Buprenorphine and Naloxone interaction

Buprenorphine and Naloxone: both prescribing labels flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.

Major

Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.

What the FDA labels say

From the Naloxone (ZIMHI) label · effective 2025-12-04

Major

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists : Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine, may be incomplete.

Warnings and precautionsnames BuprenorphineView label on DailyMed
Major

Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists Reversal of respiratory depression by partial agonists or mixed agonist/antagonists such as buprenorphine and pentazocine, may be incomplete.

Warnings and precautionsnames BuprenorphineView label on DailyMed
Major

Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression.

Warnings and precautionsnames BuprenorphineView label on DailyMed
Major

In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated.

Warnings and precautionsby drug classView label on DailyMed
Major

In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes.

Warnings and precautionsby drug classView label on DailyMed

From the Buprenorphine (BELBUCA) label · effective 2026-01-02

Moderate

Patient 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).

Warnings and precautionsnames NaloxoneView label on DailyMed

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Not medical advice. Interaction Checker quotes FDA label text and NIH fact sheets. Whether an interaction matters for you depends on doses, timing, kidney and liver function, and other conditions. Confirm with a pharmacist or prescriber.