Gilotrif Side Effects
Generic name: afatinib
Note: This document contains side effect information about afatinib. Some dosage forms listed on this page may not apply to the brand name Gilotrif.
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. 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]
Frequently asked questions
- How long can I take Gilotrif (afatinib) for?
- Is Gilotrif (afatinib) a chemotherapy drug?
- How does Gilotrif (afatinib) work?
More about Gilotrif (afatinib)
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- During pregnancy
- FDA approval history
- Drug class: multikinase inhibitors
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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.
