• Naruemon Bamrungsawad Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok
  • Nilawan Upakdee Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok
  • Chuenjid Kongkaew Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok
  • Anjana Fuangchan Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok
  • Pakawadee Sriphiromya Rural and Local Consumer Health Products Promotion Protection Division, Food and Drug Administration, Ministry of Public Health, Nonthaburi
Keywords: topical non-steroidal anti-inflammatory drugs (NSAIDs), adverse events, Thai Vigibase


This study sought to determine the characteristics of adverse events (AEs) reported in patients using topical non-steroidal anti-inflammatory drugs (NSAIDs) in Thailand as per the Thai Health Product Vigilance Center Database (Thai Vigibase). All AE reports from 1984 to 2016, involving topical NSAIDs and registered in Thailand, were retrieved from the Thai Vigibase. The following information on patient demographics was extracted from each report: age, gender, history of drug allergy, concomitant diseases, suspected drugs, timing of drug exposure, concomitant drugs, suspected reactions, time to onset of AEs, seriousness, and causality assessment. Descriptive statistics were used for data analyses. Results identified 179 AEs as reported by hospitals. The mean age was 47.2±17.2 years and 56.4% were female. Diclofenac (49.2%), ketoprofen (25.4%), and piroxicam (21.5%) were the three most commonly suspected drugs. Eighteen AE reports (10.1%) were classified as serious with 14 cases (7.8%) requiring hospitalization or prolonged hospitalization, and 2 cases (1.1%) resulted in death related to toxic epidermal necrolysis (TEN) and eczema. Of the 179 total reports, 249 AEs were found. Overall, skin and appendage disorders were the most common AEs reported (77.1%), followed by the body as whole - general disorders (8.8%), application site disorders (6.8%), gastrointestinal system disorders (2.4%), and disorders of the central and peripheral nervous system (1.6%). Most AEs (88.9%) occurred during the first week of treatment, of which 39.2% manifested within 24 hours after application. The causality of most reported events was classified as probable (57.5%). The most frequent skin AEs were pruritus and rash. In conclusion, topical NSAIDs were potentially associated with a risk of skin AEs. However, systemic AEs were uncommon. Further studies are needed to investigate the safety of topical NSAIDs for long-time use and in patients with severe or unstable comorbidities.


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