Sold as Qelbree.
First FDA approval 04/02/2021: 5 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 (72/100)
Safety ×35%
A
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
C
Options ×10%
F
Safety: 100
Death share in reports is near or below the FAERS average (0.1x)
Evidence: 37
32 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed
No Cochrane review found (-5)
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 $4,364,969 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.
1,319reports that mention this drug
1,318of those blame this drug, not another one the person was taking
32%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
0.8%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.
Recalls and regulatory record
0recall actions on file
1 / 0brand / generic applications
1label changes since 2021
NoREMS program
Evidence base
32randomized trials (PubMed)
1systematic reviews
16registered trials
92%of completed trials posted results
0%terminated or withdrawn
100%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 $4,364,969 in payments to US physicians and hospitals tied to this drug across 61,140 transactions (Qelbree $4,364,969).
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
3,232Medicare Part D patients (2024)
11,851prescriptions filled
$574average cost per fill
$7Mtotal Medicare spend
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 headache, vomiting, migraine, nausea. 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.)