Azithromycin is an antibiotic that belongs to the macrolide family used in a wide variety of bacterial diseases. However, it has been proposed as a potential therapy for the treatment of SARS-CoV-2 pneumonia (off-label use) given for its antiviral and   immunomodulatory activity. Never-theless, its role in the treatment of COVID-19 remains unclear. Azithromycin has a well-characterized safety profile. However, its use outside the approved indication needs further follow up to ensure that the benefit-risk balance remains positive. One method to look for new/ changed safety information is through using the information component (IC025) value. IC025 is the lower limit of a 95% credibility interval for the IC. The credibility interval provides information about the stability of a particular IC value: the narrower the interval, the higher the stability. Objective: Study the submitted adverse events reports of Azithromycin to the Iraqi Pharmacovigilance center and compare the occurrence of these reported adverse events in Iraq to the internationally reported cases during 2020COVID-19 pandemic using IC025.   Methodology: The reported adverse events of Azithromycin to the national Pharmacovigilance database were studied qualitatively (age, gender and seriousness) and quantitatively (using IC025) as a measure of presence of a new/changed safety information related to Azithromycin.   Results: The total number of reports for Azithromycin were 419, female represent (43%) and male represent (55.8%), and the predominant age groups was from 45-64 years representing (41.1%). The most widely reported adverse events were gastrointestinal disorders (68%), cardiac disorders (14.1%), general disorders and administration site effect (6.9%), and investigations (Interfere with Lab tests) (5.7%). There were 96 drug-adverse reaction combinations. The IC025 value for the most widely reported adverse events showed a comparable value for ECG-QT prolonged (3.6/3.7), Arrhythmia (0.6/0.7). There was a decreased value for palpitation (0.5/0.9) and dyspnea (0.3/0.6). Tachycardia and increased liver enzymes showed an increased value of (2.0/0.1) and (0.5/0.1) respectively.   Conclusion: Using the IC025 was helpful in finding the increased reporting rate of adverse events compared to the background rate.

Background: Hydroxychloroquine is a long-used medication, most commonly used to treat and prevent malaria, that also has anti-inflammatory and antiviral characteristics. Therefore, specialists have shown interest in the underlying mechanism of its antiviral activity. In vitro experiments have demonstrated its efficiency against SARS coronavirus, and in vitro and in vivo research on coronavirus disease 2019 (COVID-19) is being conducted. We aimed to investigate reports on adverse events of hydroxychloroquine submitted to the Iraqi Pharmacovigilance Centre and compare the incidence of these reported adverse events in Iraq to globally reported cases during the COVID-19 pandemic in 2020 using information component (IC)025 values. Methods: The reported adverse events of hydroxychloroquine to the national Pharmacovigilance database, VigiBase™ a WHO global database of reported potential side effects of medicinal products, were investigated qualitatively (age, sex, and severity) and quantitatively (using IC025) as a measure of the existence of new/altered safety information associated with hydroxychloroquine. Results: A total of 132 reports were found, with women representing 37.1% and men representing 60.6% of cases, while the rest were unidentified, with the predominant age groups ranging from 18–44 years old accounting for 47.4% of cases. The most reported adverse events were upper (17%) and lower abdomen pain (21%), nausea (14%), diarrhea (13%), and electrocardiogram (ECG) QT prolongation (13%). There were 44 different drug-adverse reaction pairings in which the adverse reaction reports included more than one event. The IC025 value for the most widely reported adverse events showed a positive comparable value for upper (2/0.3) and lower abdominal pain (1.8/-0.0), palpitation (1.6/-0.4), and dyspepsia (1.1/0.6). There was a decreased value for IC025 in cases of ECG QT prolongation (3.5/5), diarrhea (0.3/0.8), abdominal discomfort (0.1/2), and oral fungal infection (-0.4/0.6). Conclusions: The IC025 helped determine the higher reporting rate of adverse events compared to the average global rates.