Summary

Commonly reported side effects of afatinib include: diarrhea, abnormal hepatic function tests, acneiform eruption, skin rash, and erythema of skin. Other side effects include: palmar-plantar erythrodysesthesia, and renal insufficiency. Continue reading for a comprehensive list of adverse effects.

Applies to afatinib: oral tablets.

Side effects include:

Adverse reactions occurring in ≥20% of patients: Diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, pruritus.

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]