Note: This document contains side effect information about naloxone. Some dosage forms listed on this page may not apply to the brand name Evzio.

Applies to naloxone: injection solution. Other dosage forms:

• nasal spray

Serious side effects of Evzio

Along with its needed effects, naloxone (the active ingredient contained in Evzio) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking naloxone:

Incidence not known

• Agitation
• body aches
• chest pain
• coughing that sometimes produces a pink frothy sputum
• crying more than the usual (in babies)
• diarrhea
• difficult or trouble breathing
• excessive crying
• fast, pounding, or irregular heartbeat or pulse
• fever
• goosebumps
• increased or excessive unconscious or jerking movements
• irregular, fast or slow, or shallow breathing
• irritability
• nausea or vomiting
• nervousness
• pale or blue lips, fingernails, or skin
• restlessness
• runny nose
• seizures
• shivering
• sneezing
• sweating
• swelling in the legs and ankles
• trembling
• weakness
• yawning

For Healthcare Professionals

Applies to naloxone: compounding powder, injectable kit, injectable solution, nasal spray.

General

This drug may precipitate abrupt opioid withdrawal in physically dependent persons; signs and symptoms may include body aches, fever, sweating, sneezing, yawning, nausea, vomiting, sweating, lacrimation, rhinorrhea, cramping, insomnia, chills/hot flashes, piloerection, tachycardia, anxiety, restlessness, irritability, tremulousness, hypertension, seizures, and cardiac arrest. In the neonate, opioid withdrawal may also include convulsions, excessive crying, and hyperactive reflexes.^[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia, hypotension, hypertension

Uncommon (0.1% to 1%): Arrhythmia, bradycardia

Rare (less than 0.1%): Fibrillation, cardiac arrest

Frequency not reported: Left ventricular failure, flushing^[Ref]

In postoperative patients, many of whom had cardiovascular disease, the following cardiovascular side effects have been reported: hypotension, hypertension, atrial and ventricular tachycardia, ventricular fibrillation, left ventricular failure, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events.^[Ref]

Nervous system

Death, coma, and encephalopathy have been reported as a result of abrupt postoperative reversal of opioid depression, primarily in patients with preexisting cardiovascular disorders or in those who received other drugs with similar adverse cardiovascular effects.^[Ref]

Common (1% to 10%): Dizziness, headache

Uncommon (0.1% to 1%): Tremor

Rare (less than 0.1%): Seizures

Frequency not reported: Coma, encephalopathy, convulsions, paraesthesia, grand mal convulsion^[Ref]

Respiratory

Very rare (less than 0.01%): Pulmonary edema

Frequency not reported: Dyspnea, respiratory depression, hypoxia, nasal dryness, nasal edema, nasal congestion, nasal inflammation^[Ref]

It has been suggested that pulmonary edema may be due to a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures.

Nasal dryness, nasal edema, nasal congestion, and nasal inflammation were the most common adverse reactions reported in clinical trials with naloxone nasal spray.^[Ref]

Local

Frequency not reported: Nonspecific injection site reactions, irritation of vessel was after IV administration^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting

Uncommon (0.1% to 1%): Diarrhea, dry mouth^[Ref]

Dermatologic

Very rare (less than 0.01%): Erythema multiforme

Frequency not reported: Sweating^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Allergic reactions including urticaria, rhinitis, dyspnea, Quincke's edema, anaphylactic shock^[Ref]

Psychiatric

Frequency not reported: Agitation, hallucination, tremulousness^[Ref]

Musculoskeletal

Musculoskeletal pain was one of the more commonly reported adverse reactions in clinical trials with naloxone (the active ingredient contained in Evzio) nasal spray.^[Ref]

Frequency not reported: Musculoskeletal pain^[Ref]