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Hydrostat IR Side Effects

Generic name: hydromorphone

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

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

Applies to hydromorphone: injection solution.

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Injection route (solution)

Do not confuse HYDROmorphone hydrochloride Injection [high potency formulation (HPF)] with standard parenteral formulations of Hydromorphone Hydrochloride Injection or other opioids, as overdose and death could result.HYDROmorphone hydrochloride Injection and HYDROmorphone hydrochloride Injection [high potency formulation (HPF)] exposes users to risks of addictions, abuse, and misuse, which can lead to overdose and death.

Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.Serious, life-threatening, or fatal respiratory depression may occur.

Monitor closely, especially upon initiation or following a dose increase.Prolonged use of HYDROmorphone hydrochloride Injection or HYDROmorphone hydrochloride Injection [high potency formulation (HPF)] during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.

If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Injection route (solution)

HYDROmorphone hydrochloride injection exposes users to risks of addictions, abuse, and misuse, which can lead to overdose and death.

Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.Serious, life-threatening, or fatal respiratory depression may occur.

Monitor closely, especially upon initiation or following a dose increase.Prolonged use of HYDROmorphone hydrochloride injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.

If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and 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 receiving 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.

This medicine will add to the effects of alcohol and other central nervous system (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. This effect may last for a few days after you stop using this medicine. Check with your doctor before drinking alcohol or taking any of the 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.

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 the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

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 cause serious allergic reactions, including anaphylaxis. Anaphylaxis 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 receiving this medicine.

If you have been using this medicine regularly for several weeks or longer, do not suddenly stop using it without 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.

Some babies who are born to mothers physically dependent on this medicine will also be physically dependent and may have breathing problems and withdrawal symptoms. This could be life-threatening and requires immediate medical attention. Check with your doctor right away if your baby has difficulty with breathing, shortness of breath, excessive crying, irritability, fever, vomiting, or tremors.

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 reduced 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.

Serious side effects of Hydrostat IR

Along with its needed effects, hydromorphone (the active ingredient contained in Hydrostat IR) 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 or nurse immediately if any of the following side effects occur while taking hydromorphone:

Incidence not known

  • abdominal or stomach pain
  • blurred vision
  • change in consciousness
  • change in the ability to see colors, especially blue or yellow
  • chest pain or discomfort
  • cold, clammy skin
  • confusion
  • cough
  • difficult or troubled breathing
  • dizziness
  • fast, pounding, or irregular heartbeat or pulse
  • headache
  • irregular, fast, slow, or shallow breathing
  • lightheadedness, dizziness, or fainting
  • loss of appetite
  • noisy breathing
  • pale or blue lips, fingernails, or skin
  • severe constipation
  • severe vomiting
  • slow or irregular heartbeat
  • sweating
  • tightness in the chest
  • trouble with sleeping
  • unusual tiredness
  • very slow heartbeat or pulse
  • vomiting

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

Symptoms of overdose

Other side effects of Hydrostat IR

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:

Incidence not known

  • anxiety
  • bad, unusual, or unpleasant (after) taste
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • chills
  • constricted, pinpoint, or small pupils (black part of the eye)
  • decrease in the frequency or amount of urination
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty in passing urine (dribbling)
  • double vision
  • dry mouth
  • false or unusual sense of well-being
  • fast or rapid breathing
  • feeling of warmth
  • hives or welts
  • irritability
  • itching
  • loss of appetite
  • muscle stiffness or tightness
  • nausea
  • painful urination
  • redness, pain, or swelling at the injection site
  • redness of the face, neck, arms, and occasionally, upper chest
  • relaxed or calm feeling
  • seeing, hearing, or feeling things that are not there
  • seeing double
  • shaking
  • sleepiness
  • uncontrolled eye movements
  • upper stomach pain
  • weight loss

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

Hydromorphone (the active ingredient contained in Hydrostat IR):

Opioids:

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

Does Hydrostat IR interact with my other drugs?

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Frequently asked questions

Further information

Hydrostat IR 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.