Osimertinib: uses, dosing, side effects & brands
Osimertinib is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Tablet
- Sold as
- Tagrisso
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
Every osimertinib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Tagrisso.
Osimertinib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for osimertinib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of osimertinib during breastfeeding. Because osimertinib is 95% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 48 hours and it might accumulate in the infant. The drug also has 2 active metabolites that have not been studied in breastmilk. The manufacturer recommends that breastfeeding be discontinued during osimertinib therapy and for 2 weeks after the final dose.
National Institute of Child Health and Human Development, record revised December 21, 2002. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about osimertinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 578 reports naming osimertinib, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- myelosuppression252 reports
- hepatic function abnormal37 reports
- platelet count decreased31 reports
- malignant neoplasm progression28 reports
- interstitial lung disease24 reports
- decreased appetite23 reports
- nausea23 reports
- drug resistance22 reports
Read these as a signal, not a rate. A report does not mean osimertinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
Can you take osimertinib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run osimertinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does osimertinib come in?
Across the brands we track, osimertinib is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic osimertinib?
We do not currently list a generic-labelled osimertinib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Osimertinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/osimertinib
- MLA
- “Osimertinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/osimertinib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for osimertinib on DailyMed (NIH) ↗.