September 2022: Codeine with ibuprofen – EMA warning for serious renal and gastrointestinal harms
The European Medicine Agency Pharmacovigilance Risk Assessment Committee has recommended a change to the product information for codeine with ibuprofen combination medicines to include a warning of serious harms, including death, particularly when taken for prolonged periods at higher than recommended doses. The recommendation is based on several cases of renal, gastrointestinal and metabolic toxicities that have been reported in association with cases of abuse of and dependence from codeine with ibuprofen combinations, some of which have been fatal.
- TRADE NAMES: Actacode; Calcidrine; Cheracol; Codicept; Codiforton; Guiatuss AC; Halotussin (Watson); Novahistine DH; Nucofed (Monarch); Paveral; Robitussin AC (Wyeth); Solcodein; Tricodein; Tussar-2; Tussi-Organidin (MedPointe)
- INDICATIONS: Pain, cough suppressant
- SYNONYM: methylmorphine
- CLASS: Opiate agonist
- HALF-LIFE: 2.5–4 hours
- CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
Alcohol, Cinacalcet, CNS depressants, Delavirdine, MAO inhibitors, Mianserin, Terbinafine, Tipranavir
- See adverse reactions attributed to class:
DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE
See full prescribing information for complete boxed warning.
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Page last updated 05/03/2025
