Verzenio Side Effects

Generic Name: abemaciclib

Note: This document contains side effect information about abemaciclib. Some of the dosage forms listed on this page may not apply to the brand name Verzenio.

For the Consumer

Applies to abemaciclib: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
  • Very loose stools (diarrhea).
  • Loose stools (diarrhea) that will not go away.
  • Feeling very tired or weak.
  • Any unexplained bruising or bleeding.
  • Fast breathing.
  • A fast heartbeat.
  • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Loose stools (diarrhea).
  • Feeling tired or weak.
  • Upset stomach or throwing up.
  • Not hungry.
  • Belly pain.
  • Headache.
  • Hard stools (constipation).
  • Dry mouth.
  • Mouth irritation or mouth sores.
  • Joint pain.
  • Change in taste.
  • Dizziness.
  • Hair loss.
  • Weight loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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]

References

1. "Product Information. Verzenio (abemaciclib)." Lilly, Eli and Company, Indianapolis, IN.

Some side effects of Verzenio may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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