Osimertinib
Osimertinib is a once-daily targeted cancer pill for non-small cell lung cancer (NSCLC) with certain EGFR gene changes, used after surgery, after chemoradiation for stage III disease, and for metastatic or previously treated disease.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Osimertinib (Tagrisso), on the market since about 2015, is a once-daily targeted tablet for non-small cell lung cancer with certain test-confirmed EGFR gene changes; it blocks the EGFR growth signal, favoring mutated forms over normal EGFR, and is now the usual first choice for this cancer, from after surgery to advanced disease. Most people manage it well, often better than older EGFR drugs, with diarrhea, rash, dry skin and nail changes the usual complaints. The one thing to watch for is new or worsening cough, shortness of breath or fever, which can signal lung inflammation (pneumonitis) that can be severe or even fatal, so call your care team right away.
Clinical pearls
- Expect ECGs (heart rhythm tracings), heart function checks and blood counts before and during treatment; report fainting or a racing heartbeat.
- Strong CYP3A inducers, which speed its breakdown (St. John's wort is one), can weaken it, so check any new medicine first.
- Use effective contraception during treatment and for 6 weeks after (women) or 4 months after (men with partners who could conceive).
- Report eye pain, redness or light sensitivity, plus any blistering or peeling skin, promptly, since both can become serious.
Patient information guide A plain-language walkthrough of Osimertinib, written from its FDA label.
What Osimertinib is used for
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Osimertinib treats non-small cell lung cancer (NSCLC) with specific EGFR changes in adults. Uses for Tagrisso tablets include:
- Adjuvant (after surgery) treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations
- Stage III unresectable NSCLC with these mutations that has not progressed after platinum-based chemoradiation
- First-line treatment of metastatic NSCLC with these mutations
- First-line treatment of locally advanced or metastatic NSCLC with these mutations, together with pemetrexed and platinum-based chemotherapy
- Metastatic EGFR T790M-positive NSCLC that has progressed on or after EGFR TKI therapy
How Osimertinib works
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Osimertinib is a kinase inhibitor that blocks EGFR, a protein that can fuel cancer growth. It binds irreversibly to certain mutated forms of EGFR (T790M, L858R and exon 19 deletions) at lower concentrations than normal EGFR.
In animal studies, it also reached the brain.
Osimertinib dosage
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Tagrisso is a tablet taken by mouth once daily, with or without food. Treatment length depends on the use, such as up to 3 years after surgery or until the disease progresses or side effects become unacceptable.
- If you miss a dose, do not make it up; take the next one on schedule.
- If swallowing is hard, the tablet can be dispersed in non-carbonated water, but it should not be crushed or heated.
- Follow your prescriber and label for your exact dose.
Dosing details from the FDA-approved label
From the Osimertinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adjuvant treatment of EGFR mutation-positive NSCLC
- 80 mg tablet orally once daily with or without food
- For a total of 3 years or until disease recurrence or unacceptable toxicity
- Locally advanced, unresectable (stage III) EGFR mutation-positive NSCLC
- Following platinum-based chemoradiation therapy, 80 mg tablet orally once daily with or without food
- Until disease progression or unacceptable toxicity
- First-line treatment of EGFR mutation-positive metastatic NSCLC
- 80 mg tablet orally once daily with or without food
- Until disease progression or unacceptable toxicity
- First-line treatment of EGFR mutation-positive locally advanced or metastatic NSCLC
- 80 mg tablet orally once daily with or without food in combination with pemetrexed and platinum-based chemotherapy
- Until disease progression or unacceptable toxicity due to TAGRISSO
- Previously treated EGFR T790M mutation-positive metastatic NSCLC
- 80 mg tablet orally once daily with or without food
- Until disease progression or unacceptable toxicity
- Patients taking a strong CYP3A4 inducer when concurrent use is unavoidable
- Increase TAGRISSO dosage to 160 mg daily
- Resume 80 mg 3 weeks after discontinuation of the strong CYP3A4 inducer
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Adjuvant treatment of early-stage NSCLC: 80 mg orally once daily, with or without food, until disease recurrence, or unacceptable toxicity, or for up to 3 years. ( 2.3 ) Locally advanced, unresectable (stage III) NSCLC: Following platinum-based chemoradiation therapy, 80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity. ( 2.3 ) Metastatic NSCLC: 80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity. ( 2.3 ) Locally advanced or metastatic NSCLC: 80 mg orally once daily administered in combination with pemetrexed and platinum-based chemotherapy, with or without food, until disease progression or unacceptable toxicity due to TAGRISSO. ( 2.3 ) 2.1 Recommended Evaluation and Testing Before Initiating TAGRISSO TAGRISSO Monotherapy • Before initiating TAGRISSO monotherapy in patients with cardiac risk factors, conduct cardiac monitoring, including assessment of left ventricular ejection fraction (LVEF) [see Warnings and Precautions (5.3) ] . • Before initiating TAGRISSO, perform complete blood count with differential [see Warnings and Precautions (5.7) ] . TAGRISSO in Combination with Pemetrexed and Platinum-based Chemotherapy • Before initiating TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of left ventricular ejection fraction (LVEF) [see Warnings and Precautions (5.3) ] . • Before initiating TAGRISSO, perform complete blood count with differential [see Warnings and Precautions (5.7) ] . 2.2 Patient Selection Table 1 below presents the patient selection criteria for treatment with TAGRISSO. Table 1: Patient Selection Select patients for treatment with TAGRISSO based on the presence of a mutation as detected by an FDA-approved test.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Osimertinib side effects
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Common side effects of Tagrisso include:
Common side effects
- Diarrhea
- Rash
- Dry skin
- Nail problems
- Mouth sores (stomatitis)
- Muscle and joint pain
- Tiredness
- Low blood cell counts found on blood tests
- Low white blood cell, platelet and red blood cell counts on lab tests
When to get medical help
- Call your doctor right away for new or worsening cough, shortness of breath or fever, which can signal lung inflammation (ILD/pneumonitis).
- Get help for chest symptoms, swelling, fainting or a racing or irregular heartbeat, which may point to heart problems.
- Call your doctor for eye pain, redness, light sensitivity, blurred vision or watery eyes.
- Seek urgent care for severe blistering or peeling skin, or skin sores or spots that look like vasculitis.
- Report new or ongoing fever, unusual bruising or bleeding, or pale skin, which can be signs of aplastic anemia.
Seek care quickly for breathing changes, heart symptoms, eye problems, severe skin reactions or signs of bone marrow failure.
Osimertinib warnings and precautions
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- Lung inflammation (ILD/pneumonitis) can be severe or fatal. Tagrisso is stopped if it is confirmed (with some exceptions after chemoradiation).
- QTc prolongation can affect heart rhythm; ECGs and electrolytes may be monitored.
- Cardiomyopathy occurred in 3.8% of patients; heart function is monitored.
- Keratitis, severe skin reactions, cutaneous vasculitis and aplastic anemia can occur.
- It can harm an unborn baby.
Osimertinib interactions
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Some medicines can change how Tagrisso works or how other drugs behave.
- Strong CYP3A inducers: lower osimertinib levels and may reduce effectiveness.
- BCRP or P-gp substrate drugs: levels may rise, increasing the chance of side effects.
- QTc-prolonging drugs: may need ECG monitoring.
Interactions listed in the FDA-approved label
From the Osimertinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inducers: Co-administration decreased osimertinib exposure compared to TAGRISSO alone, which may lead to reduced efficacy. Avoid concomitant use. If concurrent use is unavoidable, increase TAGRISSO to 160 mg daily; resume 80 mg 3 weeks after the inducer is discontinued.
- Moderate and/or weak CYP3A inducers: No dose adjustments are required when TAGRISSO is used with moderate and/or weak CYP3A inducers.
- BCRP or P-gp substrates: Co-administration increased the exposure of the substrate, which may increase the risk of exposure-related toxicity. Monitor for adverse reactions of the BCRP or P-gp substrate, unless otherwise instructed in its approved labeling.
- Drugs that prolong the QTc interval: The effect of co-administering drugs known to prolong the QTc interval with TAGRISSO is unknown. When feasible, avoid concomitant use of drugs known to prolong the QTc interval with known risk of Torsades de pointes; if not feasible, conduct periodic ECG monitoring.
Read the label’s full interactions text
7 DRUG INTERACTIONS Strong CYP3A Inducers : Avoid concomitant use. If not possible, increase TAGRISSO to 160 mg daily in patients receiving a strong CYP3A4 inducer. ( 2.5 , 7.1 ) 7.1 Effect of Other Drugs on Osimertinib Strong CYP3A Inducers Co-administering TAGRISSO with a strong CYP3A4 inducer decreased the exposure of osimertinib compared to administering TAGRISSO alone [see Clinical Pharmacology (12.3) ] . Decreased osimertinib exposure may lead to reduced efficacy. Avoid co-administering TAGRISSO with strong CYP3A inducers. Increase the TAGRISSO dosage when co-administering with a strong CYP3A4 inducer if concurrent use is unavoidable [see Dosage and Administration (2.5) ] . No dose adjustments are required when TAGRISSO is used with moderate and/or weak CYP3A inducers. 7.2 Effect of Osimertinib on Other Drugs Co-administering TAGRISSO with a breast cancer resistant protein (BCRP) or P-glycoprotein (P-gp) substrate increased the exposure of the substrate compared to administering it alone [see Clinical Pharmacology (12.3) ] . Increased BCRP or P-gp substrate exposure may increase the risk of exposure-related toxicity. Monitor for adverse reactions of the BCRP or P-gp substrate, unless otherwise instructed in its approved labeling, when co-administered with TAGRISSO. 7.3 Drugs That Prolong the QTc Interval The effect of co-administering medicinal products known to prolong the QTc interval with TAGRISSO is unknown. When feasible, avoid concomitant administration of drugs known to prolong the QTc interval with known risk of Torsades de pointes. If not feasible to avoid concomitant administration of such drugs, conduct periodic ECG monitoring [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.2) ].
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Osimertinib
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- There are no listed contraindications.
- Tell your doctor about heart, lung or electrolyte problems.
- Do not use while pregnant; use effective contraception during treatment and for 6 weeks (women) or 4 months (men) after.
- Do not breastfeed during treatment and for 2 weeks after.
- Not established in children.
- Older adults may have more serious side effects.
- No dose adjustment is recommended for mild to moderate kidney impairment or mild to moderate liver impairment. There is no recommended dose for end-stage kidney disease or severe liver impairment.
What Osimertinib does in the body
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Higher osimertinib exposure was linked to more rash, diarrhea and ILD. It can also lengthen the QTc interval, a heart rhythm measure. At the standard dose, the average increase was about 14 to 16 msec.
How your body processes Osimertinib
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After a dose, blood levels peak at a median of about 6 hours. Food does not meaningfully change absorption. Steady levels build up over about 15 days, and the half-life is about 48 hours. It is broken down mainly by CYP3A and eliminated mostly in feces (68%), with less in urine (14%).
How to store Osimertinib
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Store TAGRISSO bottles at 25°C (77°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Osimertinib
164 supplements and herbal products have documented interactions with Osimertinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 117
- Minor · 39
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Osimertinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Osimertinib — the kind of thing our pharmacy team would talk through with you at the counter.
What is osimertinib used for?
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How do I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Do other medicines affect it?
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Is it safe in pregnancy?
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Is Osimertinib available over the counter?
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When was Osimertinib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Osimertinib on HelloPharmacist
Osimertinib forms and strengths (how it comes)
Osimertinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Osimertinib inactive ingredients by manufacturer.
Tablet
How this form is used
- Tagrisso is used for EGFR mutation-positive non-small cell lung cancer in adults, including after surgery and for metastatic disease.
- Tagrisso can be used with pemetrexed and platinum-based chemotherapy for first-line locally advanced or metastatic disease.
- Tagrisso tablets are taken by mouth once daily, with or without food.
- Tagrisso tablets may be dispersed in non-carbonated water if you have trouble swallowing; do not crush or heat them.
- If you miss a Tagrisso dose, skip it and take the next dose as scheduled.
Osimertinib on the U.S. market: products, makers and brands
How Osimertinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 4 Osimertinib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2015. Brand names on the directory include Tagrisso; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Osimertinib is used (Medicaid data)
A general measure of how commonly Osimertinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Osimertinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Osimertinib prescribed? Of the 1,601 medications we measure, Osimertinib ranks #960 by Medicaid prescriptions — more than 40% of them.
Utilization by Osimertinib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
osimertinib 80 MG Oral Tablet Most dispensed
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1721581
osimertinib 40 MG Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1721565
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Osimertinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 10 listed Osimertinib NDCs with Medicaid activity.
Compare Osimertinib products
A representative set of FDA-listed product records for Osimertinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 40 mg | Oral | AstraZeneca Pharmaceuticals LP × 2 listings | NDA | View NDC → |
| 80 mg | Oral | AstraZeneca Pharmaceuticals LP × 2 listings | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Osimertinib NDCs →
Osimertinib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Osimertinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Osimertinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Osimertinib FDA approval history
How Osimertinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Osimertinib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Osimertinib recalls since July 2021.
✅No Osimertinib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1721560 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 1721564In current FDA listings
Look up RxCUI 1721560 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Osimertinib supply and shortage status
Whether Osimertinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Osimertinib brand names
Osimertinib is sold under one brand name in the FDA directory — Tagrisso. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Osimertinib: manufacturers and labelers
One company lists Osimertinib products with the FDA. By number of product records, the largest are AstraZeneca Pharmaceuticals LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Osimertinib drug class (RxNorm)
Osimertinib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Osimertinib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. AstraZeneca Pharmaceuticals LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →