Adverse Drug Reactions

ADR reporting, pharmacovigilance, and PvPI submissions

Reports (Jun)

44

Serious ADRs

4

CDSCO Reported

8

Pending Review

2

Amoxicillin-Clavulanate 625 mg

Severe
Certain
CDSCO Reported

Kavya Sharma, 34F · UH-2026-0712

Anaphylaxis — diffuse urticaria, angioedema, bronchospasm

Onset: 30 min after first doseReported: Dr. P. Sharma · 22 Jun 2026

Outcome: Recovered with adrenaline + antihistamine + IV steroids

Atorvastatin 40 mg

Moderate
Probable

Rajan Kumar, 58M · UH-2026-0744

Myalgia — diffuse muscle aches, CK elevated 3×ULN

Onset: 3 weeks after initiationReported: Ms. A. Singh (Pharmacist) · 20 Jun 2026

Outcome: Drug withheld. CK normalising. Rosuvastatin planned.

Metformin 1000 mg

Mild
Probable

Meera Pillai, 52F · UH-2026-0699

GI intolerance — nausea, bloating, diarrhoea

Onset: 1 week after dose increaseReported: Dr. A. Nair · 18 Jun 2026

Outcome: Dose reduced. Symptoms improving.