Sold as Repatha.
First FDA approval 08/27/2015: 11 years on the US market.
This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
C
Score breakdown (75/100)
Safety ×35%
B
Evidence ×25%
D
Regulatory ×15%
A
Money & lawsuits ×15%
C
Options ×10%
F
Safety: 85
17,568 FDA reports naming it as the suspect drug per million Medicare fills, 6.3x the median drug on this site (-15)
Death share in reports is near or below the FAERS average (0.1x)
Evidence: 62
102 randomized trials and 28 systematic reviews/meta-analyses indexed in PubMed
No Cochrane review found (-5)
Regulatory history: 100
No recalls on record since 2016
Money & lawsuits: 70
Pharma paid doctors $5,741,285 tied to this drug last year (-30)
Not named in any pending federal MDL
Options: 40
No generic version approved: brand-only pricing (-30)
No same-class alternatives found: little leverage to switch (-30)
What the FDA label says
Approved uses
Not available.
Contraindications
None listed.
Warnings and precautions
Not available.
Adverse reactions (label)
Not available.
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.
161,420reports that mention this drug
161,404of those blame this drug, not another one the person was taking
17%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
1.3%of reports include a death, from any cause (average for all drugs: 9.1%)
Problems reported most often
Device Difficult To Use · 32,925Drug Dose Omission By Device · 24,638Wrong Technique In Product Usage Process · 22,365Accidental Exposure To Product · 16,804Injection Site Pain · 10,927Product Storage Error · 6,676Back Pain · 5,587Myalgia · 5,422Drug Dose Omission · 4,929Injection Site Bruising · 4,800Device Use Error · 4,250Arthralgia · 4,061Fatigue · 4,061Injection Site Haemorrhage · 4,029Off Label Use · 3,936
Reports per year
2019
2020
2021
2022
2023
2024
2025
2026
9,722
8,998
10,476
12,349
24,557
25,528
7,905
6,033
17,568 reports blaming this drug for every million Medicare prescriptions filled, which is 6.3× the typical drug on this site. (39,454 reports in 2024–2026, against 2,245,760 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
0recall actions on file
0 / 0brand / generic applications
0label changes since 2021
NoREMS program
Evidence base
102randomized trials (PubMed)
28systematic reviews
165registered trials
74%of completed trials posted results
12%terminated or withdrawn
52%industry-funded
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 $5,741,285 in payments to US physicians and hospitals tied to this drug across 77,193 transactions (Repatha $5,741,285).
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
459,932Medicare Part D patients (2024)
2,245,760prescriptions filled
$874average cost per fill
$1,962Mtotal Medicare spend
Product
Fills
$/fill
Repatha Sureclick
1,943,941
$879
Repatha Syringe
233,776
$838
Repatha Pushtronex
68,043
$831
Same-class alternatives
No same-class alternatives found in RxClass.
Questions to ask your prescriber
The most-reported problems in FDA's adverse event data are device difficult to use, drug dose omission by device, wrong technique in product usage process, accidental exposure to product. How would we recognize and handle those?
There is no generic. Is there an older generic in the same class that works as well for my situation?
The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?
What result are we expecting, by when, and what is the plan if it does not happen?
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.)