Related Experiment Video
Updated: Jun 29, 2025

Author Spotlight: Exploring ShiDuGao's Multi-Target Approach in Anus Eczema Treatment
Published on: January 12, 2024
A Clinico-Epidemiological Study of Fixed Drug Eruption with a Special Focus on the Causative Agent and the Clinical
Dishari Halder1, Sudip Das1, Abhishek De1
1Department of Dermatology, Calcutta National Medical College, Kolkata, West Bengal, India.
Background:
Fixed drug reaction (FDE) is characterized by the development of well-circumscribed, round, erythematous macules and plaques on cutaneous or mucosal surface following ingestion of the offending drug.
Aim And Objectives:
To study the etiological agents responsible for FDE and to study the clinical patterns of FDE due to different drugs.
Materials And Methods:
It was a hospital-based observational cross-sectional clinical study. The study period was 24 months. Fifty patients were included. The study was done after a literature search, hypothesis generation, protocol write-up, ethical submission, ethical clearance, patient enrollment, data collection, data analysis, and research. The patients were selected on the basis of the Naranjo scoring system. The patients with a history of combination drug intake were not included in the study.
Results:
A total of 0.11% patients presented with FDE in the study period. Out of them, 52% of the patients belonged to 20-39 years age group, having sex ratio of 1.6:1. About 64% of the patients presented with multiple lesions, whereas 36% had a single lesion. A total of 46% patients presented with first episode and 54% had recurrent episodes. The mean time intervals of first and subsequent episodes were 6.5 days and 4.3 hours, respectively. Also, 16% patients had a history of herpes infection. Extremities were more affected followed by trunk and mucosa. Fluoroquinolones were the most common etiological agent found in 56% patients having cutaneous (48%) and mucosal lesions (14%). The most common drug was norfloxacin (36%) followed by both paracetamol (12%) and metronidazole (12%). Fluoroquinolones were the most common drugs implicated in bullous lesions and generalized bullous FDE.
Limitations:
The study population was small and the study was for a limited period of time.
Conclusion:
The patient should be aware of the offending drug and opt for any alternative agent after visiting the physician.
Related Concept Videos
Allergic Drug Reactions
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Clinical Trials: Overview
Drug Excretion: Miscellaneous Routes
Drug Administration and Therapy Phases: Overview
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Clinical Trials
There are four phases in a clinical trial. A phase one...

