Kloxxado Side Effects

Generic name: naloxone

Medically reviewed by Drugs.com. Last updated on Sep 23, 2023.

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

Applies to naloxone: injection solution. Other dosage forms:

nasal spray

Serious side effects of Kloxxado

Along with its needed effects, naloxone (the active ingredient contained in Kloxxado) 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 Kloxxado) nasal spray.^[Ref]

Frequency not reported: Musculoskeletal pain^[Ref]