bupropion / dextromethorphan

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 (56/100)

Safety: 52

• Graded by its riskiest ingredient, bupropion (52)
• Carries an FDA boxed warning, the strongest warning the FDA issues (-30)
• FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-8)
• Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)
• 2,223 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site
• Death share in reports is near or below the FAERS average (1.1x)

Evidence: 46

• Graded by its riskiest ingredient, dextromethorphan (46)
• 157 randomized trials and 10 systematic reviews/meta-analyses indexed in PubMed
• No Cochrane review found (-5)
• Only 39% of completed registered trials posted results (-8)
• 'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)

Regulatory history: 81

• Graded by its riskiest ingredient, bupropion (81)
• Recalls since 2016: 0 Class I, 3 Class II, 10 Class III across 64 generic makers (-6)
• 18 label changes approved since 2021: the safety story is still moving (-8)
• Label lists recent major changes to warnings or indications (-5)

Money & lawsuits: 50

• Graded by its riskiest ingredient, bupropion (50)
• Maker paid $3 billion ($1B criminal, $2B civil) in 2012 to settle federal allegations naming this drug (Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to) (-35)
• Pharma paid doctors $219,060 tied to this drug last year (-15)
• Not named in any pending federal MDL
• For the combination product itself:
• Pharma paid doctors $10,572,738 tied to this drug last year (-45)
• Not named in any pending federal MDL

Options: 70

• Graded by its riskiest ingredient, bupropion (70)
• Generic versions approved (64 applications)
• No same-class alternatives found: little leverage to switch (-30)

Money and lawsuits

In 2024, drug companies reported $10,572,738 in payments to US physicians and hospitals tied to this combination's brands across 66,567 transactions (Auvelity $10,572,738).

No pending federal MDL names this combination or its brands.

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

Who takes it and what it costs

Not in the Medicare Part D spending file.

Questions to ask your prescriber

1. This is a fixed combination of bupropion and dextromethorphan. Why both together, instead of only the one I need?
2. In 2016 the FDA issued a safety communication about this drug (FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and ). Does that risk apply to me?
3. An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?
4. The maker paid $3 billion in 2012 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?
5. This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
6. The most-reported problems in FDA's adverse event data are fatigue, nausea, headache. How would we recognize and handle those?
7. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
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. The most-reported problems in FDA's adverse event data are toxicity to various agents, drug abuse, diarrhoea. How would we recognize and handle those?
11. Why this one over codeine, ethylmorphine, hydrocodone? What would make you pick one of those instead?