Sold as Darzalex.
Class: CD38 (Clusters of Differentiation 38) inhibitors.
First FDA approval 11/16/2015: 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.
B
Score breakdown (81/100)
Safety ×35%
A
Evidence ×25%
C
Regulatory ×15%
A
Money & lawsuits ×15%
C
Options ×10%
D
Safety: 95
Death share in reports is near or below the FAERS average (1.4x)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 65
90 randomized trials and 25 systematic reviews/meta-analyses indexed in PubMed
1 independent Cochrane review(s) exist
Regulatory history: 100
No recalls on record since 2016
Money & lawsuits: 70
Pharma paid doctors $2,764,033 tied to this drug last year (-30)
Not named in any pending federal MDL
Options: 60
No generic version approved: brand-only pricing (-30)
1 same-class alternative(s) (-10)
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.
39,864reports that mention this drug
39,833of those blame this drug, not another one the person was taking
85%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
12.7%of reports include a death, from any cause (average for all drugs: 9.1%)
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.
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 $2,764,033 in payments to US physicians and hospitals tied to this drug across 14,092 transactions (Darzalex $2,764,033).
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
201Medicare Part D patients (2024)
1,702prescriptions filled
$10,579average cost per fill
$18Mtotal Medicare spend
Same-class alternatives
isatuximab
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
The most-reported problems in FDA's adverse event data are plasma cell myeloma, infusion related reaction, pneumonia. How would we recognize and handle those?
Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
Why this one over isatuximab? What would make you pick one of those instead?
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.)