Osimertinib

Pronunciation: oh-sim-ER-ti-nib.

Generic name: osimertinib
Brand names: TAGRISSO
Drug class: Epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor
Form: Film-coated tablet
Route: Oral tablet
Legal status: Prescription-only specialist anticancer medicine

Supply Rules Vary

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: TAGRISSO (4) · Full directory

What osimertinib is and how it works

Osimertinib is a targeted anticancer medicine that inhibits particular altered EGFR proteins. It is used in selected adults with EGFR-mutated non-small-cell lung cancer (NSCLC), including certain settings after surgery, after chemoradiation, or for locally advanced or metastatic disease. (1) (2) (3)

Osimertinib is not suitable for every lung cancer. An oncology team must confirm the diagnosis, disease setting, and relevant EGFR mutation with an appropriate test. The exact treatment plan may involve osimertinib alone or, for a specific indication, with chemotherapy.

Mechanism of action: how osimertinib works

Osimertinib is an irreversible EGFR tyrosine-kinase inhibitor active against sensitising EGFR mutations and the T790M resistance mutation, with less activity against wild-type EGFR than against relevant mutant forms in preclinical systems. (1) (3)

What osimertinib is used for

After complete tumour removal

Osimertinib may be used as adjuvant treatment for adults with eligible EGFR-mutated NSCLC after complete tumour resection. Stage and mutation requirements are label-specific. (1) (3)

Locally advanced disease after chemoradiation

Some current labels include selected unresectable stage III EGFR-mutated NSCLC that has not progressed during or after platinum-based chemoradiation. (3)

Locally advanced or metastatic disease

Osimertinib may be used alone, or in a label-defined first-line setting with pemetrexed and platinum chemotherapy, for eligible EGFR-mutated NSCLC. It is also used in defined EGFR T790M-positive disease settings. (1) (2) (3)

Before taking osimertinib

Do not take / not appropriate for

Do not use osimertinib without specialist confirmation that the cancer and EGFR test result fit an approved treatment setting. (all products) (1) (3)
Do not take it if you have had a serious allergic reaction to osimertinib or the product ingredients. (product-label dependent) (3)

Tell your clinician about

Any current or previous lung inflammation, breathing problem, or radiation treatment involving the lungs.
Heart failure, an abnormal heart rhythm, a long QT interval, fainting, or low potassium, magnesium, or calcium.
Eye pain, vision changes, severe dry eyes, or previous corneal disease.
Every prescription medicine, non-prescription medicine, vitamin, supplement, and herbal product, especially St John's wort.
Pregnancy, plans for pregnancy, breastfeeding, or fertility concerns.

(1) (2) (3)

How to take osimertinib

Take osimertinib exactly as directed by the oncology team, at about the same time each day.
Tablets may be taken with or without food.
Do not stop, reduce, or restart treatment without oncology advice.
If swallowing is difficult, use only the label-supported plain-water dispersion method supplied by the oncology pharmacist; do not crush, heat, or use another liquid.

(2) (3)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)

Missed dose

Follow the exact product leaflet and oncology instructions. Do not take two doses together to make up for a missed dose; contact the oncology team if you are unsure.

Overdose

If more osimertinib than prescribed may have been taken, contact the oncology service, poison-information service, or emergency care immediately. Bring the medicine packaging and do not wait for symptoms. (3)

Side effects

Side effects differ when osimertinib is used alone versus with chemotherapy. Report new symptoms early because the oncology team may need tests, supportive treatment, a temporary interruption, or a treatment change.

Diarrhoea, rash, dry skin, mouth soreness, or nail changes

What to notice: Loose stools, skin inflammation, cracking, mouth ulcers, or painful/inflamed skin around nails.

What to do: Tell the oncology team promptly, especially if symptoms are severe, persistent, affect drinking, or show signs of infection. (1) (2)

Changes in blood counts

What to notice: Fever, infection symptoms, unusual bruising or bleeding, or marked tiredness.

What to do: Contact the oncology team promptly; urgent assessment is needed for fever or significant bleeding. (1)

Eye symptoms

What to notice: Eye pain, redness, light sensitivity, excessive tearing, or blurred or changed vision.

What to do: Contact the oncology team promptly for eye assessment. (1) (2)

Muscle injury symptoms

What to notice: New unexplained muscle pain, tenderness, weakness, or dark urine.

What to do: Contact the oncology team urgently; recent Australian safety information includes myositis and rhabdomyolysis-related events. (5)

Serious warnings

Lung inflammation (interstitial lung disease or pneumonitis) — emergency

Symptoms: New or worsening shortness of breath, cough, or fever.

Action: Seek emergency assessment for severe breathing difficulty and contact the oncology team urgently. Follow the emergency plan you were given; the oncology team will advise whether any treatment change is needed. (1) (3) (5)

Heart rhythm or heart-pumping problem — urgent

Symptoms: Fainting, a fast or irregular heartbeat, chest discomfort, new breathlessness, swelling, or rapid unexplained weight gain.

Action: Seek urgent medical assessment and notify the oncology team. (1) (2)

Severe skin or mucosal reaction — emergency

Symptoms: Blistering or peeling rash, painful skin, mouth or eye sores, fever, or widespread skin tenderness.

Action: Seek emergency assessment immediately and contact the oncology team urgently. Follow the emergency plan provided by your team; they will decide whether treatment must be withheld or changed. (1) (5)

Aplastic anaemia or severe blood-cell reduction — urgent

Symptoms: Persistent fever or infections, unusual bruising or bleeding, pallor, or profound fatigue.

Action: Contact the oncology team urgently for assessment and blood counts. (1)

Interactions

Medicine or test	Effect	Action
Strong CYP3A inducers, including rifampicin, carbamazepine, phenytoin, and St John's wort	Can substantially reduce osimertinib exposure and may reduce treatment effectiveness.	The oncology pharmacist must review alternatives; do not start or stop an interacting medicine yourself. (1) (3)
Medicines that prolong the QT interval or disturb electrolytes	May increase heart-rhythm risk in a susceptible patient.	The oncology team should review the complete medicine list and decide whether ECG and electrolyte monitoring are needed. (1) (3)
Sensitive BCRP or P-gp substrate medicines	Osimertinib may increase exposure to some transported medicines; clinical importance depends on the co-medication.	An oncology pharmacist should check narrow-therapeutic-index or toxicity-sensitive medicines and monitoring requirements. (1) (3)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy and contraception

Osimertinib can harm an unborn baby. People who could become pregnant and partners who could father a pregnancy need product-label-specific contraception advice during treatment and for the required period after the final dose. (1) (2)

Breastfeeding

Breastfeeding is not recommended during treatment and for the product-label-defined period after the final dose. Confirm the current local label with the oncology team. (1) (2)

Liver, kidney, cardiac, or lung disease

Organ function and prior lung or heart disease can change risk and monitoring. The oncology team must use the exact local product information rather than a general web-page rule. (1) (3)

Monitoring

Before starting

Confirm the NSCLC setting and eligible EGFR mutation with an appropriate validated test.
Review all medicines and supplements, pregnancy risk, lung history, cardiac history, and electrolyte-risk factors.
Obtain complete blood count with differential; assess ECG, electrolytes, and cardiac function when label-defined risk factors or combination treatment make this appropriate.

During treatment

Assess promptly for new respiratory, cardiac, eye, skin, muscle, infection, or bleeding symptoms.
Repeat blood counts and other oncology-protocol monitoring at the responsible team's intervals.
Monitor ECG/electrolytes and cardiac function in patients meeting label-defined risk criteria or developing relevant symptoms.
Assess response, toxicity, adherence, and whether interruption, reduction, discontinuation, or supportive treatment is needed.

(1) (3) (5)

Storage

Keep the tablets in their original packaging, out of sight and reach of children, and follow the temperature and disposal instructions on the exact local pack and leaflet.

Professional information

Clinician-facing context only. Use the current local product label, tumour-stage and molecular-testing pathway, oncology protocol, and interaction resources.

All regions

Indication: Any osimertinib treatment

Dose summary: No universal regimen or dose-modification algorithm is displayed here. Confirm monotherapy versus combination therapy, indication, mutation, treatment duration, toxicity management, and local label before prescribing.

Renal context: Use the current local label and individual clinical context for renal or hepatic impairment and for patients with cardiac or pulmonary risk. (1) (3)

Mechanism of action

Hepatic guidance

Avoid simplifying impairment guidance into a patient dose rule; use the exact label, comorbidities, concomitant medicines, and toxicity findings.

Overdose note

There is no patient-managed overdose protocol. Provide urgent poison-centre and oncology assessment with supportive management. (1) (3)

Frequently asked questions

Is osimertinib used for every type of lung cancer?

No. It is used for particular EGFR-mutated non-small-cell lung cancer settings. An oncology team must confirm the diagnosis, stage or disease setting, and mutation-test result. (1) (3)

What should I do about new breathlessness or cough while taking osimertinib?

Contact the oncology team urgently because lung inflammation can be serious. Seek emergency care for severe breathing difficulty. (1) (2)

Can I take herbal products with osimertinib?

Do not start an herbal product without oncology-pharmacist review. St John's wort can reduce osimertinib exposure and should not be combined under current product information. (3)

What is the mechanism of action of osimertinib?

What is the generic name of Osimertinib?

The generic name is osimertinib. It is sold under brand names including TAGRISSO. (1) (2) (3)

What class of drug is osimertinib?

Osimertinib is classed as: Epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor. (1) (2) (3)

References

TAGRISSO (osimertinib) tablets — prescribing informationU.S. Food and Drug Administration · United States · dated 2024 · accessed 2026-07-22 · source 1
Osimertinib: MedlinePlus Drug InformationMedlinePlus, U.S. National Library of Medicine · United States · accessed 2026-07-22 · source 2
TAGRISSO 40 mg film-coated tablets — Summary of Product Characteristicselectronic Medicines Compendium (UK) · United Kingdom · dated 2025-12 · accessed 2026-07-22 · source 3
TAGRISSO osimertinib 40 mg tablet — ARTG 255493Therapeutic Goods Administration · Australia · accessed 2026-07-22 · source 4
Product Information safety updates — May 2026Therapeutic Goods Administration · Australia · dated 2026-05 · accessed 2026-07-22 · source 5

Brand names by country

Single-ingredient osimertinib names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

TAGRISSO80 mg, 40 mg · astrazeneca pharmaceuticals lp

United Kingdom

TAGRISSO (3)current licensed product · 40 mg, 80 mg · AstraZeneca UK Limited

Canada

TAGRISSO

Australia

TAGRISSO (4)current register product example · 40 mg · AstraZeneca Pty Ltd

View brands in additional countries.