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FAERS Signal Dossier

One drug. One finished safety report.

No dashboard to interpret. No code to run. One finished, citable PDF.

What you get

Give us one drug name. You get back a finished PDF: total primary-suspect reports, top adverse events by System Organ Class and Preferred Term, ROR and PRR with 95% confidence intervals, serious-outcome share with the missing-data share stated plainly, time-to-onset medians, reporting trends, and 1–2 same-class comparators — charts drawn from the same numbers as the tables, with methods, limitations, and source links.

Data: FDA FAERS public data — 26 million+ reports — with the data cut-off date stated on every report. Drugs and biologics only. Vaccines (VAERS) and devices (MAUDE) are out of scope.

Real sample — semaglutide vs tirzepatide

This is a complete, real dossier built from live OpenFDA data on 29 Oct 2026 — not a mock-up. Semaglutide as primary suspect: 72,856 reports, benchmarked against tirzepatide (160,201 reports), with yearly trend, top reaction terms, ROR/PRR signal statistics with 95% confidence intervals, serious-outcome mix, and the limits of the data stated plainly. Paid reports follow this exact format for your drug.

Download the free sample PDF

Why it beats the alternatives

OptionWhat you getWhat it lacks
FDA FAERS Dashboard & openFDAFree raw queries of the same public dataNo ROR/PRR signal statistics, no interpretation, no finished report
Enterprise pharmacovigilance platforms (Oracle Argus, Veeva Vault Safety, ArisGlobal)Full signal-management suites for pharma safety departmentsEnterprise contracts and implementation — priced for companies, not individuals
DIY — raw FAERS files + code librariesFull data access if you can code itNeeds a programmer and a statistician; no finished, readable PDF
FAERS Signal DossierOne finished PDFNothing missing for one drug

Pricing — pay via Stripe

$79 — Single-drug report
Pay $79 via Stripe

$179 — 3-drug bundle
Pay $179 via Stripe

$299 — Up to 5 drugs
Pay $299 via Stripe

After payment, send your drug name(s) and comparator preference to naviramdeen@gmail.com. Your finished, watermarked PDF is delivered to your email.

Video walkthrough

What this report is not

Not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration. FAERS data are public FDA data, analysed independently. A signal does not establish causation. FAERS cannot calculate population incidence because there is no exposure denominator. Reports are hypothesis-generating, not a prescribing recommendation and not investment advice.

Terms & Conditions

  1. Product. A finished PDF safety report for the drug(s) ordered, based on FDA FAERS public data as of the cut-off date stated in the report.
  2. Data source and cut-off. FAERS data are public FDA data, analysed independently. Quarterly files and the OpenFDA drug-event API carry a lag; the report states its cut-off date and does not claim real-time completeness.
  3. No medical advice. Reports are for research, publication writing, and safety review. They are not medical advice and not a prescribing recommendation.
  4. No investment advice. Reports are not investment advice or a recommendation to buy or sell any security.
  5. Signal, not causation. Disproportionality statistics (ROR, PRR) are signals. They do not establish that a drug caused an event, and they cannot calculate incidence without an exposure denominator.
  6. Limitations. FAERS has duplicates, missing outcomes, and reporting bias. The report states missing-data shares plainly and does not hide them.
  7. No FDA affiliation. No FDA logos are used and no FDA endorsement is claimed.
  8. Single-buyer licence. Each report is licensed to one buyer. Redistribution, resale, or public posting of a paid report is prohibited. Each paid report carries a buyer watermark and a report ID, which is the enforcement key.
  9. Delivery. Delivery is by email to the paying buyer's address, with a delivery log kept by the seller.
  10. Refunds. If the requested drug has no usable FAERS data, the buyer is told before delivery and a refund or substitute drug is offered. Once a correct finished report has been delivered, the fee is earned for the analysis performed.
  11. Privacy. Buyer details are used only to deliver and identify the report, and are not sold.

Who it helps

Researchers and medical writers, pharmacovigilance consultants, small pharma and medtech teams, journalists, investors, clinicians, and clinical trial designers — for research, safety review, class-benchmarked context, and future-trial safety planning.