Tagrisso Side Effects

Generic name: osimertinib

Medically reviewed by Drugs.com. Last updated on Aug 12, 2024.

Note: This document provides detailed information about Tagrisso.

Applies to osimertinib: oral tablet Side Effects associated with osimertinib. Some dosage forms listed on this page may not apply specifically to the brand name Tagrisso.

Applies to osimertinib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects. Your dose may be reduced, or the medicine withheld or stopped, if certain side effects occur.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use effective birth control during treatment and for at least 6 weeks after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 4 months after the last dose. If you think you or your partner becomes pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a slow, fast, pounding, or uneven heartbeat.

This medicine may cause heart problems. Tell your doctor right away if you have fast, pounding, or uneven heartbeat, lightheadedness, trouble breathing, or swelling of your ankles or feet.

Check with your doctor right away if you have any changes to your eyes, such as eye pain or redness, or vision changes while you are using this medicine. Your doctor may want you to have your eyes checked by an eye doctor (ophthalmologist).

Serious skin reactions (eg, Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills ,cough, diarrhea, joint pain, red irritated eyes, red skin lesions, severe acne or skin rash, sore throat, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause cutaneous vasculitis (swelling of the blood vessels in the skin). Check with your doctor right away if you have blisters on the skin, purple spots or redness of the skin that does not fade when pressed on the lower arms, lower legs, or buttocks, or large hives on the trunk that do not go away within 24 hours and look bruised.

Check with your doctor right away if you have chest pain or tightness, chills, cough, fever, headache, sores, ulcers, or white spots in the mouth, swollen or painful glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These maybe symptoms of a blood problem (eg, aplastic anemia).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Tagrisso

Along with its needed effects, osimertinib (the active ingredient contained in Tagrisso) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking osimertinib:

Other side effects of Tagrisso

Some side effects of osimertinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to osimertinib: oral tablet.

Hematologic adverse events

• Very common (10% or more): Lymphopenia (63%), thrombocytopenia (54%), anemia (44%), neutropenia (33%)^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (42%), nausea (17%), decreased appetite (16%), constipation (15%), stomatitis (12%), vomiting (11%)^[Ref]

Dermatologic

• Very common (10% or more): Rash (e.g., generalized, erythematous, macular, maculopapular, papular, pustular), erythema, folliculitis, acne, dermatitis, acneiform dermatitis (58%), dry skin (e.g., eczema, skin fissures, xerosis) (36%), nail toxicity (e.g., nail and nail bed disorders, nail bed inflammation, nail bed tenderness, nail discoloration, nail dystrophy, nail infection, nail ridging, onychoclasis, onycholysis, onychomadesis, paronychia) (35%), pruritus (17%)
• Postmarketing reports: Erythema Multiforme (EMM), Stevens-Johnson Syndrome (SJS), cutaneous vasculitis^[Ref]

Metabolic

• Very common (10% or more): Hyponatremia (26%), hypermagnesemia (20%)^[Ref]

Ocular

• Very common (10% or more): Eye disorders (e.g., dry eye, blurred vision, keratitis, cataract, eye irritation, blepharitis, eye pain, increased lacrimation, vitreous floaters) (18%)
• Uncommon (0.1% to 1%): Other ocular toxicities^[Ref]

Respiratory

• Very common (10% or more): Cough (17%), dyspnea (13%)
• Common (1% to 10%): ILD/pneumonitis, pneumonia^[Ref]

Other

• Very common (10% or more): Fatigue (22%)^[Ref]

Musculoskeletal

• Very common (10% or more): Back pain (13%)^[Ref]

Nervous system

• Very common (10% or more): Headache (10%)
• Common (1% to 10%): CVA/cerebral hemorrhage^[Ref]

Cardiovascular

• Common (1% to 10%): Cardiomyopathy, venous thromboembolism (includes deep vein thrombosis, jugular venous thrombosis, and pulmonary embolism)
• Frequency not reported: QTc interval prolongation^[Ref]

See also:

Frequently asked questions

• What is Tagrisso used for?

Further information

Tagrisso side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer