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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

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Respiratory

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).[Ref]

Respiratory side effects have rarely included with pulmonary edema.[Ref]

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.[Ref]

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.[Ref]

Gastrointestinal

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

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.[Ref]

Genitourinary

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

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).[Ref]

References

1. Shawcross DL, Jalan R "Delayed opioid withdrawal-like reaction in primary biliary cirrhosis following naloxone therapy." Gastroenterology 121 (2001): 743-4

2. Bergasa NV, Alling DW, Talbot TL, et al. "Effects of naloxone infusions in patients with the pruritus of cholestasis: a double-blind, randomized, controlled trial." Ann Intern Med 123 (1995): 161-7

3. Sanchez-Ramos JR, Senay EC "Ophthalmic naloxone elicits abstinence in opioid-dependent subjects." Br J Addict 82 (1987): 313-5

4. Burke DF, Dunwoody CJ "Naloxone: a word of caution." Orthop Nurs 9 (1990): 44-6

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

6. Lamas X, Farre M, Cami J "Acute effects of pentazocine, naloxone and morphine in opioid- dependent volunteers." J Pharmacol Exp Ther 268 (1994): 1485-92

7. Levin ER, Sharp B, Drayer JI, Weber MA "Severe hypertension induced by naloxone." Am J Med Sci 290 (1985): 70-2

8. Neal JM "Complications of naloxone." Ann Emerg Med 17 (1988): 765-6

9. Pallasch TJ, Gill CJ "Naloxone-associated morbidity and mortality." Oral Surg Oral Med Oral Pathol 52 (1981): 602-3

10. Barsan WG, Olinger CP, Adams HP Jr, Brott TG, Eberle R, Biller J, Biros M, Marler J "Use of high dose naloxone in acute stroke: possible side-effects." Crit Care Med 17 (1989): 762-7

11. Gaddis GM, Watson WA "Naloxone-associated patient violence: an overlooked toxicity?" Ann Pharmacother 26 (1992): 196-8

12. Rock P, Silverman H, Plump D, Kecala Z, Smith P, Michael JR, Summer W "Efficacy and safety of naloxone in septic shock." Crit Care Med 13 (1985): 28-33

13. Cuss FM, Colaco CB, Baron JH "Cardiac arrest after reversal of effects of opiates with naloxone." Br Med J (Clin Res Ed) 288 (1984): 363-4

14. Chamberlain JM, Klein BL "A comprehensive review of naloxane for the emergency physician." Am J Emerg Med 12 (1994): 650-60

15. Groeger JS, Inturrisi CE "High-dose naloxone: pharmacokinetics in patients in septic shock." Crit Care Med 15 (1987): 751-6

16. Harrington LW "Acute pulmonary edema following use of naloxone: a case study." Crit Care Nurse 8 (1988): 69-73

17. Wride SR, Smith RE, Courtney PG "A fatal case of pulmonary oedema in a healthy young male following naloxone administration." Anaesth Intensive Care 17 (1989): 374-7

18. Schwartz JA, Koenigsberg MD "Naloxone-induced pulmonary edema." Ann Emerg Med 16 (1987): 1294-6

19. Brimacombe J, Archdeacon J, Newell S, Martin J "Two cases of naloxone-induced pulmonary oedema--the possible use of phentolamine in management." Anaesth Intensive Care 19 (1991): 578-80

20. Flacke JW, Flacke WE, Williams GD "Acute pulmonary edema following naloxone reversal of high-dose morphine anesthesia." Anesthesiology 47 (1977): 376-8

21. Taff RH "Pulmonary edema following naloxone administration in a patient without heart disease." Anesthesiology 59 (1983): 576-7

22. Prough DS, Roy R, Bumgarner J, Shannon G "Acute pulmonary edema in healthy teenagers following conservative doses of intravenous naloxone." Anesthesiology 60 (1984): 485-6

23. Insel TR, Pickar D "Naloxone administration in obsessive-compulsive disorder: report of two cases." Am J Psychiatry 140 (1983): 1219-20

24. Voklavka J, Jacquet YF "Naloxone-induced lethargy." Arch Gen Psychiatry 38 (1981): 844-5

25. Mariani PJ "Seizure associated with low-dose naloxone." Am J Emerg Med 7 (1989): 127-9

26. Kobrinsky NL, Pruden PB, Cheang MS, Levitt M, Bishop AJ, Tenenbein M "Increased nausea and vomiting induced by naloxone in patients receiving cancer chemotherapy." Am J Pediatr Hematol Oncol 10 (1988): 206-8

27. Sandyk R, Gillman MA "Naloxone causes urinary urgency." Urology 27 (1986): 79

28. Leehey DJ, Gollapudi P, Deakin A, Reid RW "Naloxone increases water and electrolyte excretion after water loading in patients with cirrhosis and ascites." J Lab Clin med 118 (1991): 484-91

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