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Osimertinib Side Effects

For the Consumer

Applies to osimertinib: oral tablet

Along with its needed effects, osimertinib 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 osimertinib:

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
  • slurred speech
  • sudden loss of coordination
  • sudden, severe headache
  • sudden, severe weakness or numbness in the arm or leg
  • troubled breathing

Less Common

  • Blurred vision
  • chills
  • fever
  • 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

Rare

Some side effects of osimertinib 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

  • 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.

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.

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