<p><strong>Diarrhea</strong>: Diarrhea may result in dehydration and renal failure. Withhold afatinib for severe and prolonged diarrhea not responsive to anti-diarrheal agents.<br />
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<strong>Bullous and exfoliative skin disorders</strong>: Severe bullous, blistering, and exfoliating lesions occurred in 0.2% of patients. Discontinue for life-threatening cutaneous reactions. Withhold afatinib for severe and prolonged cutaneous reactions.<br />
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<strong>Interstitial lung disease (ILD)</strong>: Occurs in 1.6% of patients. Withhold afatinib for acute onset or worsening of pulmonary symptoms. Discontinue afatinib if ILD is diagnosed.<br />
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<strong>Hepatic toxicity</strong>: Fatal hepatic impairment occurs in 0.2% of patients. Monitor with periodic liver testing. Withhold or discontinue afatinib for severe or worsening liver tests.<br />
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<strong>Keratitis</strong>: Occurs in 0.7% of patients. Withhold afatinib for keratitis evaluation. Withhold or discontinue afatinib for confirmed ulcerative keratitis.<br />
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<strong>Embryo-fetal toxicity</strong>: Can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to the fetus and to use effective contraception.</p>