Safety Profile Overview
The original SSRI that revolutionized depression treatment. Long half-life provides unique pharmacokinetic advantages and easier discontinuation.
Generic Name
fluoxetine
Brand Names
Prozac
Therapeutic Class
SSRI
Manufacturer
Eli Lilly
What Pharma Signal Tracks for Fluoxetine
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Fluoxetine, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Fluoxetine products.
- Label Changes — Boxed warning additions, new contraindications, dosing modifications, and safety-related labeling supplements.
- Risk Score — Composite risk score (0–100) combining adverse event rates, recall history, and label severity with explainable breakdown.
- Pharmacovigilance Signals — Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR) analysis detecting disproportionate adverse reactions.
- Trend Analysis — Monthly time series with anomaly detection for emerging safety signals.
Data Disclaimer: Pharma Signal aggregates data from the FDA Adverse Event Reporting System (FAERS) and other public regulatory sources. FAERS reports do not establish causation. Report counts may reflect prescription volume rather than relative safety. Always consult healthcare professionals for medical decisions.
Get Fluoxetine Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Fluoxetine.
curl "https://api.pharma-signal.com/drug/safety/fluoxetine" \ -H "X-API-Key: your_key" # Returns risk score, adverse event counts, # serious/death rates, recalls, and signals
Related Safety Intelligence
Pharma Signal provides comparative analysis across therapeutic classes. Compare Fluoxetine against other SSRI drugs, or explore the full manufacturer portfolio for Eli Lilly.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Fluoxetine ranks within SSRI on serious event rates.
- Company portfolio risk — View all drugs from Eli Lilly with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.