buprenorphine / naloxone

What is in it

Each ingredient has its own full page with the FDA label, side-effect reports, recalls, evidence, and payments. Open them for the detail behind this grade.

Score breakdown (64/100)

Safety: 56

• Graded by its riskiest ingredient, buprenorphine (56)
• 11,600 FDA reports naming it as the suspect drug per million Medicare fills, 4.2x the median drug on this site (-12)
• Subject to a REMS safety program: FDA requires special controls to use it (-10)
• Federally controlled substance: dependence and misuse risk (-10)
• Death appears in 3.2x the share of reports seen across all of FAERS (-12)

Evidence: 76

• Graded by its riskiest ingredient, naloxone (76)
• 545 randomized trials and 57 systematic reviews/meta-analyses indexed in PubMed
• On the WHO Model List of Essential Medicines (shown for context; no score effect)
• 5 independent Cochrane review(s) exist
• Only 49% of completed registered trials posted results (-8)

Regulatory history: 71

• Graded by its riskiest ingredient, buprenorphine (71)
• Recalls since 2016: 0 Class I, 11 Class II, 1 Class III across 21 generic makers (-6)
• REMS program in force (-10)
• 29 label changes approved since 2021: the safety story is still moving (-8)
• Label lists recent major changes to warnings or indications (-5)

Money & lawsuits: 30

• Graded by its riskiest ingredient, buprenorphine (30)
• Pharma paid doctors $2,105,782 tied to this drug last year (-30)
• Named in 1 active federal multidistrict litigation(s) (-40)
• For the combination product itself:
• Pharma paid doctors $277,802 tied to this drug last year (-15)
• Named in 1 active federal multidistrict litigation(s) (-40)

Options: 100

• Graded by its riskiest ingredient, buprenorphine (100)
• Generic versions approved (21 applications)
• 4 same-class alternatives exist

Money and lawsuits

In 2024, drug companies reported $277,802 in payments to US physicians and hospitals tied to this combination's brands across 2,078 transactions (Suboxone $241,492, Zubsolv $36,310).

Pending federal multidistrict litigation

• MDL 3092 Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation (OHN, actions pending)

The ingredients' own payments and lawsuits are on their pages and already count toward this grade.

Who takes it and what it costs

Questions to ask your prescriber

1. This is a fixed combination of buprenorphine and naloxone. Why both together, instead of only the one I need?
2. This is a controlled substance. What is the plan for how long I take it and how I stop?
3. This drug has a REMS safety program. What monitoring does that require from us?
4. The most-reported problems in FDA's adverse event data are drug dependence, overdose, death, toxicity to various agents. How would we recognize and handle those?
5. Why this one over heroin, levomethadone, lofexidine? What would make you pick one of those instead?
6. The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?
7. This drug is in active federal litigation. What is the claim, and does it affect my risk?
8. What result are we expecting, by when, and what is the plan if it does not happen?
9. 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.)
10. In 2022 the FDA issued a safety communication about this drug (FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relie). Does that risk apply to me?
11. The most-reported problems in FDA's adverse event data are toxicity to various agents, nausea, overdose. How would we recognize and handle those?
12. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
13. Why this one over 4-dimethylaminophenol, acetylcysteine, alvimopan? What would make you pick one of those instead?