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Dilaudid-HP Side Effects

Generic name: hydromorphone

Medically reviewed by Drugs.com. Last updated on Oct 14, 2023.

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

Applies to hydromorphone: oral solution, oral tablet, oral tablet extended release.

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Oral route (solution; tablet)

Risk of Medication Errors. Ensure accuracy when prescribing, dispensing, and administering HYDROmorphone oral solution.

Dosing errors due to confusion between mg and mL can result in accidental overdose and death.Addiction, Abuse, and MisuseHYDROmorphone exposes 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 HYDROmorphone, and monitor all patients regularly for the development of these behaviors and 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 education 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 HYDROmorphone.

Monitor for respiratory depression, especially during initiation of HYDROmorphone or following a dose increase.Accidental Ingestion. Accidental ingestion of even one dose of HYDROmorphone, especially by children, can result in a fatal overdose of HYDROmorphone.Neonatal Opioid Withdrawal Syndrome. Prolonged use of HYDROmorphone 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 HYDROmorphone 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.

Oral route (tablet, extended release)

Addiction, Abuse, and MisuseHYDROmorphone hydrochloride exposes 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 HYDROmorphone hydrochloride, and monitor all patients regularly for the development of these behaviors and 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 education 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 HYDROmorphone hydrochloride.

Monitor for respiratory depression, especially during initiation of HYDROmorphone hydrochloride or following a dose increase.

Instruct patients to swallow HYDROmorphone hydrochloride extended-release tablets whole; crushing, chewing, or dissolving HYDROmorphone hydrochloride can cause rapid release and absorption of a potentially fatal dose of HYDROmorphone.Accidental Ingestion. Accidental ingestion of even one dose of HYDROmorphone hydrochloride, especially by children, can result in a fatal overdose of HYDROmorphone.Neonatal Opioid Withdrawal Syndrome. Prolonged use of HYDROmorphone hydrochloride 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 HYDROmorphone 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. 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.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). 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 hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the other medicines listed above 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.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

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.

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.

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.

This medicine may cause serious allergic reactions, including 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.

If you have been using this medicine regularly for several weeks or more, do not change your dose or suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely, or to take another narcotic for a while, to lessen the chance of withdrawal side effects (eg, anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping).

Using too much hydromorphone (the active ingredient contained in Dilaudid-HP) may cause an overdose, which can be life-threatening. Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. . In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

For nursing mothers taking this medicine:

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 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.

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.

Common side effects of Dilaudid-HP

Some side effects of hydromorphone 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:

More common side effects

  • difficulty having a bowel movement
  • difficulty with moving
  • joint pain
  • muscle pain or stiffness

Less common side effects

  • back pain
  • belching
  • diarrhea
  • discouragement
  • feeling sad or empty
  • heartburn
  • indigestion
  • irritability
  • loss of interest or pleasure
  • muscle spasms
  • pain in the arms or legs
  • stomach discomfort, upset, or pain
  • tingling of the hands or feet
  • trouble concentrating
  • unusual weight gain or loss
  • being forgetful
  • bleeding after defecation
  • clumsiness
  • continuing ringing or buzzing or other unexplained noise in the ears
  • crying
  • delusions of persecution, mistrust, suspiciousness, or combativeness
  • difficulty with swallowing
  • difficulty with walking
  • double vision
  • excess air or gas in the stomach or bowels
  • feeling of constant movement of self or surroundings
  • full feeling
  • increased appetite
  • joint pain, stiffness, or swelling
  • loss in sexual ability, desire, drive, or performance
  • loss of balance
  • low body temperature
  • muscle aches
  • muscle twitching or jerking
  • rhythmic movement of muscles
  • runny nose
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • shivering
  • slurred speech
  • sneezing
  • trouble with speaking

Incidence not known

  • bad, unusual or unpleasant (after) taste
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chills
  • drowsiness
  • dry mouth
  • false or unusual sense of well-being
  • fear or nervousness
  • feeling of warmth
  • muscle stiffness or tightness
  • numbness of the feet, hands, and around the mouth
  • redness of the face, neck, arms, and occasionally, upper chest
  • relaxed and calm feeling
  • shaking
  • uncontrolled eye movements
  • upper stomach pain

Serious side effects of Dilaudid-HP

Along with its needed effects, hydromorphone 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 hydromorphone:

Less common side effects

  • agitation
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody, black, or tarry stools
  • blurred vision
  • changes in behavior
  • chest pain or discomfort
  • decreased urination
  • dry mouth
  • fast, pounding, slow, or irregular heartbeat
  • lightheadedness, dizziness, or fainting
  • mood or mental changes
  • rapid breathing
  • severe stomach pain, cramping, or burning
  • stiff neck
  • sunken eyes
  • thoughts of killing oneself
  • trouble breathing
  • unusual tiredness or weakness
  • vomiting of material that looks like coffee grounds, severe and continuing
  • wrinkled skin

Incidence not known

  • bluish lips or skin
  • change in the ability to see colors, especially blue or yellow
  • cold, clammy skin
  • confusion
  • constricted, pinpoint, or small pupils (black part of the eye)
  • cough
  • darkening of the skin
  • decrease in frequency of urination or urine amount
  • deep or fast breathing with dizziness
  • difficulty in passing urine (dribbling)
  • fast or weak pulse
  • headache
  • hives or welts, itching, skin rash
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • mental depression
  • nausea
  • noisy breathing
  • overactive reflexes
  • painful urination
  • pale or blue lips, fingernails, or skin
  • poor coordination
  • restlessness
  • sweating
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • trouble sleeping
  • vomiting

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

Symptoms of overdose

For healthcare professionals

Applies to hydromorphone: compounding powder, injectable powder for injection, injectable solution, intravenous solution, oral capsule extended release, oral liquid, oral tablet, oral tablet extended release, rectal suppository.

General adverse events

The most common adverse effects are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.[Ref]

Gastrointestinal

Nervous system

Psychiatric

Hypersensitivity

Respiratory

Cardiovascular

Dermatologic

Local

Genitourinary

Hepatic

Other

Metabolic

Musculoskeletal

Ocular

Renal

Endocrine

Opioids:

Hydromorphone (the active ingredient contained in Dilaudid-HP)

See also:

References

1. (2001) "Product Information. Dilaudid (hydromorphone)." Knoll Pharmaceutical Company

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

3. Cerner Multum, Inc. "UK Summary of Product Characteristics."

4. Cerner Multum, Inc. "Australian Product Information."

5. (2010) "Product Information. Exalgo (hydromorphone)." Covidien

Frequently asked questions

Further information

Dilaudid-HP 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.