Safety Profiling
Evaluate target safety liabilities early by consolidating pharmacovigilance signals, clinical adverse events, off-target activity, and class-wide patterns from a single query. Synapse aggregates FAERS post-market data across all drugs in the target's class, maps adverse events to organ systems, and distinguishes expected pharmacology from genuine safety concerns. No data upload required: just a target or compound name.
Deliverables
Organ-level risk assessment
A 12-organ risk grid combining FAERS pharmacovigilance signals with clinical trial adverse event data. Each organ system is classified as low, medium, or high risk based on event frequency, severity, and class-wide prevalence. For GLP1R, the assessment identified CNS and GI as medium-risk organ systems (class liabilities affecting 53% of drugs) with all other organs at low risk and no fatal signals detected.
Class liability analysis
Systematic identification of adverse event patterns shared across the drug class. For GLP1R, GI effects (nausea 51,812 reports, vomiting 25,805) and CNS effects (headache 11,385, dizziness 10,667) were flagged as class liabilities, meaning they are expected pharmacological consequences of GLP-1 receptor agonism, not compound-specific issues. This distinction is critical for regulatory safety narratives.
Detailed FAERS event breakdown
Event-level detail across all affected organ systems with report counts, drug prevalence ratios, and severity indicators. The breakdown covers 5 organ systems with quantified events, ranging from 51,812 nausea reports to 1,513 hypersensitivity reports. Each event links back to the drugs that generate it and the proportion of the class affected.
Flag target liabilities early, before they become expensive surprises downstream. Targets with only expected class effects and no novel safety signals are safer advancement candidates.
GLP1R safety profile: organ risk, class liabilities, and FAERS detail
| Event | Reports |
|---|---|
| Headache | 11,385 |
| Dizziness | 10,667 |
| Tremor | 3,397 |
| Insomnia | 3,129 |
| Somnolence | 2,364 |
| Event | Reports |
|---|---|
| Nausea | 51,812 |
| Vomiting | 25,805 |
| Diarrhoea | 24,558 |
| Constipation | 13,314 |
| Pancreatitis | 8,177 |
| Abdominal pain | 8,136 |
| Event | Reports |
|---|---|
| Injection site erythema | 7,028 |
| Pruritus | 4,427 |
| Rash | 3,885 |
| Alopecia | 3,286 |
| Event | Reports |
|---|---|
| UTI | 2,379 |
| Hypersensitivity | 1,513 |
| Event | Reports |
|---|---|
| Hypoglycaemia | 2,830 |
CROSS-TARGET SAFETY COMPARISON
| Target | Liabilities | Medium-Risk Organs | Fatal | FAERS Scale |
|---|---|---|---|---|
| GLP1R | 2 | CNS, GI | 0 | 51k max |
| IL4R | 7 | CNS, Derm, GI, Immune, MSK, Resp, Systemic | 0 | 48k max |
| IL13 | 6 | CNS, Derm, GI, Immune, MSK, Systemic | 0 | 40 max |
| Event | System | Reports |
|---|---|---|
| Arthralgia | Musculoskeletal | 40 |
| Diarrhoea | GI | 38 |
| Headache | CNS | 32 |
| UTI | Immune | 32 |
| Nausea | GI | 26 |
| Back pain | Musculoskeletal | 24 |
| Hypertension | Systemic | 24 |
IL13 FAERS counts are orders of magnitude lower than IL4R (40 vs 48,441 top event) reflecting fewer marketed drugs. Musculoskeletal prominence (arthralgia #1) contrasts with IL4R's dermatologic dominance (pruritus #1).
Methodology
Consolidate FAERS pharmacovigilance reports
Aggregate FAERS reports across all drugs in the target's class. For GLP1R, this covers 17 marketed drugs with post-market surveillance data, providing a comprehensive view of real-world safety signals.
Map adverse events to organ systems
Each reported adverse event is classified by organ system using MedDRA hierarchy mapping. Events are grouped and counted at both the organ level and individual event level for multi-resolution assessment.
Score organ-level risk
Risk scores incorporate event frequency, severity weighting, and drug class prevalence. Organs where adverse events appear across many drugs in the class receive higher risk scores than compound-specific signals.
Cross-reference with clinical trial data
FAERS signals are validated against reported adverse events from clinical trials in the ClinicalTrials.gov registry. Concordance between real-world and trial-reported signals increases confidence in the risk assessment.
Distinguish pharmacology from liabilities
Expected pharmacological effects (e.g., GI disturbance from GLP-1 agonism) are labeled as class effects. Novel signals absent from the class profile are flagged for further investigation. These are the true safety concerns.
Target personas
Safety scientist
Get a comprehensive, organ-level safety profile for any target class from pharmacovigilance and clinical data.
Clinical development lead
Anticipate safety signals before clinical trials. Design monitoring plans based on known class liabilities.
Regulatory affairs
Build safety narratives for regulatory submissions grounded in comprehensive post-market and clinical evidence.
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