Skip to main content

Levo-Dromoran Side Effects

Generic name: levorphanol

Medically reviewed by Drugs.com. Last updated on Nov 13, 2024.

Note: This document provides detailed information about Levo-Dromoran Side Effects associated with levorphanol. Some dosage forms listed on this page may not apply specifically to the brand name Levo-Dromoran.

Applies to levorphanol: oral tablet.

Important warnings This medicine can cause some serious health issues

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.

Precautions

It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Levo-Dromoran

Along with its needed effects, levorphanol (the active ingredient contained in Levo-Dromoran) 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

  • agitation
  • attempts at killing oneself
  • bluish lips or skin
  • blurred vision
  • change in consciousness
  • cold, clammy skin
  • confusion
  • darkening of the skin
  • decrease in the frequency of urination
  • decreased awareness or responsiveness
  • decreased urine output
  • depression
  • diarrhea
  • difficulty in passing urine (dribbling)
  • difficulty swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • extra heartbeat
  • extremely shallow or slow breathing
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • fast, weak pulse
  • fever
  • hostility
  • hives or welts, itching, skin rash
  • lightheadedness
  • loss of appetite
  • loss of consciousness
  • muscle twitching
  • nausea
  • no blood pressure or pulse
  • not breathing
  • overactive reflexes
  • painful urination
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • restlessness
  • seizures
  • severe sleepiness
  • shivering
  • stopping of the heart
  • sweating
  • swelling of the face, ankles, or hands
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • trembling or shaking
  • twitching
  • unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
  • vomiting

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

Symptoms of overdose

Other side effects of Levo-Dromoran

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

  • abnormal dreams
  • absence of or decrease in body movement
  • belching
  • change in personality
  • changes in vision
  • discouragement
  • double vision
  • dry mouth
  • false beliefs that cannot be changed by facts
  • feeling sad or empty
  • heartburn
  • increase in body movements
  • indigestion
  • irritability
  • loss of interest or pleasure
  • loss of memory
  • nervousness
  • poor insight and judgment
  • problems with memory or speech
  • redness of the skin
  • seeing double
  • stomach discomfort, upset, or pain
  • sweating
  • trouble concentrating
  • trouble recognizing objects
  • trouble sleeping
  • trouble thinking and planning
  • trouble walking
  • twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  • upper abdominal or stomach pain

For healthcare professionals

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

General adverse events

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

Nervous system

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

Hypersensitivity

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

Cardiovascular

Gastrointestinal

Genitourinary

Dermatologic

Psychiatric

Renal

Endocrine

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

See also:

References

1. "Multum Information Services, Inc. Expert Review Panel"

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

3. D'Souza M (1987) "Unusual reaction to morphine." Lancet, 07/11/87, p. 98

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

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

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

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

Further information

Levo-Dromoran side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.