Definition: Postmarketing experience is the part of a label, usually section 6.2, that lists side effects reported after a drug went on sale. FDA rules say these come from spontaneous reports in the US and abroad and are listed apart from trial results. Labels often say their frequency cannot be reliably estimated.
| Label | Reported after approval (examples) |
|---|---|
| Ozempic | Pancreatitis (sometimes fatal), bowel blockage, severe constipation, anaphylaxis, angioedema, gallbladder inflammation, acute kidney injury, hair loss, food entering the lungs during anesthesia |
| Menopur (reported with gonadotropins) | Lower abdominal pain and bloating, nausea, injection site pain, fatigue, pelvic pain, ovarian cyst, breast tenderness, acne, rash, hot flush |
The Ozempic label says the frequency of its postmarketing reports cannot be reliably estimated.
FDA collects adverse event reports, medication error reports and product quality complaints in its reporting system, which it uses for safety monitoring after approval. Its current page calls it the FDA Adverse Event Monitoring System, formerly FAERS. The NCI describes phase IV trials as studies of side effects over time after a drug is on the market; see clinical trial phases.
Postmarketing reports are how rare problems not seen in trials come to light. A clear record of the product, lot, dose dates and what happened is what makes any report useful.
Read more on Dose Track: Ozempic side effects · Menopur side effects · Side effects from FDA labels