finerenone

Score breakdown (76/100)

Safety: 95

• 4,886 FDA reports naming it as the suspect drug per million Medicare fills, 1.8x the median drug on this site (-5)
• Death share in reports is near or below the FAERS average (0.8x)

Evidence: 46

• 95 randomized trials and 27 systematic reviews/meta-analyses indexed in PubMed
• No Cochrane review found (-5)
• Only 21% of completed registered trials posted results (-15)

Regulatory history: 90

• No recalls on record since 2016
• Approved within the last 5 years: long-term safety is not yet known (-10)

Money & lawsuits: 70

• Pharma paid doctors $5,523,572 tied to this drug last year (-30)
• Not named in any pending federal MDL

Options: 70

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

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

4,886 reports blaming this drug for every million Medicare prescriptions filled, which is 1.8× the typical drug on this site. (1,972 reports in 2024–2026, against 403,577 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

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 $5,523,572 in payments to US physicians and hospitals tied to this drug across 117,647 transactions (Kerendia $5,523,572).

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

1 drug in the same class grades a letter or more higher than finerenone on this site. Worth asking whether one of them would do the same job for you.

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 glomerular filtration rate decreased, hyperkalaemia, blood creatinine increased, blood potassium increased. How would we recognize and handle those?
2. Why this one over canrenoate potassium, canrenone, eplerenone? What would make you pick one of those instead?
3. There is no generic. Is there an older generic in the same class that works as well for my situation?
4. The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?
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.)