Applies to naloxone: injection solution. Other dosage forms:
- nasal spray
Serious side effects of Naloxone
Along with its needed effects, naloxone 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 nasal spray.[Ref]
Frequency not reported: Musculoskeletal pain[Ref]
