Gilotrif Side Effects

Generic name: afatinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 5, 2024.

Note: This document contains side effect information about afatinib. Some dosage forms listed on this page may not apply to the brand name Gilotrif.

Applies to afatinib: oral tablet.

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:

More common

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

Cough
difficult breathing

Rare

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 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:

More common

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

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]