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Note: This document contains side effect information about naloxone. Some of the dosage forms listed on this page may not apply to the brand name Evzio.
Applies to naloxone: injection solution
Other dosage forms:
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
Applies to naloxone: compounding powder, injectable solution, nasal spray
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.
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.
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
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
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.
Very rare (less than 0.01%): Pulmonary edema
Frequency not reported: Dyspnea, respiratory depression, hypoxia, nasal dryness, nasal edema, nasal congestion, nasal inflammation
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.
Frequency not reported: Nonspecific injection site reactions, irritation of vessel was after IV administration
Common (1% to 10%): Nausea, vomiting
Uncommon (0.1% to 1%): Diarrhea, dry mouth
Very rare (less than 0.01%): Erythema multiforme
Frequency not reported: Sweating
Very rare (less than 0.01%): Allergic reactions including urticaria, rhinitis, dyspnea, Quincke's edema, anaphylactic shock
Frequency not reported: Agitation, hallucination, tremulousness
Musculoskeletal pain was one of the more commonly reported adverse reactions in clinical trials with naloxone (the active ingredient contained in Evzio) nasal spray.
Frequency not reported: Musculoskeletal pain
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