Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
Vol. 13, No. 4, 2014, pp. 617-620
Bioline Code: pr14089
Full paper language: English
Document type: Research Article
Document available free of charge
Tropical Journal of Pharmaceutical Research, Vol. 13, No. 4, 2014, pp. 617-620
© Copyright 2014 - Tropical Journal of Pharmaceutical Research
Safety of Oral Paracetamol – Analysis of Data from a Spontaneous Reporting System in Poland|
Han, Stanislaw; Kuchar, Ernest; Karłowicz-Bodalska, Katarzyna; Kutycka, Elżbieta; Miśkiewicz, Katarzyna & Nitsch-Osuch, Aneta
Purpose: To determine the safety of oral coated paracetamol tablets 500 mg and oral suspension 120
mg/5 mL produced by Hasco-Lek Poland.
Methods: We analyzed sales volume and data obtained from the monitoring of spontaneous reports on
the adverse effects of paracetamol collected in the period between November 2000 and June 2012.
Results: A total of 45,694 units of coated paracetamol tablets (500 mg) and 6,048,289 units of
paracetamol oral suspension (120 mg/5 mL) were marketed during that period. There were 4
spontaneous reports of adverse effects.
Conclusion: Oral paracetamol is a safe medication rarely causing adverse effects but it is possible that
the existing spontaneous monitoring system for adverse effects in Poland is not sensitive enough to
detect all adverse effects, and needs improvement.
Adverse reaction; NSAIDs; Pharmacovigillance; Pharmoepidemiology
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