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Afatinib Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 15, 2022.

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. See below for a comprehensive list of adverse effects.

For the Consumer

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Gilotrif (afatinib)." Boehringer Ingelheim (2013):

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.