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What are the side effects of tagrisso?

See the DrugPatentWatch profile for tagrisso

Common Side Effects of Tagrisso

Tagrisso (osimertinib), used to treat non-small cell lung cancer with EGFR mutations, causes side effects in most patients. Over 90% experience diarrhea, rash, dry skin, nail changes, mouth sores, fatigue, decreased appetite, nausea, cough, and low platelet counts.[1][2]

Patients often report skin issues like rash (affecting 58%), dry skin (36%), and nail pain or inflammation (35%). Gastrointestinal problems, including diarrhea (41%) and nausea (20%), are frequent early on.[1]

Serious Side Effects and Risks

Serious effects occur in about 20-30% of users and require monitoring:
- Interstitial lung disease (ILD)/pneumonitis: Affects 4%, can be fatal; symptoms include shortness of breath, cough, fever. Risk highest in first months.[1][2]
- Heart issues: QT interval prolongation (7-11%) raises arrhythmia risk; cardiomyopathy in 1-2%.[1]
- Eye problems: Keratitis (dry eyes, pain, blurred vision) in 4%; cataracts in some.[1]
- Embryo-fetal toxicity: Causes birth defects; contraindicated in pregnancy.[2]

Other risks include low white blood cells (leading to infections), electrolyte imbalances, and muscle pain.[1]

How Side Effects Compare by Dosage and Duration

At 80 mg daily (standard dose), side effects peak in cycles 1-2 then stabilize. Long-term use (over 6 months) sees persistent skin/nail issues but declining GI effects. Higher doses (160 mg) in trials increased severity, like more grade 3+ rashes.[1][3]

Managing Side Effects Patients Ask About

Doctors recommend moisturizers and steroids for skin reactions, antidiarrheals for GI issues, and eye drops for dryness. Dose interruptions or reductions handle severe cases; discontinuation rare (7%). Regular EKGs and lung imaging catch heart/lung risks early.[2][3]

Differences from Chemotherapy Side Effects

Unlike chemo's hair loss and severe nausea, Tagrisso spares hair but hits skin, nails, and lungs harder due to EGFR targeting. Fatigue is milder than chemo.[1]

[1]: Tagrisso Prescribing Information (AstraZeneca, FDA-approved label)
[2]: Drugs.com - Tagrisso Side Effects
[3]: FLAURA Trial Data (NEJM)



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