Gilotrif Side Effects

Generic name: afatinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 7, 2025.

Note: This document provides detailed information about Gilotrif.

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

Applies to afatinib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 2 weeks after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if diarrhea occurs while taking this medicine. You may need medicines to help manage or prevent the diarrhea.

Skin reactions (eg, acne, rash, or skin redness) may occur while you are using this medicine. Check with your doctor right away if you develop severe skin reactions, such as blistering or peeling of the skin, or severe rash. Also, avoid overexposing your skin to sunlight. Always use sunscreen or sun blocking lotions and wear protective clothing and hats while you are using this medicine.

Check with your doctor right away if you start having breathing problems, shortness of breath, cough, chest pain, fever, or chills. These could be symptoms of a serious lung problem.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Stomach or bowel perforation may occur while you are using this medicine. Tell your doctor right away if you have severe abdominal or stomach pain, bloody, black, or tarry stools, heartburn, or vomiting of material that looks like coffee grounds.

Check with your doctor right away if you have vision changes, such as blurred vision, difficulty reading, or eye pain, irritation, or swelling, during or after treatment. Your doctor may want you to have your eyes checked by an eye doctor (ophthalmologist). Also, tell your doctor if you wear contact lenses.

Check with your doctor right away if you have trouble breathing, cough, fast or uneven heartbeat, rapid weight gain, swelling of your ankles or legs, or unusual tiredness or weakness.

Talk with your doctor before using this medicine if you plan to have children. This medicine may cause infertility in men and women (unable to have children).

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 (eg, St. John's wort) or vitamin supplements.

Serious side effects of Gilotrif

Along with its needed effects, afatinib (the active ingredient contained in Gilotrif) 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 afatinib:

Get emergency help immediately if any of the following symptoms of overdose occur while taking afatinib:

Symptoms of overdose

• dizziness
• headache
• lack or loss of strength
• stomach pain
• vomiting

Other side effects of Gilotrif

Some side effects of afatinib 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 afatinib: oral tablet.

Gastrointestinal adverse events

• Very common (10% or more): Diarrhea (96%), stomatitis (71%), cheilitis (12%), nausea, vomiting
• Common (1% to 10%): Dyspepsia
• Uncommon (0.1% to 1%): Pancreatitis^[Ref]

Dermatologic

• Very common (10% or more): Acneiform rash/dermatitis (90%), paronychia (58%), dry skin (31%), pruritus (21%), alopecia (13%)
• Common (1% to 10%): Palmar-plantar erythrodysesthesia syndrome, nail disorders
• Uncommon (0.1% to 1%): Bullous, blistering, and exfoliating lesions
• Rare (0.01% to 0.1%): Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)^[Ref]

Genitourinary

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

Hepatic

• Very common (10% or more): Alanine aminotransferase increased (11%)
• Common (1% to 10%): Aspartate aminotransferase increased^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (29%), weight decreased (17%)
• Common (1% to 10%): Dehydration, hypokalemia^[Ref]

Ocular

• Very common (10% or more): Conjunctivitis (11%)
• Common (1% to 10%): Dry eye
• Uncommon (0.1% to 1%): Keratitis (e.g., acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye)^[Ref]

Other

• Very common (10% or more): Fatigue (19%), pyrexia (12%)^[Ref]

Respiratory

• Very common (10% or more): Epistaxis (17%), nasopharyngitis (14%), rhinorrhea (11%)
• Uncommon (0.1% to 1%): Interstitial lung disease (ILD) or ILD-like adverse reactions (e.g., lung infiltration, pneumonitis, acute respiratory distress syndrome, alveolitis allergic)^[Ref]

Musculoskeletal

• Common (1% to 10%): Muscle spasm^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (15%)^[Ref]

Nervous system

• Very common (10% or more): Headache (14%), dizziness (11%)
• Common (1% to 10%): Dysgeusia^[Ref]

Renal

• Common (1% to 10%): Renal impairment/renal failure^[Ref]

See also:

Frequently asked questions

• How long can I take Gilotrif (afatinib) for?
• Is Gilotrif (afatinib) a chemotherapy drug?
• How does Gilotrif (afatinib) work?

Further information

Gilotrif 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