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Background and purpose: Pharmacovigilance is defined as the science to detection, assessment, understanding and prevention of adverse drug reactions (ADRs). Spontaneous reporting is the cornerstone of the pharmacovigilance by filling out of Yellow Card by healthcare personnel. This study was conducted to evaluate the type, frequency and severity of ADR rising from Emam Khomeini Teaching Hospital. Also, this research aimed to inform the healthcare personnel and ultimately the manufactures thereby decreasing the frequency and severity of ADRs. Materials and methods: This descriptive study investigated 329 ADR yellow card reported in Emam Khomeini Teaching Hospital during 2004-2011. Statistical analysis was performed for frequency of ADRs , route of administration, reporters, number of reports in each year and affected organs. Results: Compared to other countries we observed lower rate of ADR reports. In this study injectable drugs were found with more side effects (49.54%), and nurses were top reporters (46.5%). Skin was the most affected area (39.2%). Antibiotics were the main drugs that caused ADR (42.55%) and vancomycin was the most prevalent one with side effects including rash, pruritus and hives. Conclusion: Avoiding unnecessary injections could be an important factor in reducing ADRs, increasing knowledge and attitude of healthcare workers regarding the probable risks and side effects. The importance of Pharmacovigilance system and taking approaches to rational prescribing of drugs especially antibiotics could be of great benefit in improving spontaneous reporting and pharmacotherapy.

Keywords: Pharmacovigilance, ADR, detection, assessment, yellow card

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