Naloxone Side Effects

It is possible that some side effects of naloxone may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to naloxone: injection solution

As well as its needed effects, naloxone may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking naloxone, check with your doctor immediately:

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 blood pressure
  • 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

General

Naloxone may precipitate withdrawal in patients receiving opioids. Withdrawal is characterized by nausea, vomiting, sweating, lacrimation, rhinorrhea, cramping, insomnia, chills/hot flashes, piloerection, tachycardia, anxiety, restlessness, irritability, tremulousness, hypertension, seizures, and cardiac arrest. Ophthalmic naloxone administration may elicit withdrawal. Similar symptoms have been noted in patients with pruritus of cholestasis who were not receiving opioids.

Withdrawal syndromes may be precipitated by as little as 0.05 to 0.2 mg intravenously in patients taking 24 mg per day of methadone.

Cardiovascular

Cardiovascular side effects have included hypotension, hypertension, atrial and ventricular tachycardia, ventricular fibrillation, left ventricular failure, and cardiac arrest. These effects occurred in postoperative patients, many of whom had cardiovascular disease.

A 45-year-old male narcotic addict and alcoholic with hepatitis and undiscovered cardiomyopathy was given 0.8 mg of naloxone intravenously over a 2 minute period and developed ventricular fibrillation. The patient required naloxone once more for this episode and again developed ventricular fibrillation. A second opiate overdose in the same patient was treated with an initial dose of 0.4 mg intravenously, followed by 0.4 mg intravenously, then intramuscularly. Each time the patient developed ventricular fibrillation responsive to cardioversion and/or lidocaine.

Severe hypertension (mean arterial pressure rising from a baseline of 107 mmHg to 147 mmHg in about 2 to 3 hours) has been reported in an essential hypertension patient given an initial 8 mg dose intravenously, followed by an infusion of 0.13 mg/min over the next 2.5 hours. When the naloxone was discontinued the blood pressure quickly returned to normal.

Mild hypotension and one case of moderate hypertension were observed in patients receiving a bolus of 4 mg/kg followed by 2 mg/kg/hour for 24 hours. One study reported that the newborn infants of mothers who have received naloxone near term may experience tachycardia.

Respiratory

Respiratory side effects have rarely included with pulmonary edema.

Pulmonary edema has occurred within 60 seconds of administration and at dosages as low as 0.1 mg in adults. Patients ranged from healthy (postoperative) to ill with conditions such as congestive heart failure and cardiopulmonary failure.

Three cases, treated with numerous drugs, developed clinical evidence of pulmonary edema shortly after intravenous administration of naloxone (0.3 to 1.6 mg).

Nervous system

A 51-year-old male was given 0.8 mg of naloxone for obtundation. Within 30 seconds of administration a grand mal seizure occurred. The patient had Pseudomonas sepsis with negative CSF cultures.

Seizures and paresthesias have been reported at both standard and high dosages.

Seizures have been reported in 5% of patients receiving a bolus of 4 mg/kg followed by 2 mg/kg/hr for 24 hours.

Nervous system side effects have included seizures, paresthesias, agitation (3%), tremors (3%), and headache (5%). Agitation, tremors, headache, alteration in mood and cognition, mental discomfort, sleepiness, and confusion have been reported rarely at high dosages. Lethargy has been reported in manic and control patients. Naloxone administration may worsen obsessive compulsive behavior.

Gastrointestinal

Gastrointestinal side effects reported in patients receiving high dose therapy have included nausea and vomiting.

Nausea and/or vomiting occurred in 32% of patients in one study who received a bolus of 4 mg/kg followed by 2 mg/kg/hr for 24 hours.

Genitourinary

Genitourinary side effects have rarely included urinary urgency. Naloxone may have a mild diuretic effect.

A 75-year-old was treated with naloxone for senile dementia. A dosage of 0.8 mg in 25 mL of normal saline was given as an infusion over 10 minutes. The treatment was given 6 times, each time the patient experienced urinary urgency (at least 5 small volume urinations over 2 hours).

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