Pharmacovigilance
Drug safety, in real time.
Disproportionality analytics, MedDRA-coded ADR signals, recall feeds and regulatory communications — across FAERS, EudraVigilance, VigiBase, MHRA, Health Canada and Rwanda FDA.
Active signals
318
12 new this week
Recalls (90d)
47
+8%
ADR reports indexed
12.8M
+184k
Countries
118
WHO PIDM
Signal Detection · Disproportionality
Top ADR signals · 30 days
| Drug | Adverse event (MedDRA PT) | ROR | 95% CI | n | Source | Status |
|---|---|---|---|---|---|---|
| SGLT2 inhibitors | Fournier's gangrene | 4.2 | 3.1–5.7 | 218 | EudraVigilance | Under review |
| Semaglutide | Suicidal ideation | 1.1 | 0.9–1.4 | 142 | FAERS | Inconclusive |
| Montelukast | Neuropsychiatric events | 3.8 | 3.2–4.5 | 1024 | FAERS | Labelled |
| Valproate | Congenital malformations | 5.6 | 4.8–6.5 | 612 | MHRA | Black box |
| Tramadol | Serotonin syndrome | 2.9 | 2.4–3.5 | 386 | Rwanda FDA | Monitoring |
| Ivermectin (off-label) | Hepatotoxicity | 1.8 | 1.4–2.3 | 94 | WHO VigiBase | Investigating |
Recent Recalls & Safety Communications
- US FDA · United StatesClass II recall — losartan/HCTZ 100/25 mg, 4 lotsOut-of-specification NDMA impurity detected; 412,000 bottles affected
- EMA PRAC · European UnionSignal: SGLT2 inhibitors and Fournier's gangreneROR 4.2 (95% CI 3.1–5.7) in EudraVigilance; labelling review underway
- MHRA · United KingdomDSU: SSRIs and persistent sexual dysfunction — label updateAdded warning to all SSRI SmPCs; HCP communication issued
Report an ADR
Submit a structured pharmacovigilance report. We forward to your national centre and to WHO VigiBase.
Confidential · CIOMS-compliant · routed to Rwanda FDA, WHO UMC and originator MAH.