tooluniverse-adverse-event-detection

Detects adverse drug event signals using FAERS disproportionality analysis and FDA label data.

Updated Mar 13, 2026
One-click install
npx skills add https://github.com/matt-grain/pharma-catalyst --skill tooluniverse-adverse-event-detection-matt-grain
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: tooluniverse-adverse-event-detection
Source: https://github.com/matt-grain/pharma-catalyst/tree/main/.claude/skills/tooluniverse-adverse-event-detection
Command: npx skills add https://github.com/matt-grain/pharma-catalyst --skill tooluniverse-adverse-event-detection-matt-grain

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill requires tooluniverse.

What problem does it solve? Pharmacovigilance teams need to detect and quantify adverse drug event signals from post-market surveillance data, but manually querying FAERS, calculating disproportionality metrics, and cross-referencing FDA labels is slow and error-prone. ## Core Features & Use Cases - Disproportionality Signal Detection: Calculates PRR, ROR, and IC with 95% confidence intervals for each adverse event, classifying signal strength as Strong, Moderate, Weak, or None. - Multi-Source Triangulation: Combines FAERS reports, FDA label sections (boxed warnings, contraindications, interactions), OpenTargets, DrugBank, PharmGKB, and PubMed literature into one analysis. - Quantitative Safety Signal Score: Produces a 0-100 risk score with T1-T4 evidence grading for regulatory and clinical decision-making. - Use Case: Ask whether pembrolizumab is associated with myocarditis and receive the PRR/ROR/IC statistics, demographic stratification, FDA label context, and supporting literature in a structured markdown report. ## Quick Start Detect adverse event signals for atorvastatin and generate a full pharmacovigilance report with a Safety Signal Score.

Frequently Asked Questions about tooluniverse-adverse-event-detection

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I detect adverse event signals for a drug using FAERS data?▼

Provide the generic drug name and the skill resolves it to a ChEMBL ID, queries FAERS for top adverse events, then calculates PRR, ROR, and IC with 95% confidence intervals for each event. A signal is detected when PRR is at least 2.0, the lower confidence interval exceeds 1.0, and case count is at least 3.

What is disproportionality analysis in pharmacovigilance?▼

Disproportionality analysis compares the reporting rate of a specific adverse event for a drug against all other drugs in FAERS using metrics like PRR, ROR, and IC. PRR of 5.0 or higher indicates a strong signal requiring investigation, while 2.0-2.9 indicates a weak signal.

Can I compare safety profiles between two drugs like apixaban vs warfarin?▼

Yes, the FAERS_compare_drugs tool calculates PRR, ROR, and IC side-by-side for two drugs on a specific adverse event such as haemorrhage. You can also aggregate adverse reactions across an entire drug class to distinguish drug-specific from class-wide signals.

What happens if a drug has no FAERS reports or no boxed warning?▼

For drugs with no FAERS reports, the workflow skips FAERS phases and relies on FDA label data, mechanism-based predictions, and literature evidence. A NOT_FOUND error from FDA label tools is normal and simply means that section, such as a boxed warning, does not exist.

How is the Safety Signal Score calculated?▼

The score sums four components: FAERS signal strength (0-35 points), serious adverse events like deaths (0-30 points), FDA label warnings such as boxed warnings (0-25 points), and literature evidence (0-10 points). Scores of 75-100 indicate high concern requiring regulatory attention.

What drug name format should I use for FAERS queries?▼

Use generic drug names in uppercase for FAERS queries, such as ATORVASTATIN, and MedDRA preferred terms for specific events, such as Rhabdomyolysis rather than informal descriptions. The skill resolves names to ChEMBL and DrugBank identifiers automatically.