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
Plain-language summary, compiled from the cited regulatory records
Naloxone is a medication classified as a peripheral opioid receptor antagonist [1]. It is approved for the emergency treatment of known or suspected opioid overdose [1]. This condition is typically identified by respiratory and/or central nervous system depression [1]. Naloxone is intended for immediate use in situations where opioids might be present, serving as an emergency therapy [1]. It is important to note that naloxone is not a replacement for professional medical care [1].
Naloxone is available under various brand names.
This is not medical advice. Consult a qualified healthcare professional.
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. Sofonac 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
Indications and Usage Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine.
Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; ADJUNCTIVE USE IN SEPTIC SHOCK).
How to take
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) · PL215970086 · revised May 15, 2026
- [2]Health Canada (DPD) · 02458578 · revised March 22, 2025
- [3]FDA DailyMed · 10c22ce2-7dbe-44… · revised September 5, 2025 [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.