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Osimertinib Side Effects: Common, Severe, and Long-Term Risks You Should Know

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Category: Generic Drugs
Published: 10, Apr 2025 Last Updated: 10, Apr 2025
Osimertinib Side Effects: Common, Severe, and Long-Term Risks You Should Know

Doctors often prescribe Osimertinib to treat lung cancer associated with specific EGFR (epidermal growth factor receptor) mutations. However, its effects extend beyond this targeted treatment. While some Osimertinib side effects are mild, temporary, and resolve on their own, others can be more severe or persistent.

Some issues may appear early, while others develop after consuming Osimertinib for a long time. Understanding these potential Osimertinib side effects can help in making informed decisions and managing health disorders effectively. 

What is Osimertinib?

Osimertinib is a medication used to treat certain types of lung cancer associated with EGFR (epidermal growth factor receptor) mutations. It is commonly sold under the brand name Tagrisso and works by preventing the protein production that causes cancer cells to grow and rapidly multiply. 

In short, it helps to slow down or even stop the growth of cancer cells, making it an effective treatment option. Osimertinib may treat other health conditions and it is essential to consult with your healthcare provider or pharmacist before consuming.

Why use Osimertinib?

Read the following section to understand why this medication is prescribed by the doctors: 

  • Doctors recommend taking Tagrisso (osimertinib) to treat certain types of lung cancer with epidermal growth factor receptor (EGFR) mutations. EGFR is a protein layer, seen on the surface of cells. It plays a vital role in cancer cell growth and multiplication.

  • When an EGFR mutation occurs, cancer cells grow and multiply rapidly. In this situation, doctors often recommend Tagrisso (osimertinib) either as a standalone treatment or in combination with other effective medications to specifically target EGFR-mutated non-small cell lung cancer (NSCLC).

  • Osimertinib can be used to treat advanced NSCLC that has spread to nearby tissues and is no longer surgically removable. It is best for people who have already undergone chemotherapy and radiation treatments.

How Does it Work?

Osimertinib or Tagrisso, targets EGFR (epidermal growth factor receptor) proteins found on the surface of cancer cells. These proteins play a crucial role in promoting the growth and multiplication of cancer cells. 

If you have cancer with EGFR mutations, you are considered EGFR positive, and this medication is designed to target and treat that specific mutation. Doctors will ask you to do some tests to check the presence of these receptors before prescribing this medicine.

Osimertinib can help limit the spread or stop the growth of cancer, especially in its advanced stages. In some cases, it may also be used to prevent cancer recurrence after surgery, offering an additional layer of protection against the return of the disease.

What Should You Tell Your Doctor Before Taking This Medicine?

Your healthcare provider needs to know if you have any of these medical conditions:

  • Heart disease

  • History of blood diseases, such as aplastic anaemia

  • High or low levels of magnesium, potassium, or sodium in your blood

  • Eye disease

  • Lung dysfunction

  • Irregular heartbeat or rhythm

  • Other medications or supplements that you are currently consuming

  • Pregnant or trying to get pregnant

  • Breast-feeding

Most Common Side Effects

Here is the list of Osimertinib side effects that are most common. Notify your doctor if you encounter any of these issues persistently:

  • Blood disorders 

  • Rash

  • Diarrhea

  • Nail changes such as swelling, pain, redness, breaking, and separation or loss from nail bed

  • Muscle or bone pain

  • Tiredness

  • Dry skin

  • Mouth sores

  • Anxiety

  • Chest pain

  • Dizziness or fainting

  • Sudden, severe headache

  • Breathing trouble

  • Weakness or numbness in the arm or leg

  • Slurred speech

  • Constipation

  • Itching

  • Dry or cracking skin

Less Common Osimertinib Side Effects

Although less common, the most serious side effects of Osimertinib are outlined below. Review this information to understand how to respond if they occur: 

  1. Severe Allergic ReactionsBy consuming Tagrisso, people may experience some serious allergic reactions. Stop consuming it and consult with your healthcare provider if you notice any of the following symptoms of a severe allergic reaction:

  • Joint pain

  • Breathing problems or wheezing

  • Uneven heartbeat

  • Swollen lymph nodes

  • Nausea or vomiting

  • Cramps in stomach

  • Swelling of the face, lips, mouth, tongue, or throat

  • Fever or general ill feeling

  • Itching, skin rash, or pale red bumps on the skin called hives

  • Trouble swallowing or throat tightness

  1. Lung Inflammation: Interstitial lung disease or inflammation in your lungs is another serious Osimertinib side effect. This can be life-threatening if it remains untreated for a long time. Do not hesitate to reach out to a healthcare provider if you face breathing issues, breath shortness, wheezing, or chest tightness. Prolonged cough and/or fever are additional symptoms of lung inflammation.

  1. Rhythmic Changes in Heart: Tagrisso may cause heart rhythm issues, leading to an irregular heartbeat and fainting problems. This may lead to cardiac arrest, causing the heart to stop beating suddenly. Opt for emergency help if you experience any of the following signs in your heart: 

  • Intense chest pain

  • Feeling dizzy, lightheaded, or fainting

  • Changes in your heart rate can include a fast or slow heartbeat, and you may sometimes experience a pounding or skipping sensation.

  1. Drastic Skin Reactions: While Osimertinib is an effective treatment for EGFR-positive lung cancer, it is important to be aware of severe Osimertinib side effects that can occur, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). These are serious skin reactions that can be life-threatening if left untreated: 

  • Painful skin

  • Red or purple skin that looks burned 

  • Red rashes or blisters on your skin, genitals, mouth and nose

  • Painful, watery eyes with redness

  1. Disorders in Blood: Some patients suffer from blood infections after consuming osimertinib for a period. These include thrombocytopenia or low platelet levels, leukopenia or low white blood cell levels, and aplastic anaemia. Do not take Tagrisso and reach out to a healthcare provider if you identify any of the following symptoms: 

  • Pale or yellowish skin

  • Bleeding or easy bruising

  • Frequent blood infection

  • Headache

  • Abnormal heartbeat

  • Feeling like you are about to pass out

  1. Critical Immune System Reactions: By taking Tagrisso, some patients may experience inflammation of the liver, blood vessels, or lymph vessels. This immune system reaction is also known as cutaneous vasculitis. 

Other than that, some individuals also experience urticarial vasculitis, leukocytoclastic vasculitis, and IgA vasculitis. Stop taking osimertinib then and consult with your doctor right away if you discover any of the following signs in your body: 

  • Purple spots, redness, 

  • Skin discolouration that does not fade after pressing it

  • Large hives on a significant part of your body (torso)

  • Severe level of rashes

  • Joint pain

  • Persistent Fever

  • Tiredness for a longer period

Rare Osimertinib Side Effects

There are some rare side effects observed in people consuming Osimertinib or Tagrisso:

  1. Eye Issues: Tagrisso can, in rare cases, cause eye problems such as ulcers. Make a doctor's appointment if you observe the following eye issues.

  • Eye pain

  • Watery eyes due to irritation

  • Swelling or redness in the eye

  • Blurry vision

  • Sensitivity to light

  1. Heart Failure: Tagrisso can increase the potential for heart failure. Reach out to your healthcare provider instantly if you notice the following symptoms of heart failure: 

  • Unusual or prolonged tiredness

  • Breath shortness or trouble breathing, especially when you lie down

  • Swelling in your feet, ankles, or legs

  • Fast weight gain

How to Store Osimertinib?

Store Osimertinib in a closed container at room temperature between 20°C and 25°C or 68°F and 77°F. Always, keep this medicine away from heat, moisture, and direct sunlight. Also, avoid freezing and store medications out of reach of children and pets. Dispose of any unused medication if it has expired.

Special Precautions to Take Before Taking Osimertinib

Before taking osimertinib, you need to follow these precautions: 

  • Tell your healthcare provider if you are allergic to osimertinib.

  • Inform your doctor about the prescribed and non-prescribed medications that you take. Also, tell the names of vitamins, nutritional supplements, and herbal products you are consuming. 

  • Tell your healthcare provider if you have or ever had the following symptoms: 

    • QT syndrome; an irregular heartbeat issue; high blood pressure; heart failure; sodium, potassium, calcium, or magnesium level imbalances in your blood; severe eye problems; lung dysfunctions, lung cancer; or kidney disease.

  • Inform your doctor if you are a mother of an infant. In this case, your doctor may advise against breastfeeding while taking osimertinib, and to avoid it for 2 weeks after the final dose.

After knowing this, your doctor may change the doses of your medications or ask you to monitor the side effects of Osimertinib.

Osimertinib Interactions with Other Medications

Here is a table of medicines that have a high chance of interacting with Osimertinib. Although this table does not include all possible drug interactions with Tagrisso, it can offer you an insight into potential risks: 

Medicine Class

Medicine Examples

Interaction Results with Osimertinib

Specific antipsychotics

  • clozapine (Clozaril)


  • aripiprazole (Abilify)

  •  quetiapine (Seroquel)

Can cause long QT syndrome, an abnormal heart rhythm, potentially leading to serious cardiac issues.

Particular anti-sickness drugs

  • ondansetron (Zofran)

  • dolasetron (Anzemet)

May lead to long QT syndrome, increasing the risk of abnormal heart rhythms.

certain HIV medications

  • efavirenz

  • rilpivirine (Edurant)

  • dolutegravir (Tivicay)

Can increase the risk of side effects from HIV drugs, including the development of long QT syndrome.

Some antibiotics

  • moxifloxacin (Avelox)

  • clarithromycin

  • azithromycin (Zithromax)

May lead to abnormal heart rhythm or exacerbate existing heart issues. 

Certain antidepressants

  • escitalopram (Lexapro)

  • citalopram (Celexa)

  • clomipramine (Anafranil)

Can cause long QT syndrome, leading to an abnormal heart rhythm and potential cardiac risks.

Antiarrhythmics

  • amiodarone (Pacerone)

  • sotalol (Betapace, Sorine)

  • disopyramide (Norpace)

Can cause or worsen long QT syndrome, which may lead to life-threatening arrhythmias.

Antituberculosis Medication

  • Rifampin 

  • Rifadin

  • Rimactane

Can reduce Osimertinib's effectiveness by increasing its metabolism, and lowering drug levels in the body.

Cholesterol Medications

  • Rosuvastatin 

May heighten the risk of rosuvastatin side effects, such as muscle problems or liver damage.

Anti-diarrheal Medications

  • Loperamide 

May increase the risk of side effects from loperamide, such as heart rhythm problems or constipation.

Specific seizure drugs

  • carbamazepine (Tegretol, others)

  • phenytoin (Dilantin)

  • phenobarbital

May reduce Osimertinib's effectiveness, making it less effective in treating cancer.

Bottom Line 

Osimertinib is a breakthrough invention when it comes to lung cancer treatment, but it comes with several risks. However, like all powerful medications, it comes with both mild and more serious potential side effects. 

While some Osimertinib side effects may be temporary and manageable, others—though rare—can be severe, affecting vital organs and leading to long-term health complications. Understanding these effects are crucial for safe treatment. 

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Frequently Asked Questions 

  1. What is one of the worst side effects of medication?

There are several serious side effects of Tagrisso, including severe allergic reactions, heart rhythm changes, cardiac arrest, critical eye issues, severe skin reactions, lung inflammation, and blood disorders.

  1. What foods should you avoid when consuming Osimertinib?

Grapefruit and grapefruit juice can interfere with Osimertinib, affecting its blood levels and potentially reducing its effectiveness or increasing side effects. It is important to avoid them during treatment.

  1. Do Tagrisso side effects go away?

Taking Tagrisso can cause several side effects, some more common than others. These side effects may last for a few days or weeks. However, there are also severe and rare risks that require consultation with a certified doctor.

  1. Where to buy Osimertinib medications?

When it comes to buying osimertinib medication, always choose trusted sources like Indogenmed. We offer premium-quality, doctor-approved medications delivered to your door. We aim to provide sustainable and cost-effective medicines for the most serious illnesses in the world.

  1. Are there any interactions between Tagrisso and vaccines?

Medical findings suggest no known interactions between osimertinib and vaccines. However, it is important to inform your doctor or pharmacist if you are due for or have recently received any vaccines.

  1. What if I miss a dose of osimertinib?

If you forget to take a dose, simply skip it. Take your next osimertinib pill at the scheduled time. Avoid taking an additional dose or two doses at the same time to compensate for the missed one.

  1. What is the recommended duration of osimertinib treatment?

Osimertinib (Tagrisso) is typically recommended for a duration of 3 years as an adjuvant treatment for completely resected stage IB-IIIA or stage IIIB (T3, N2) EGFR-mutated (exon 19 deletion, exon 21 L858R mutation) non-small cell lung cancer (NSCLC), according to NCCN Guidelines.

  1. What are the potential cardiac risks associated with osimertinib?

Although rare, osimertinib has been associated with cardiotoxicity, including conditions like cardiac failure, QT prolongation, and atrial fibrillation, particularly in patients with advanced NSCLC.

  1. How long can I take osimertinib?

The duration of osimertinib treatment is individualized based on how well the medication is working and the patient's ability to manage any side effects. Typically, you will continue treatment as long as it remains effective and the side effects are manageable, with your doctor regularly monitoring your progress.

Disclaimer: Always consult with a certified healthcare provider before consuming Osimertinib tablets to ensure safety and suitability for your health needs.

Reference:

https://www.mayoclinic.org/drugs-supplements/osimertinib-oral-route/description/drg-20165188

https://my.clevelandclinic.org/health/drugs/19333-osimertinib-tablets

https://www.webmd.com/drugs/2/drug-170434/tagrisso-oral/details

https://www.cancerresearchuk.org/about-cancer/treatment/drugs/osimertinib

https://www.medicalnewstoday.com/articles/drugs-tagrisso-interactions#tagrisso-and-other-medications 

Disclaimer

Indogenmed’s primary goal is to provide expert-reviewed, accurate, and reliable information to its users. However, the information provided here is not intended to replace the advice of a qualified healthcare professional. It is for informational purposes only and may not cover every aspect of specific health conditions, lab tests, medications, potential side effects, drug interactions, warnings, or alerts. We encourage you to consult your doctor for any medical concerns or questions. Our aim is to support, not replace, the vital doctor-patient relationship.