Naloxone
Active ingredient · 2 therapeutic classes
Sold as Nyxoid
- Drug class
- Peripheral Opioid Receptor Antagonists
- Availability
- Prescription and OTC
- Routes
- Intramuscular, Intravenous, Subcutaneous, Nasal
- Markets covered
- 4
- Products on record
- 49
Overview
Naloxone is an active pharmaceutical ingredient in the Peripheral Opioid Receptor Antagonists group (A06AH). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 39 | May 22, 2026 |
| CA Canada | Health Canada | 5 | March 22, 2025 |
| US United States | FDA | 4 | January 14, 2026 |
| EU European Union | EMA | 1 | June 12, 2025 |
GBUnited Kingdom· MHRA
39 products
Uses
Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Oxyargin is indicated in adults.
How to take
CACanada· Health Canada
5 products
Uses
9 PART II: SCIENTIFIC INFORMATION ............................... ...... 4 mg/mL hydrochloric acid, sodium chloride, water for injection INDICATIONS AND CLINICAL USE Naloxone Injectable (Naloxone Hydrochloride Injection USP) is a pure opioid antagonist indicated for emergency use to reverse known or suspected opioid overdoses, as manifested by respiratory depression and/or severe central nervous system depression.
Naloxone Injectable can be administered by a bystander (non-health care professional) before emergency medical assistance becomes available but it is not intended to be a substitute for professional medical care. Emergency medical assistance (calling 911) should be requested immediately when an opioid overdose is suspected, before injecting Naloxone Injectable.
CONTRAINDICATIONS Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.
USUnited States· FDA
4 products
Uses
1 INDICATIONS AND USAGE Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
Naloxone HCl Nasal Spray is not a substitute for emergency medical care.
Limitations of Use:
Restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.
Naloxone HCl Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. ( 1 ) Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
EUEuropean Union· EMA
1 product
Uses
Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings. Nyxoid is indicated in adults and adolescents aged 14 years and over.
Nyxoid is not a substitute for emergency medical care.
How to take
Drug interactions
Known interactions involving Naloxone. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL045691733 · revised November 28, 2025
- [2]Health Canada (DPD) · 02458578 · revised March 22, 2025
- [3]FDA DailyMed · 0b3b5214-6f91-4b… · revised October 1, 2023 [PDF]
- [4]European Medicines Agency · EMEA/H/C/004325 · revised June 12, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.