Objective: This study retrospectively analyzed the risk of interstitial lung disease with cetuximab using risk factors known to be associated with interstitial lung disease during administration of epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI). Summary of background data: Cetuximab is an inhibitor of EGFR commonly used for advanced squamous cell carcinoma of the head and neck. Interstitial lung disease is a rare but serious adverse event of cetuximab. EGFR-TKIs are molecularly targeted drugs resembling cetuximab and show increased risk of interstitial lung disease associated with positive smoking history, age >55 years, preexisting lung disorder, and poor performance status. Methods: Among 44 patients treated with cetuximab for advanced squamous cell carcinoma of the head and neck between March 2013 and April 2015 at Tokyo Medical University, 6 patients developed interstitial lung disease. Smoking history, age, preexisting lung disorder, and performance status were examined for these 6 patients. Results: Two of these 6 patients died due to interstitial lung disease. All patients with interstitial lung disease were >55 years old and had a history of smoking. Three patients with interstitial lung disease had a preexisting lung disorder. Performance status was 0 in 4 patients and 1 in 2 patients. Conclusions: Age >55 years, smoking history, and preexisting lung disease may represent risk factors for interstitial lung disease during cetuximab treatment for head and neck carcinoma, whereas performance status may not.