Naloxone/Pentazocine Side Effects

Please note - some side effects for Naloxone/Pentazocine 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/Pentazocine - for the Consumer

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.

Side Effects by Body System

Cardiovascular

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 of naloxone 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 dose of 4 mg/kg of naloxone 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.

Cardiovascular side effects with the use of naloxone have included hypotension, hypertension, atrial and ventricular tachycardia, ventricular fibrillation, left ventricular failure and cardiac arrest (mostly in postoperative patients, many of whom had cardiovascular disease).

Cardiovascular side effects including a decrease in blood pressure and tachycardia have been reported infrequently with the use of pentazocine.

Other

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

Other side effect including withdrawal in patients receiving opiates have been precipitated by naloxone. 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. Similar symptoms have been noted in patients with pruritus of cholestasis who were not receiving opiates.

Other side effects including tinnitus have been reported with the use of pentazocine.

Respiratory

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

Respiratory side effects including pulmonary edema have been uncommon from the use of naloxone.

Respiratory side effects including respiratory depression have rarely been reported with the use of pentazocine.

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.

Nervous system side effects including seizures and paresthesias have been reported at both standard and high dosages of naloxone. Seizures have been reported in 5% of patients receiving a bolus of 4 mg/kg followed by 2 mg/kg/h for 24 hours. Agitation has been noted in 3%, tremors in 3%, and headache in 5%. Rarely, agitation, tremors, headache, alteration in mood and cognition, mental discomfort, sleepiness, and confusion have been reported at high dosages. Lethargy has been reported in manic and control patients. Naloxone administration may worsen obsessive compulsive behavior.

Nervous system side effects including sweating, dizziness, lightheadedness, hallucinations, sedation, euphoria, headache, confusion, and disorientation have been reported with the use of pentazocine. Weakness, flushing, disturbed dreams, insomnia, and syncope have been reported infrequently. Tremor, chills, paresthesia, irritability, and excitement have been reported rarely.

Gastrointestinal

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

Gastrointestinal side effects of nausea and vomiting have been reported in patients receiving high dose naloxone therapy.

Gastrointestinal side effects including nausea and vomiting have been reported with the use of pentazocine. Constipation has been reported infrequently. Abdominal distress, anorexia, and diarrhea have been reported rarely.

Genitourinary

Genitourinary side effects including an increase in urinary urgency have rarely been reported with the use of naloxone. The drug may also have a mild diuretic effect.

Genitourinary side effects including urinary retention have rarely been reported with the use of pentazocine.

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).

Hematologic

Depression of the white blood cell count is usually reversible.

Hematologic side effects including depression of the white blood cell count (especially granulocytes) and moderate transient eosinophilia have been reported with the use of pentazocine.

Hypersensitivity

Hypersensitivity reactions including rash have been reported infrequently. Urticaria and edema of the face have been reported rarely with the use of pentazocine. One instance of an apparent anaphylactic reaction has been reported.

Dermatologic

Dermatologic side effects including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely with the use of pentazocine.

Ocular

Ocular side effects including visual blurring and focusing difficulty have been reported infrequently with the use of pentazocine.

Psychiatric

Psychiatric side effects including depression have been reported infrequently with the use of pentazocine.

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