Note: This document contains side effect information about osimertinib. Some dosage forms listed on this page may not apply to the brand name Tagrisso.
Summary
Common side effects of Tagrisso include: cough. Continue reading for a comprehensive list of adverse effects.
Applies to osimertinib: oral tablet.
Serious side effects of Tagrisso
Along with its needed effects, osimertinib (the active ingredient contained in Tagrisso) 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
- trouble 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
- Chest pain or tightness
- eye redness, irritation, or pain
- headache
- swollen or painful glands
- unusual bleeding or bruising
Incidence not known
- Blistering, peeling, loosening of the skin
- diarrhea
- itching
- joint or muscle pain
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- unusual tiredness or weakness
Other side effects of Tagrisso
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 the nails
- constipation
- decreased appetite
- nausea
- skin rash or dryness of the skin
- swelling or inflammation of the mouth
For Healthcare Professionals
Applies to osimertinib: oral tablet.
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%), vomiting (11%)[Ref]
Dermatologic
Very common (10% or more): Rash (e.g., generalized, erythematous, macular, maculopapular, papular, pustular), erythema, folliculitis, acne, dermatitis, acneiform dermatitis (58%), dry skin (e.g., eczema, skin fissures, xerosis) (36%), nail toxicity (e.g., nail and nail bed disorders, nail bed inflammation, nail bed tenderness, nail discoloration, nail dystrophy, nail infection, nail ridging, onychoclasis, onycholysis, onychomadesis, paronychia) (35%), pruritus (17%)
Postmarketing reports: Erythema Multiforme (EMM), Stevens-Johnson Syndrome (SJS), cutaneous vasculitis[Ref]
Metabolic
Very common (10% or more): Hyponatremia (26%), hypermagnesemia (20%)[Ref]
Ocular
Very common (10% or more): Eye disorders (e.g., dry eye, blurred vision, keratitis, cataract, eye irritation, blepharitis, eye pain, increased lacrimation, vitreous floaters) (18%)
Uncommon (0.1% to 1%): Other ocular toxicities[Ref]
Respiratory
Very common (10% or more): Cough (17%), dyspnea (13%)
Common (1% to 10%): ILD/pneumonitis, pneumonia[Ref]
Other
Very common (10% or more): Fatigue (22%)[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, venous thromboembolism (includes deep vein thrombosis, jugular venous thrombosis, and pulmonary embolism)
Frequency not reported: QTc interval prolongation[Ref]
