Tagrisso (osimertinib) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat certain types of non-small cell lung cancer (NSCLC) in adults.

NSCLC can have a type of mutation (abnormal change) in a gene called epidermal growth factor receptor (EGFR). Your doctor will have you take a blood test to check if your cancer cells have this mutation. If so, the cancer is called EFGR-positive (EGFR+) NSCLC.

Tagrisso is usually prescribed as a long-term treatment. It’s approved for use in adults who have EGFR+ NSCLC:

  • to help prevent NSCLC from recurring (coming back) after surgery to remove the tumor
  • as a first treatment when NSCLC becomes metastatic*
  • to treat metastatic NSCLC that didn’t improve after treatment with another EGFR tyrosine kinase inhibitor drug

Here are some fast facts on Tagrisso:

  • Active ingredient: osimertinib
  • Drug class: a type of targeted therapy called an EGFR tyrosine kinase inhibitor
  • Drug form: oral tablet

Like other drugs, Tagrisso can cause side effects. Read on to learn about potential common, mild, and serious side effects. Your doctor or pharmacist can provide more information about Tagrisso, including more information about how it’s used.

* Metastatic means that the cancer has spread from your lungs to other areas of your body.

Tagrisso can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are some of the more common side effects reported by people who took Tagrisso in clinical trials:

* Having a low red blood cell count is called anemia, which is discussed in detail in “Side effect specifics” below.
† For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur while taking Tagrisso. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Tagrisso’s patient information.

Mild side effects that have been reported with Tagrisso include:

These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Tagrisso and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Less commonly, Tagrisso may cause serious side effects in some people. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Tagrisso’s patient information.

If you develop serious side effects while taking Tagrisso, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

  • Serious lung problems, such as pneumonitis (inflammation of air sacs in the lungs) or interstitial lung disease (inflammation in lung tissue that leads to scar tissue). Symptoms can include:
    • trouble breathing
    • cough
    • fever
  • Vasculitis (inflammation of your blood vessels). Symptoms can include:
    • bruises or discolored spots that don’t fade in color when you press on them and don’t go away within 24 hours
    • hives (a raised, red rash) on your torso
  • Ocular (eye) side effects.*
  • Cardiac (heart) problems.*
  • Anemia (low levels of red blood cells).*
  • Low levels of white blood cells.
  • Low platelet levels.
  • Serious skin problems.*
  • Allergic reaction.*†

* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after taking Tagrisso. But this side effect wasn’t reported in clinical studies.

Learn more about some of the side effects that Tagrisso may cause.

Ocular (eye) side effects

Tagrisso may cause an ocular (eye) problem called keratitis. Keratitis is inflammation of the cornea (the clear outer layer at the front of your eye). This side effect was rare in clinical studies.

If keratitis isn’t treated, the inflammation could lead to corneal ulcers or scars.

Symptoms of keratitis may include:

  • eye pain or inflammation (swelling)
  • watery eyes
  • sensitivity to light
  • blurred vision
  • eye redness

Eyelid itching was also reported as a side effect in studies of Tagrisso. But it isn’t known how often this side effect occurred.

What you can do

If you notice any vision changes or eye discomfort while taking Tagrisso, call your doctor immediately. They’ll likely send you to an ophthalmologist (eye doctor) right away.

If you develop eye problems from Tagrisso, your doctor may have you pause or stop treatment.

Rash or other skin problems

Mild or serious skin problems can be side effects of Tagrisso.

More common but mild skin-related side effects may include:

Serious skin-related side effects are less common, but have been reported. Reports have included symptoms of Stevens-Johnson syndrome (SJS) and erythema multiforme major (EMM), such as:

  • skin blistering
  • skin peeling
  • “target-shaped” or ring-shaped skin lesions

What you can do

You might be able to manage mild skin side effects at home. For example, the following may help with dry skin:

  • increasing your daily fluid intake
  • moisturizing your skin with an emollient cream or lotion after showering
  • avoiding skin care products that contain drying ingredients such as alcohol or astringents

Over-the-counter medicated skin products may also help with other mild side effects of Tagrisso. Examples include:

If these suggestions aren’t helping or if you have skin side effects that bother you, talk with your doctor or pharmacist. They may recommend other treatments for your skin. Or they may recommend seeing a dermatologist (skin specialist).

If you develop skin problems that seem serious, you should seek immediate medical care. These could be signs of SJS or EMM, which can be life threatening.

Cardiac (heart) side effects

Serious cardiac (heart) problems can occur with Tagrisso. In clinical trials, these included heart rhythm problems and congestive heart failure (CHF), which led to death in rare cases.

CHF is a serious condition in which your heart doesn’t pump enough blood throughout your body. Symptoms may include:

  • trouble breathing
  • fluid buildup in your lower legs
  • fatigue (lack of energy)
  • dizziness

Long QT syndrome is one possible heart rhythm problem that may occur with Tagrisso. Symptoms of this condition may include dizziness and heart palpitations (feeling like your heart isn’t beating as it usually does).

What you can do

Before starting Tagrisso, be sure to tell your doctor about any heart problems you have (or have had in the past). They’ll help determine whether it’s safe for you to take Tagrisso.

If you notice any symptoms of heart-related side effects, tell your doctor right away. If they determine that you have a new or worsened heart problem, they may have you stop taking Tagrisso.

Nausea

Nausea is a more common side effect of Tagrisso. If nausea leads to vomiting, this may reduce your appetite.

In clinical studies, nausea was more severe in people who took Tagrisso with certain chemotherapy drugs. These drugs included Alimta (pemetrexed), or cisplatin and carboplatin.

What you can do

Your doctor will likely prescribe an antinausea medication to help treat and prevent future nausea with Tagrisso. A few examples of antinausea drugs include Zofran (ondansetron), Kytril (granisetron), Emend (aprepitant), and Compazine (prochlorperazine).

To ease nausea, it may also help to try the following:

  • Eat small, frequent snacks instead of three large meals a day.
  • Consider natural antinausea remedies such as ginger or pressure-point wristbands.
  • Try taking slow, deep breaths when you feel nauseous. Increasing airflow around you by opening a window or using a fan might also help.

If you have severe nausea, talk with your doctor. They may recommend other ways to relieve this side effect.

Anemia

Anemia occurs when your red blood cell levels become low. Your body needs red blood cells because they carry oxygen throughout your body.

The most common symptom of anemia is fatigue (lack of energy). Other symptoms can include:

What you can do

During treatment with Tagrisso, your doctor will monitor you for anemia using a blood test called a complete blood count. But if you develop anemia symptoms, you should let your doctor know.

There are several types of anemia treatments available. If you develop anemia from Tagrisso, your doctor will recommend which treatment is best for your condition.

Nail problems

Nail changes were commonly reported in clinical studies. These included:

  • nail pain
  • swelling
  • brittleness
  • partial or complete separation of the nail from the nailbed

Other reports included nail ridges, discoloration, and nail infection.

Less commonly, some people had their Tagrisso treatment temporarily paused or had their dosage reduced due to these side effects.

What you can do

If you develop nail problems after starting Tagrisso, talk with your doctor. They may recommend ways to treat this side effect, especially if you have infected nails. It’s important to talk with your doctor before making any changes to your dosage of Tagrisso.

Allergic reaction

As with most drugs, Tagrisso can cause an allergic reaction in some people. But this side effect wasn’t reported in clinical studies.

Symptoms can be mild or serious and can include:

  • rash
  • itching
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin, typically in your lips, eyelids, feet, or hands
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Tagrisso. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Tagrisso may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Are there any long-term side effects of Tagrisso?

Yes, it’s possible that Tagrisso could cause long-term side effects.

The more common side effects of Tagrisso, such as diarrhea and dry skin, are short term in most people. If they don’t go away, these side effects can usually be easily managed with over-the-counter remedies.

Another possible side effect of Tagrisso is keratitis (inflammation of the eye). With treatment from your eye doctor right away, this side effect typically doesn’t cause long-term effects.

But less commonly, Tagrisso can cause serious cardiac (heart) problems, such as heart failure. If you develop heart failure, it’s likely to require long-term treatment.

For more information about long-term side effects of Tagrisso, talk with your doctor or pharmacist.

Do the side effects of Tagrisso vary based on the drug’s strength (40 mg or 80 mg)?

This is possible. The recommended dosage of Tagrisso is 80 milligrams (mg) once per day. This recommendation is based on clinical studies showing that this dosage is an effective treatment for non-small cell lung cancer in adults.

It’s possible that the side effects of Tagrisso may be less severe with a lower strength. The lower strength (40 mg) is usually only prescribed if you’re restarting Tagrisso after you’ve stopped it due to certain side effects. One example is after a person develops a slight change in their heart rhythm.

You should not stop taking Tagrisso or change your dosage without first talking with your doctor.

Your doctor will work with you to help manage any side effects you experience from Tagrisso treatment.

Be sure to talk with your doctor about your health history before you take Tagrisso. This drug may not be the right treatment for your condition if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:

Risk factors of heart problems. Tagrisso can cause side effects that affect the heart, including long QT syndrome and heart failure. You may have a higher risk for these side effects if you:

  • have heart problems
  • take drugs that affect your QT interval (part of your heart rhythm)
  • have high or low levels of electrolytes, such as calcium, potassium, magnesium, or sodium

Be sure to talk with your doctor about your medical conditions and any medications you’re taking. They’ll discuss the risks and benefits of Tagrisso treatment with you.

Allergic reaction. You shouldn’t take Tagrisso if you’ve ever had an allergic reaction to Tagrisso or any of its ingredients. Talk with your doctor about which other treatments are better choices for your condition.

Alcohol and Tagrisso

Alcohol isn’t known to interact with Tagrisso.

But alcohol may cause some of the same common side effects as Tagrisso. These include nausea, abdominal (belly) pain, and dizziness.

If you drink alcohol, talk with your doctor about how much alcohol (if any) is safe for you to drink during treatment.

Pregnancy and breastfeeding while taking Tagrisso

Tagrisso shouldn’t be taken during pregnancy. And if you’re able to have children, you should use birth control while you’re taking Tagrisso and for some time after treatment:*

  • females† should continue using birth control for 6 weeks after their last dose
  • males† should continue using birth control for 4 months after their last dose

You should not breastfeed while taking Tagrisso or for 2 weeks after your last dose. In animal studies, giving Tagrisso to lactating animals caused an increased risk for death and growth problems in their offspring.

If you have questions about birth control, family planning, or feeding options with Tagrisso, talk with your doctor.

* In animal studies, Tagrisso caused fetal harm and pregnancy loss. This finding was observed when pregnant female animals were given Tagrisso. Pregnancy loss also occurred when Tagrisso was given to male animals before they mated with untreated female animals. But it’s important to note that animal studies don’t always reflect what will happen in humans.
† Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Like all prescription drugs, taking Tagrisso may cause mild or serious side effects. Not everyone who takes Tagrisso develops side effects, but some side effects are more common than others.

If you’d like to learn more about Tagrisso, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, the Medical News Today cancer hub may be helpful for more information about your condition. This list of lung cancer articles can also provide more information.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.