Afatinib Side Effects

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

Applies to afatinib: oral tablet.

Serious side effects of afatinib

Along with its needed effects, afatinib 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:

More common side effects

• bloody or cloudy urine
• burning, dry, or itching eyes
• diarrhea
• difficult, burning, or painful urination
• discharge or excessive tearing
• fever
• frequent urge to urinate
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• tingling of the hands and feet
• ulceration of the skin

Less common side effects

• cough
• difficult breathing

Rare side effects

• bloody, black, or tarry stools
• heartburn
• indigestion
• nausea
• severe abdominal pain, cramping, or burning
• vomiting of material that looks like coffee grounds, severe and continuing

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 afatinib

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:

More common side effects

• blemishes on the skin
• canker sores
• chapped, red, or swollen lips
• decreased appetite
• decreased weight
• dry skin
• itching skin or rash
• loosening of the fingernails
• nosebleeds
• pimples
• redness or soreness around the fingernails
• runny nose
• scaling, redness, burning, pain, or other signs of inflammation of the lips
• sores, ulcers, or white spots on the lips or tongue or inside the mouth

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]

Frequently asked questions

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

Further information

Afatinib 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