Table. Description of cases of ibuprofen associated hypothermia (RNF)

Case # Age/S Suspect drugs Ibuprofen Indication Dechallenge* Time ADR T (C°) Concomitant ex daily dose onset drugs (hours) 1 6 m/M Ibuprofen 60 mg Otitis + 2 Hypothermia <35° No Betamethasone Chills Sweating 2 10 Ibuprofen 80 mg Fever - 24 Hypothermia ND No m/M 3 10 Ibuprofen 100 mg Fever ND < 24 Hypothermia 34° No m/M 4 11 Ibuprofen 270 mg** Fever + 24 Hypothermia ND Paracetamol m/F (125 mg) 5 1 y/F Ibuprofen 100 mg Fever + < 24 Hypothermia 34° No 6 1 y/M Ibuprofen 100 mg Gingivitis ND 24 Hypothermia 35,9° No Diarrhea 7 1 y/F Ibuprofen 100 mg Fever ND < 24 Hypothermia 34,5° Cefpodoxime Betamethasone Excessive sweating Paracetamol Bradyarrhythmia Pallor 8 1 y/F Ibuprofen 400 mg** Fever + < 24 Hypothermia 34° No Excessive sweating Pallor Asthenia 9 1 y/M Ibuprofen 90 mg Fever + < 24 Hypothermia ND No 10 1 y/M Ibuprofen 270 mg Infection of the + 24 Hypothermia 34,5° Paracetamol upper respiratory (125 mg) tract 11 1 y/M Ibuprofen 60 mg Otalgia ND 2 Hypothermia 34,9° No 12 2 y/F Ibuprofen 15mg/kg Oropharyngeal + 24 Hypothermia 35° No pain Dry cough 13 3 y/F Ibuprofen 20mg/kg Pharyngitis + < 24 Hypothermia ND No 14 3 y/M Ibuprofen 200 mg Fever - 6 Hypothermia <34° No Bradycardia 15 3 y/F Ibuprofen 100 mg Fever + < 24 Hypothermia 34,4° No 16 4 y/F Ibuprofen 200 mg Fever Not withdrawn 4 hours Hypothermia 33° Homeopathic 1 Paracetamol product (Pulsatilla) 17 4 y/F Ibuprofen 100 mg Myalgia + 8 hours Hypothermia <35° No 18 8 y/F Ibuprofen 480 mg Pharyngitis + 1 day Hypothermia ND No Asthenia 19 11 Ibuprofen 200 mg Pharyngitis + < 24 Hypothermia ND No y/M hours Asthenia Hypotension *Dechallenge + : improvement of the reaction after stopping the drug - : no improvement of the reaction after stopping the drug ND: not detected (no information available) **Cases of overdose

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