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Hydromorphone Hydrochloride Rectal: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Controlled substance Schedule II Boxed warning Being discontinued since July 23, 2026
Strength:
3 mg
Brand names:
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Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Hydromorphone Hydrochloride Rectal

Hydromorphone hydrochloride suppositories are:

  • Strong prescription pain medicines that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid analgesic, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • Opioid pain medicines that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Opioid pain medicines that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about hydromorphone hydrochloride suppositories:

  • Get emergency help or call 911 right away if you take too much hydromorphone hydrochloride suppositories (overdose).When you first start taking hydromorphone hydrochloride suppositories, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your doctor about naloxone, a medicine for the emergency treatment of an opioid overdose.
  • Taking hydromorphone hydrochloride suppositories with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your hydromorphone hydrochloride suppositories. They could die from taking it. Selling or giving away hydromorphone hydrochloride suppositories is against the law.
  • Store hydromorphone hydrochloride suppositories securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Taking hydromorphone hydrochloride suppositories with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Never give anyone else your hydromorphone hydrochloride suppositories. They could die from taking it. Selling or giving away hydromorphone hydrochloride suppositories is against the law.

Store hydromorphone hydrochloride suppositories securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take hydromorphone hydrochloride suppositories if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

a bowel blockage or have narrowing of the stomach or intestines.

Before taking hydromorphone hydrochloride suppositories, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • problems urinating
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

problems urinating

liver, kidney, thyroid problems

pancreas or gallbladder problems

abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

  • Pregnant or planning to become pregnant. Prolonged use of hydromorphone hydrochloride suppositories during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • Breastfeeding. Hydromorphone hydrochloride passes into breast milk and may harm your baby.
  • Living in a household where there are small children or someone who has abused street or prescription drugs.
  • Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking hydromorphone hydrochloride with certain other medicines can cause serious side effects that could lead to death.

Breastfeeding. Hydromorphone hydrochloride passes into breast milk and may harm your baby.

Living in a household where there are small children or someone who has abused street or prescription drugs.

Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking hydromorphone hydrochloride with certain other medicines can cause serious side effects that could lead to death.

When taking hydromorphone hydrochloride:

  • Do not change your dose. Take hydromorphone hydrochloride exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking hydromorphone hydrochloride suppositories regularly, do not stop taking hydromorphone hydrochloride suppositories without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused hydromorphone hydrochloride suppositories by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.

Call your healthcare provider if the dose you are taking does not control your pain.

If you have been taking hydromorphone hydrochloride suppositories regularly, do not stop taking hydromorphone hydrochloride suppositories without talking to your healthcare provider.

Dispose of expired, unwanted, or unused hydromorphone hydrochloride suppositories by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking hydromorphone hydrochloride DO NOT:

  • Drive or operate heavy machinery, until you know how hydromorphone hydrochloride suppositories affects you. Hydromorphone hydrochloride can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with hydromorphone hydrochloride suppositories may cause you to overdose and die.

Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with hydromorphone hydrochloride suppositories may cause you to overdose and die.

The possible side effects of hydromorphone hydrochloride suppositories:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, lightheadedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of hydromorphone hydrochloride suppositories. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Manufactured by Padagis®, Minneapolis, MN 55427

www.padagis.com or call 1-866-634-9120

Issued: 09/2023

7C000 RC MG1

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Revision date stated in the text: September 2023

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Hydromorphone Hydrochloride Rectal

Rx or OTC
Prescription (Rx), Controlled substance?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • This drug is a controlled substance under the federal Controlled Substances Act.
  • Rx
Controlled substance Schedule IISchedule II: high potential for abuse; abuse may lead to severe psychological or physical dependence.
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Opioid Agonist
Active ingredient Hydromorphone hydrochloride 3 mg
Dosage form Suppository
Route Rectal
Marketing status listed in the FDA NDC Directory
Company (applicant) Padagis US LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Drug shortage
  • Being discontinued since July 23, 2026
Packages (NDC)
Package
3 mg – 1 in 1 packet / 6 in 1 box NDC 0574-7224-06

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.