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Naloxone Side Effects

For the Consumer

Applies to naloxone: injection solution

Other dosage forms:

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

  • Abdominal or stomach cramps
  • body aches
  • convulsions
  • diarrhea
  • difficult or troubled 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
  • shivering
  • sneezing
  • sweating
  • trembling
  • weakness
  • yawning

For Healthcare Professionals

Applies to naloxone: compounding powder, 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

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]

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]

Nervous system

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]

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]

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]

References

1. "Product Information. Narcan (naloxone)." DuPont Pharmaceuticals, Wilmington, DE.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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