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FAERS: FDA Adverse Event Reporting System

Released quarterly by the FDACurrent to 2026-06-30
Ledger Suspect-drug records on file 50974773Reports in the latest quarter 352949Reports marked serious 58.9%

Live state of the FDA's post-market drug-safety surveillance feed: report volume, filer mix, and the substances and reactions named most often.

11,175,581
reports, live count
Added, trailing 7 d0
Added, trailing 30 d0
Most recent event2026-06-30
Update cadenceReleased quarterly by the FDA
Freshness Fresh · 7wk

Weekly volume

Trailing 18 weeks
475.5K02022-01-012024-04-012026-04-01

Reporter Type Mix

Share of reports filed by consumers, health professionals, and manufacturers, latest quarter.

Consumer or non-health professional196,081
Other health professional71,359
Physician55,281
Pharmacist17,883
Not specified12,345

Reported Outcome Mix

Most severe outcome flagged on each report, latest quarter.

Non-serious168,157
Other serious outcome95,860
Hospitalization54,474
Death22,509
Life-threatening8,682
Disability2,747
Congenital anomaly520

Leading Suspect Drugs

Active substances named as suspect drug on the most reports, latest quarter.

1DUPILUMAB39,720
2TIRZEPATIDE19,880
3SEMAGLUTIDE16,964
4ACETAMINOPHEN9,432
5MEDROXYPROGESTERONE ACETATE8,706
6PREDNISONE8,060
7ASPIRIN7,290
8AMLODIPINE BESYLATE6,592

Leading Reported Reaction Terms

MedDRA reaction terms named most often across reports, latest quarter.

Off label use19,437
Drug ineffective17,826
Nausea13,583
Product dose omission issue12,230
Diarrhoea12,101
Death11,969
Fatigue11,899
Pruritus10,348
Headache9,032
Meningioma8,392

Quarter-over-Quarter Movers

Suspect substances with the largest report-count change versus the prior quarter.

SEMAGLUTIDE
12,163
DUPILUMAB
10,610
MEDROXYPROGESTERONE ACETATE
7,071
COPPER
-4,719
ABALOPARATIDE
3,849
CABOZANTINIB S-MALATE
-3,028
ADAPALENE
-2,570
ACETAMINOPHEN
-2,471
BIMEKIZUMAB-BKZX
2,405
EVOLOCUMAB
2,052

Latest Filed Reports

The ten most recently received reports.

NUPLAZID — Hospitalisation
Received 2026-06-30
MOUNJARO — Pancreatitis
Received 2026-06-30
HUMIRA — Pain
Received 2026-06-30
QULIPTA — Dyspnoea
Received 2026-06-30
TRETINOIN — Visual impairment
Received 2026-06-30
RINVOQ — Gastric haemorrhage
Received 2026-06-30
LEVOCARNITINE\TIRZEPATIDE — Musculoskeletal stiffness
Received 2026-06-30
VANCOMYCIN — Renal injury
Received 2026-06-30
REZDIFFRA — Nausea
Received 2026-06-30
RINVOQ — Pneumonia
Received 2026-06-30

About this data. Figures are drawn directly from the source and refresh on its own update schedule.