AdverseEvent.ai

What AdverseEvent.ai does

AdverseEvent.ai is a private, New York-headquartered pharmacovigilance SaaS platform that aggregates and analyzes public FDA Adverse Event Reporting System (FAERS) and Adverse Event Monitoring System (AEMS) data. The platform processes approximately 25 million drug adverse event reports and 8.5 million AEMS cases, offering free web-based analytics with no signup — including drug search, disproportionality analysis (PRR, ROR, chi-squared), time-series emerging-signal detection, and product comparisons. Coverage spans 100+ FDA-approved drugs with dedicated per-drug pages optimized for organic search, alongside a separate module for cosmetic adverse event reporting under MoCRA compliance.

The company's core paid offering is the FDA 3500A & E2B(R3) Report Builder, which generates validated electronic Individual Case Safety Reports (ICSRs) from scanned 3500A forms, research papers, or pasted intake notes, with XML validated against FDA's rulebook (well-formedness, XSD schema, ICH business rules, FDA regional rules) and direct submission via FDA's Electronic Submissions Gateway (ESG NextGen). A paid Drug Tracking & Weekly Updates service monitors literature and patient discussions for new adverse events on up to three drugs per account. Pricing starts at $99/month, targeting pharmacovigilance and regulatory affairs teams at small to mid-size drug companies, ANDA/NDA holders, manufacturers, and one-person safety departments — a long-tail segment typically underserved by enterprise systems such as Oracle Argus or Veeva Vault.

The business model is hybrid freemium-to-subscription: free analytics drive top-of-funnel acquisition among clinicians, researchers, patients, and journalists, while the E2B(R3) regulatory deadline of October 1, 2026 creates urgency-driven conversion into paid reporting tools. The company is early-stage (founded 2026, 1-10 employees), with no disclosed funding, management team, paying customer count, or revenue figures in the available source material.

Name

AdverseEvent.ai

Legal name

AdverseEvent.ai

Website

https://adverseevent.ai

Company type

Private

Founded year

2026

Operating status

Operating

Headcount range

1–10 employees

Short description

AdverseEvent.ai is a pharmacovigilance SaaS platform that provides free analytics on FDA FAERS/AEMS drug and cosmetic adverse event data, plus paid E2B(R3) XML reporting and drug monitoring tools targeting small-to-mid-size pharma safety teams.

Ownership category

akta.pro rank

Product category

Pharmacovigilance Software

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro industry

PRIMARYHLAGAJAK

Pharmacovigilance & Drug Safety Software

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Life Science Software & Informatics (LIMS/ELN/Bioinformatics)

SECONDARYHLACAKAK

Medication Safety, Pharmacovigilance & Adverse Event Reporting IT

Healthcare & Life Sciences/Digital Health & Health IT/ePrescribing, Medication Management & Pharmacy IT

Keywords

• Pharmacovigilance software
• FDA adverse event reporting
• Drug safety analytics
• E2B XML generation
• FAERS data analysis

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Marketing or Sales, Operations, Infrastructure

Revenue model

1. FAERS/AEMS Analytics (Free Tier): Free access to drug adverse event analytics including disproportionality analysis, time-series views, and product comparisons. No signup required. Generates user base of clinicians, researchers, patients, and journalists.
2. Drug Monitoring & Reporting (Paid): Paid subscription for drug tracking with weekly alerts on new adverse event reports, plus E2B(R3) XML generation for FDA submission. Targets pharmacovigilance and regulatory affairs teams. Pricing starts at $99/month.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels3 records

Core offering

AdverseEvent.ai is a web-based pharmacovigilance SaaS platform that aggregates and analyzes public FDA Adverse Event Reporting System (FAERS/AEMS) data, providing free drug safety analytics tools and paid reporting tools for generating validated E2B(R3) XML and FDA 3500A submissions. The platform covers both drug adverse events (~25M+ reports) and cosmetic adverse events under MoCRA compliance, targeting small and mid-size pharmaceutical companies with mandatory FDA reporting obligations as well as clinicians, researchers, and patients via its free tier.

Product overview

AdverseEvent.ai is a pharmacovigilance SaaS platform offering both free and paid tools. The free tier includes FAERS/AEMS Analytics for searching and analyzing FDA adverse event data, plus individual drug and cosmetic product pages with reaction reports. The paid tier centers on the FDA 3500A & E2B(R3) Report Builder for generating validated electronic submissions, and Drug Tracking & Weekly Updates for monitoring literature on specific drugs. The platform covers both prescription/OTC drugs (sourced from FDA's FAERS/AEMS database) and cosmetic products (under MoCRA requirements), with data coded in MedDRA terminology.

Differentiator

Problem solved

Functional benefit

Products and services

• FAERS/AEMS Analytics Free web-based analytics platform that lets users search and analyze FDA adverse event data sourced from the FAERS/AEMS public databases. Provides disproportionality analysis using PRR, ROR, and Yates-corrected chi-squared metrics, time-series views, drug comparison tools, and patient demographic breakdowns across drugs and cosmetic products. Available to anyone with no signup required.
• FDA 3500A & E2B(R3) Report Builder Paid pharmacovigilance workflow tool for generating validated FDA Form 3500A submissions and E2B(R3) ICSR XML for electronic transmission to the FDA. Supports intake from scanned 3500A forms, research papers, or pasted intake notes, with field-by-field extraction and source verification, and validation against FDA's XML well-formedness, XSD schema, ICH business rules, and FDA regional rules. Pricing starts at $99/month.
• Drug Tracking & Weekly Updates Paid weekly alert service that monitors new research papers, preprints, and patient discussions for adverse events on user-specified drugs. Covers up to three drugs per account and is included as part of the paid subscription tier.
• Cosmetic Adverse Event Reporting Tools for cosmetic product adverse event reporting under FDA's Modernization of Cosmetics Regulation Act (MoCRA). Includes a free reporting form for consumers and health professionals and paid tooling for cosmetic manufacturers ("responsible persons") to file MoCRA-compliant serious adverse event reports to the FDA within the mandated 15-business-day window. Covers all 13 FDA-defined cosmetic product categories per 21 CFR Part 720.

Quantifiable outcome

• Analytics platform is free with no signup required
• +1 more outcomes

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• IQVIA Safety Technologies: IQVIA offers end-to-end pharmacovigilance services and safety technology across case processing, aggregate reporting, and E2B submissions — overlapping with AdverseEvent.ai's report builder while operating as a much larger CRO+technology incumbent.
• Veeva Systems: Veeva's broader life sciences cloud (CTMS, Vault, CRM) is increasingly the default platform for emerging biotech — competing with AdverseEvent.ai at the account level even though its dedicated safety product is the more direct comparison.
• Medidata Rave Safety: Medidata (Dassault Systèmes) provides Rave Safety for clinical trial and post-marketing AE management, competing with AdverseEvent.ai's report builder primarily for sponsors already standardized on Medidata's clinical platform.
• Sparta Systems TrackWise (Honeywell): Honeywell's TrackWise quality and safety management platform handles complaint and adverse event workflows for life sciences — competing with AdverseEvent.ai for adverse event capture and reporting workflows at larger manufacturers.

Direct peers

• EXTEDO: EXTEDO specializes in regulatory submission management and pharmacovigilance software including E2B(R3) gateways and safety databases — directly addressing the same FDA ESG compliance workflow that AdverseEvent.ai targets.
• AB Cube SafetyEasy: AB Cube's SafetyEasy is a pharmacovigilance platform focused on case management, E2B(R3) submission, and signal detection for mid-size pharma — a comparable scope and buyer profile to AdverseEvent.ai's paid reporting offering.
• Oracle Argus Safety: Oracle Health Sciences' Argus Safety is the legacy enterprise standard for ICSR management, E2B(R3) XML generation, and global regulatory reporting — competing head-to-head with AdverseEvent.ai's paid reporting tier for mid-to-large pharma safety departments.
• ArisGlobal LifeSphere Safety: ArisGlobal's LifeSphere Safety is a modern cloud-native PV platform covering case intake, E2B(R3) submission, and signal detection — a like-for-like alternative to AdverseEvent.ai for both large and emerging pharma sponsors.
• Veeva Vault Safety: Veeva's Vault Safety suite is the leading cloud pharmacovigilance platform for adverse event case processing, E2B(R3) submission, and signal management — directly competing with AdverseEvent.ai's report builder for the same pharma/biotech buyers.

Emerging players

• RxNav / OpenVigil: OpenVigil is a free academic tool for FAERS disproportionality analysis (PRR/ROR) — overlapping with AdverseEvent.ai's free analytics tier and representing the open-source alternative that the company must differentiate against.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about AdverseEvent.ai