Gilotrif Side Effects

Generic Name: afatinib

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

In Summary

Common side effects of Gilotrif include: diarrhea, abnormal hepatic function tests, acneiform eruption, skin rash, and erythema of skin. Other side effects include: palmar-plantar erythrodysesthesia, and renal insufficiency. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to afatinib: oral tablet

Side effects requiring immediate medical attention

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

Side effects not requiring immediate medical attention

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]

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]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer