Osimertinib can cause adverse reactions ranging from mild or manageable effects to potentially serious complications. The pattern varies according to treatment setting and whether osimertinib is used alone or with chemotherapy.
Common adverse reactions
Commonly reported reactions include:
- Diarrhea
- Rash
- Dry skin
- Nail toxicity or paronychia
- Stomatitis
- Reduced appetite
- Fatigue
- Cough
- Musculoskeletal pain
The EMA identifies diarrhea, rash, paronychia, dry skin and stomatitis among the common effects associated with Tagrisso monotherapy.
Important serious reactions
| Adverse reaction | Why it matters |
|---|---|
| Interstitial lung disease/pneumonitis | Can cause serious or fatal respiratory toxicity |
| QTc prolongation | Can increase arrhythmia risk |
| Cardiomyopathy | Can reduce cardiac function |
| Keratitis | May affect the cornea |
| Aplastic anemia | Rare but potentially life-threatening bone-marrow failure |
| Severe cutaneous reactions | SJS/TEN and other severe reactions require urgent management |
| Embryo-fetal toxicity | Can harm a developing fetus |
When urgent assessment may be needed
New or worsening shortness of breath, cough or fever can indicate lung toxicity. Chest symptoms, fainting, palpitations, severe weakness, significant visual symptoms, severe skin reactions or unusual bleeding also warrant prompt medical assessment.
Monitoring
Monitoring depends on treatment setting and patient risk. Cardiac assessment may be required, particularly when cardiac risk factors exist or when osimertinib is combined with chemotherapy.