Adverse Drug Reactions

ADR reporting, causality assessment, and pharmacovigilance

All ADRs must be reported to PvPI (Pharmacovigilance Programme of India) within 15 days. Serious ADRs within 7 days.

Total ADRs

3

Severe / Fatal

1

Reported to PvPI

2

Definite Causality

1

ADR-2026-041 — Priya Sharma, 34F

IV Cefazolin 1g · Onset: 5 min post infusion · Causality: Definite

Reaction: Anaphylaxis — urticaria, hypotension (BP 80/50), throat tightness

Outcome: Treated with IM Adrenaline + IV Hydrocortisone. Recovered. Penicillin/Cephalosporin ALLERGY documented.

Reported to: PvPI

Severe

ADR-2026-040 — Gopal Mehta, 45M

Meropenem 1g IV · Onset: Day 3 of therapy · Causality: Probable

Reaction: Generalised maculopapular rash — not anaphylaxis

Outcome: Drug continued under dermatology review (carbapenem critical, no substitute). Antihistamine added. Rash resolved day 6.

Reported to: Internal Only

Moderate

ADR-2026-039 — Sushila Mehta, 82F

Amiodarone 200 mg OD · Onset: 6 months of therapy · Causality: Probable

Reaction: Thyroid function derangement — TSH 0.02 (hyperthyroidism)

Outcome: Endocrinology review. Amiodarone dose reviewed. Carbimazole started.

Reported to: PvPI

Moderate