celecoxib / tramadol

What is in it

Ingredients with a page of their own link to it: the FDA label, side-effect reports, recalls, evidence, and payments behind this grade are there.

Score breakdown (60/100)

Safety: 34

• Graded by its riskiest ingredient, tramadol (34)
• Carries an FDA boxed warning, the strongest warning the FDA issues (-30)
• FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2017 (-16)
• 1,702 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site
• Subject to a REMS safety program: FDA requires special controls to use it (-10)
• Federally controlled substance: dependence and misuse risk (-10)
• Death share in reports is near or below the FAERS average (1.4x)

Evidence: 60

• Graded by its riskiest ingredient, celecoxib (60)
• 466 randomized trials and 56 systematic reviews/meta-analyses indexed in PubMed
• Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)
• 8 independent Cochrane review(s) exist
• Only 41% of completed registered trials posted results (-8)
• 'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)

Regulatory history: 76

• Graded by its riskiest ingredient, tramadol (76)
• Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 35 generic makers (-1)
• REMS program in force (-10)
• 10 label changes approved since 2021: the safety story is still moving (-8)
• Label lists recent major changes to warnings or indications (-5)

Money & lawsuits: 100

• Graded by its riskiest ingredient, celecoxib (100)
• Pharma paid doctors $0 tied to this drug last year: negligible
• Not named in any pending federal MDL

Options: 70

• Graded by its riskiest ingredient, tramadol (70)
• Generic versions approved (35 applications)
• No same-class alternatives found: little leverage to switch (-30)

Money and lawsuits

In 2024, drug companies reported $2,271 in payments to US physicians and hospitals tied to this combination's brands across 3 transactions (Seglentis $2,271).

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

Questions to ask your prescriber

1. This is a fixed combination of celecoxib and tramadol. Why both together, instead of only the one I need?
2. 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?
3. This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
4. The most-reported problems in FDA's adverse event data are pain, arthralgia, fatigue. How would we recognize and handle those?
5. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
6. Why this one over etoricoxib, parecoxib, rofecoxib? What would make you pick one of those instead?
7. What result are we expecting, by when, and what is the plan if it does not happen?
8. 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.)
9. In 2017 the FDA issued a safety communication about this drug (FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children…). Does that risk apply to me?
10. This is a controlled substance. What is the plan for how long I take it and how I stop?
11. This drug has a REMS safety program. What monitoring does that require from us?
12. The most-reported problems in FDA's adverse event data are drug dependence, pain, overdose, nausea. How would we recognize and handle those?