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What the FDA labels say about taking them together

Codeine and nalbuphine

Codeine's FDA label of December 22, 2025 names nalbuphine in its drug interactions section; nalbuphine's label does not name codeine itself but warns about its class (Opioids (opioid agonists)). The codeine label: “May reduce the analgesic effect of Codeine Sulfate Tablets and/or precipitate withdrawal symptoms.”

Check it at the source: the codeine FDA label on DailyMed (effective December 22, 2025, Hikma Pharmaceuticals USA Inc.); the nalbuphine FDA label on DailyMed (effective December 31, 2025, Hospira, Inc.).

What does the codeine label say about nalbuphine?

Codeine label, drug interactions

Clinical Impact: May reduce the analgesic effect of Codeine Sulfate Tablets and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Butorphanol, nalbuphine, pentazocine, buprenorphine.

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

What does the nalbuphine label say about codeine?

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

Nalbuphine label, warnings

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

Nalbuphine label, boxed warning

SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NALBUPHINE HYDROCHLORIDE INJECTION ‎ Addiction, Abuse, and Misuse Because the use of Nalbuphine Hydrochloride Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS ].

Source: FDA drug label (Nalbuphine Hydrochloride), Hospira, Inc., effective December 31, 2025 (SPL set 6025e8d4-5083-4c3a-58a0-050e7b0b6150), 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

1Codeine generic labelers
6Nalbuphine generic labelers
CodeineNalbuphine
Labeled forPainPain
Boxed warningYesYes
Pharmacy cost (NADAC)$0.726 per tablet 30 mg tablet$4.32 per mL 10 mg/mL ampul
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?