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Osimertinib Side Effects

In Summary

Commonly reported side effects of osimertinib include: cough. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to osimertinib: oral tablet

As well as its needed effects, osimertinib may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking osimertinib, check with your doctor immediately:

More common:
  • Anxiety
  • cough
  • dizziness, lightheadedness, or fainting
  • eye or vision changes
  • fast, pounding, or uneven heartbeat
  • pain in the chest, groin, or legs, especially the calves
  • pain, redness, or swelling in the arm or leg
  • shortness of breath or troubled breathing
  • slurred speech
  • sudden loss of coordination
  • sudden, severe headache
  • sudden, severe weakness or numbness in the arm or leg
Less common:
  • Blurred vision
  • fever or chills
  • general feeling of discomfort or illness
  • inability to speak
  • seizures
  • sneezing
  • sore throat
  • sudden, severe weakness on one side of the body
  • temporary blindness
  • thickening of bronchial secretions

Minor Side Effects

Some osimertinib side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Back pain
  • changes in the fingernails or toenails, including brittleness, inflammation, pain, redness, tenderness, separation from nail bed, or shedding of nails
  • constipation
  • decreased appetite
  • diarrhea
  • headache
  • nausea
  • skin rash, dryness, or itching
  • swelling or inflammation of the mouth
  • unusual tiredness or weakness

For Healthcare Professionals

Applies to osimertinib: oral tablet

General

-The most common (more than 30%) adverse reactions were lymphopenia, thrombocytopenia, anemia, diarrhea, rash, neutropenia, and dry skin.
-1% or less of patients developed fatal adverse reactions of interstitial lung disease (ILD)/pneumonitis, pneumonia, and cerebrovascular accident (CVA)/cerebral hemorrhage.[Ref]

Hematologic

Very common (10% or more): Lymphopenia (63%), thrombocytopenia (54%), anemia (44%), neutropenia (33%)[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (42%), nausea (17%), decreased appetite (16%), constipation (15%), stomatitis (12%)[Ref]

Dermatologic

Very common (10% or more): Rash (41%), dry skin (31%), nail toxicity (25%), pruritus (14%)[Ref]

-Rash cases included various types of rash (generalized, erythematous, macular, maculo-papular, papular, pustular), erythema, folliculitis, acne, dermatitis, and acneform dermatitis.
-Dry skin included eczema, skin fissures, and xerosis.
-Nail toxicity included nail and nail bed disorders, nail bed inflammation, nail bed tenderness, nail discoloration, nail dystrophy, nail infection, nail ridging, onychoclasis, onycholysis, onychomadesis, and paronychia.[Ref]

Metabolic

Very common (10% or more): Hyponatremia (26%), hypermagnesemia (20%)[Ref]

Ocular

Eye disorders included dry eye, blurred vision, keratitis, cataract, eye irritation, blepharitis, eye pain, increased lacrimation, and vitreous floaters.[Ref]

Very common (10% or more): Eye disorders (18%)
Uncommon (0.1% to 1%): Other ocular toxicities[Ref]

Respiratory

Very common (10% or more): Cough (14%)
Common (1% to 10%): ILD/pneumonitis, pneumonia[Ref]

Other

Venous thromboembolism included cases of deep vein thrombosis, jugular venous thrombosis, and pulmonary embolism.[Ref]

Very common (10% or more): Fatigue (14%)
Common (1% to 10%): Venous thromboembolism[Ref]

Musculoskeletal

Very common (10% or more): Back pain (13%)[Ref]

Nervous system

Very common (10% or more): Headache (10%)
Common (1% to 10%): CVA/cerebral hemorrhage[Ref]

Cardiovascular

Common (1% to 10%): Cardiomyopathy
Frequency not reported: QTc interval prolongation[Ref]

References

1. "Product Information. Tagrisso (osimertinib)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

It is possible that some side effects of osimertinib may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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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