Naloxone Side Effects

Brand Names: Narcan

Please note - some side effects for Naloxone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Naloxone - for the Consumer

Naloxone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Naloxone:

Change in mood; increased sweating; nausea; nervousness; restlessness; trembling; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dizziness; fainting; fast or irregular pulse; flushing; headache; heart rhythm changes; seizures; sudden chest pain.

Naloxone/Pentazocine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Naloxone/Pentazocine:

Constipation; diarrhea; dizziness; drowsiness; flushing; headache; loss of appetite; nausea; sleeplessness; sweating; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety or nervousness; blurred vision or difficulty focusing your eyes; confusion; decreased urination; disorientation; fainting; fast heartbeat; fever, chills, or persistent sore throat; hallucination; mental or mood changes (eg, depression); red, swollen, blistered, or peeling skin; seizures; slow or shallow breathing.

Naloxone Side Effects - for the Professional

Naloxone

Abrupt reversal of narcotic depression may result in nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures and cardiac arrest. In postoperative patients, Iarger than necessary dosages of Naloxone hydrochloride may result in significant reversal of analgesia, and in excitement. Hypotension, hypertension, ventricular tachycardia and fibrillation, and pulmonary edema have been associated with the use of Naloxone postoperatively.

Naloxone Injection

Postoperative

The following adverse events have been associated with the use of Naloxone hydrochloride injection in postoperative patients: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of Naloxone in postoperative patients may result in significant reversal of analgesia and may cause agitation.

Opioid Depression

Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest which may result in death.

Opioid Dependence

Abrupt reversal of opioid effects in persons who are physically dependent on opioids may precipitate an acute withdrawal syndrome which may include, but not limited to the following signs and symptoms: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In the neonate, opioid withdrawal may also include: convulsions, excessive crying, and hyperactive reflexes.

Adverse events associated with the postoperative use of Naloxone hydrochloride injection are listed by organ system and in decreasing order of frequency as follows:

Cardiac Disorders: pulmonary edema, cardiac arrest or failure, tachycardia, ventricular fibrillation, and ventricular tachycardia. Death, coma, and encephalopathy have been reported as sequelae of these events.

Gastrointestinal Disorders: vomiting, nausea

Nervous System Disorders: convulsions, paraesthesia, grand mal convulsion

Psychiatric Disorders: agitation, hallucination, tremulousness

Respiratory, Thoracic, and Mediastinal Disorders: dyspnea, respiratory depression, hypoxia

Skin and Subcutaneous Tissue Disorders: nonspecific injection site reactions, sweating

Vascular Disorders: hypertension, hypotension, hot flashes, or flushing

See also PRECAUTIONS and DOSAGE AND ADMINISTRATION; Usage in Adults, Postoperative Opioid Depression

Side Effects by Body System

General

Naloxone may precipitate withdrawal in patients receiving opiates. 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 opiates.

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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