What the FDA labels say about taking them together
Buprenorphine and naloxone
Buprenorphine's FDA label of June 5, 2026 names naloxone in its drug interactions section, and naloxone's label names buprenorphine too. The buprenorphine label: “Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death.”
Check it at the source: the buprenorphine FDA label on DailyMed (effective June 5, 2026); the naloxone FDA label on DailyMed (effective August 17, 2026, Emergent Devices Inc.).
What does the buprenorphine label say about naloxone?
Buprenorphine label, drug interactionsBenzodiazepines or Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. … treatments [see Warnings and Precautions (,)]. If concomitant use is warranted, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, as is recommended for all patients in treatment for opioid use disorder [see Warnings and Precautions ()]. …
Buprenorphine label, warnings and precautionsBecause patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with buprenorphine sublingual tablets.
Brixadi label (Braeburn Inc., December 31, 2025), warnings and precautionsAdvise patients and caregivers that an opioid overdose reversal agent, such as naloxone or nalmefene, may also be administered for a known or suspected overdose with buprenorphine itself.
Butrans label (Knoa Pharma LLC, May 1, 2026), warnings and precautionsPatient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene).
Source: FDA drug label (Brixadi, NDA210136), Braeburn Inc., effective December 31, 2025 (SPL set 5d8a8fd0-8619-422a-a664-d1d2e8970f48), via openFDA
Source: FDA drug label (Butrans, NDA021306), Knoa Pharma LLC, effective May 1, 2026 (SPL set 794aa355-66de-41b8-aedf-f2c40f6bc664), via openFDA
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 naloxone label say about buprenorphine?
Zimhi label (ZMI Pharma Inc., December 4, 2025), warnings and precautionsReversal of respiratory depression caused by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine, may be incomplete.
Source: FDA drug label (Zimhi, NDA212854), ZMI Pharma Inc., effective December 4, 2025 (SPL set 523c0909-bff6-4010-988a-53de18b7cb3f), via openFDA
Source: FDA drug label (NARCAN), Emergent Devices Inc., effective August 17, 2026 (SPL set a0ebc83d-2892-40de-bc0a-775ce90b30db), 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
| Buprenorphine | Naloxone | |
|---|---|---|
| Labeled for | Opioid use disorder, Pain | n/a |
| Boxed warning | No | No |
| Pharmacy cost (NADAC) | $0.277 per tablet 2 mg tablet sl | $12.74 per mL 2 mg/2 mL syringe |
| Shortage now | No current entry | No 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?
- Check more medicines together
- up to five at once