Vomiting and constipation associated with tramadol and codeine: a comparative study in VigiBase®
The most frequent adverse drug reactions (ADRs) of codeine and tramadol, the two main step 2 opioid analgesics, include nausea, dizziness, sedation, vomiting, and constipation . The relative importance of vomiting and constipation remains discussed [1, 2, 3]. We performed a comparative analysis of ADRs in VigiBase®, the World Health Organization Global Individual Case Safety Report (ICSR) database .
We used the disproportionality method [5, 6] including reports (age ≥ 18 years and gender known) registered from 1969 to 7 October 2017 under the MedDRA preferred terms “vomiting” or “constipation”. Drug exposure was identified using the anatomical therapeutic and clinical codes N02AX and N02AA, with drugs defined as “suspected” or “concomitant” [7, 8]. Associations of codeine or tramadol with antispasmodics (N02AG), other drugs (caffeine, barbiturates…) as well as the use of codeine + tramadol simultaneously were not included in the study. A sensitivity analysis compared tramadol +...
The authors would like to thank the Uppsala Monitoring Centre (UMC) which provided and gave permission to use the data analyzed in the present study. The authors are indebted to the National Pharmacovigilance Centers that contributed data. The opinions and conclusions in this study are not necessarily those of the various centers or of the WHO or ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé, France). The help of Doctor Christine Damase-Michel for reading the manuscript is acknowledged.
Compliance with ethical standards
The authors declare that they have no competing interests.
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