Skip to main content

Levorphanol Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 26, 2024.

Applies to levorphanol: oral tablet.

Warning

Oral route (Tablet)

Addiction, Abuse, and Misuse

Levorphanol tartrate tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing levorphanol tartrate tablets, and monitor all patients regularly for the development of these behaviors or conditions.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant eduction programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of levorphanol tartrate tablets. Monitor for respiratory depression, especially during initiation of levorphanol tartrate tablets or following a dose increase.

Accidental Ingestion

Accidental ingestion of even one dose of levorphanol tartrate tablets, especially by children, can result in a fatal overdose of levorphanol tartrate tablets.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of levorphanol tartrate tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of levorphanol tartrate tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Serious side effects of Levorphanol

Along with its needed effects, levorphanol 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 levorphanol:

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking levorphanol:

Symptoms of overdose

Other side effects of Levorphanol

Some side effects of levorphanol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

For Healthcare Professionals

Applies to levorphanol: compounding powder, injectable solution, oral tablet.

General

The adverse effects of this drug are generally similar to the adverse effects observed with other narcotic analgesics including nausea, vomiting, altered mood and mentations, pruritus, flushing, difficulties in urination, constipation, and biliary spasm.[Ref]

Respiratory

Frequency not reported: Apnea, cyanosis, hypoventilation

Nervous system

Cases of serotonin syndrome have been reported with concomitant use of serotonergic drugs.[Ref]

Frequency not reported: Coma, convulsions, dizziness, lethargy, hypokinesia, dyskinesia, hyperkinesia, CNS stimulation

Postmarketing reports: Serotonin syndrome[Ref]

Hypersensitivity

Anaphylaxis has been reported with ingredients contained in the levorphanol tablets.

Postmarketing reports: Anaphylaxis

Cardiovascular

Frequency not reported: Cardiac arrest, shock, hypotension, arrhythmias including bradycardia and tachycardia, palpitations, extra-systoles[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting, constipation, dyspepsia, biliary tract spasm, abdominal pain, dry mouth[Ref]

Genitourinary

Frequency not reported: Urinary retention, difficulty urinating[Ref]

Dermatologic

Frequency not reported: Pruritus, urticaria, rash, sweating[Ref]

Psychiatric

Frequency not reported: Suicide attempt, depression, confusion, abnormal dreams, abnormal thinking, nervousness, drug withdrawal, personality disorder, amnesia, insomnia

Renal

Frequency not reported: Kidney failure

Endocrine

Postmarketing reports: Adrenal insufficiency, androgen deficiency

Cases of adrenal insufficiency and androgen deficiency have been reported with opioid use. Adrenal insufficiency has more often been reported following use of greater than 1 month. Androgen deficiency has occurred with chronic opioid use.

Ocular

Frequency not reported: Abnormal vision, pupillary disorder, diplopia

References

1. Multum Information Services, Inc. Expert Review Panel

2. Bellville JW, Forrest WH, Elashoff J, Laska E. Evaluating side effects of analgesics in a cooperative clinical study. Clin Pharmacol Ther. 1968;9:303-13.

3. D'Souza M. Unusual reaction to morphine. Lancet. 1987;07/11/87:98.

4. Covington EC, Gonsalves-Ebrahim L, Currie KO, et al. Severe respiratory depression from patient-controlled analgesia in renal failure. Psychosomatics. 1989;30:226-8.

5. White MJ, Berghausen EJ, Dumont SW, et al. Side effects during continuous epidural infusion of morphine and fentanyl. Can J Anaesth. 1992;39:576-82.

6. Product Information. Levo-Dromoran (levorphanol). Roche Laboratories. 2001;PROD.

7. Petersen TK, Husted SE, Rybro L, et al. Urinary retention during I.M. and extradural morphine analgesia. Br J Anaesth. 1982;54:1175-8.

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.

Medical Disclaimer