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What the FDA labels say about taking them together

Buprenorphine and codeine

Codeine's FDA label of December 22, 2025 names buprenorphine in its drug interactions section; buprenorphine's label does not name codeine itself but warns about its class (Opioids (opioid agonists)). The codeine label: “MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity.”

Check it at the source: the buprenorphine FDA label on DailyMed (effective June 5, 2026); the codeine FDA label on DailyMed (effective December 22, 2025, Hikma Pharmaceuticals USA Inc.).

What does the buprenorphine label say about codeine?

Buprenorphine's label does not name codeine itself; it warns about its class (Opioids (opioid agonists)):

Buprenorphine label, warnings and precautions

Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended.

Buprenorphine label, boxed warning

Instruct patients on proper administration of BUTRANS to reduce the risk. ( 2.1 , 5.2 ) Accidental exposure to BUTRANS, especially in children, can result in fatal overdose of buprenorphine. ( 5.2 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Source: FDA drug label (Buprenorphine HCl), SpecGx LLC, effective June 5, 2026 (SPL set b60d514d-a88a-4fa2-a5b0-30ac29e04973), via openFDA; the full label on DailyMed

What does the codeine label say about buprenorphine?

Codeine label, drug interactions

Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. Examples: Phenelzine, tranylcypromine, linezolid.

Source: FDA drug label (Codeine sulfate), Hikma Pharmaceuticals USA Inc., effective December 22, 2025 (SPL set 010905f9-3bcb-4b50-9fe8-a3ad0010f14c), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

27Buprenorphine generic labelers
1Codeine generic labelers
BuprenorphineCodeine
Labeled forOpioid use disorder, PainPain
Boxed warningNoYes
Pharmacy cost (NADAC)$0.277 per tablet 2 mg tablet sl$0.726 per tablet 30 mg tablet
Shortage nowNo current entryNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?