FAERS manufacturer drug profile
SERTRALINE · NOVARTIS
FAERS manufacturer and drug safety profile
Key facts
| Drug | SERTRALINE |
|---|---|
| Manufacturer (report sender) | NOVARTIS |
At a glance
- 1,000+ FAERS reports from this manufacturer
- 100–999 Reports with death as outcome
- 1,000+ Reports with hospitalization
- 100–999 Life-threatening outcomes
- 1,000+ Distinct reaction terms reported
- 1,000+ Reactions flagged by Orca1 signal analytics
- Yes Serious outcome flagged by Orca1 signal analytics
- Other Serious, Hospitalization, Death, Life-Threatening, Disability, Congenital Anomaly Outcome categories reported
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FAERS manufacturer and drug safety profiles
Manufacturer drug profiles aggregate the FAERS reports that one manufacturer sent to the FDA naming the drug as a suspect product, so the same drug can be compared across manufacturers. Reaction terms are counted but not listed here; reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), FAERS public data; aggregation by Orca1