triptorelin

Score breakdown (78/100)

Safety: 95

• Death share in reports is near or below the FAERS average (1.2x)
• Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)

Evidence: 35

• 56 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed
• On the WHO Model List of Essential Medicines (shown for context; no score effect)
• No Cochrane review found (-5)
• Only 38% of completed registered trials posted results (-8)

Regulatory history: 92

• No recalls on record since 2016
• 21 label changes approved since 2021: the safety story is still moving (-8)

Money & lawsuits: 100

• Pharma paid doctors $23,065 tied to this drug last year: negligible
• Not named in any pending federal MDL

Options: 70

• No generic version approved: brand-only pricing (-30)
• 4 same-class alternatives exist

Independent reviews and post-approval warnings

WHO Essential Medicine

Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.

What the FDA label says

Approved uses

Not available.

Contraindications

None listed.

Source: FDA SPL label, effective .

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

Problems reported most often

Reports per year

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

Evidence base

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $23,065 in payments to US physicians and hospitals tied to this drug across 677 transactions (Triptodur $23,065).

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

Same-class alternatives

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

1. The most-reported problems in FDA's adverse event data are death, ovarian hyperstimulation syndrome, needle issue. How would we recognize and handle those?
2. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
3. Why this one over buserelin, goserelin, histrelin? What would make you pick one of those instead?
4. There is no generic. Is there an older generic in the same class that works as well for my situation?
5. What result are we expecting, by when, and what is the plan if it does not happen?
6. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)