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Hydromorphone (Dilaudid, Exalgo): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Controlled substance Schedule II Boxed warning
Strength:
2 mg, 4 mg, 8 mg, 5 mg/5 mL
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Source: FDA drug labeling via NLM DailyMed · About this document

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

Hydromorphone hydrochloride tablets and hydromorphone hydrochloride oral solution are:

  • Strong prescription pain medicines that contain 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.

Important information about hydromorphone hydrochloride:

  • Get emergency help or call 911 right away if you take too much hydromorphone hydrochloride tablets or hydromorphone hydrochloride oral solution (overdose). When you first start taking hydromorphone hydrochloride tablets or hydromorphone hydrochloride oral solution, 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. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
  • Taking hydromorphone hydrochloride tablets or hydromorphone hydrochloride oral solution with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), 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 tablets or hydromorphone hydrochloride oral solution. They could die from taking it. Selling or giving away hydromorphone hydrochloride tablets or hydromorphone hydrochloride oral solution is against the law.
  • Store hydromorphone hydrochloride tablets or hydromorphone hydrochloride oral solution 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 tablets or hydromorphone hydrochloride oral solution if you have:

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

Before taking hydromorphone hydrochloride tablets or hydromorphone hydrochloride oral solution, 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

Tell your healthcare provider if you are:

  • Noticing your pain getting worse. If your pain gets worse after you take hydromorphone hydrochloride, do not take more of hydromorphone hydrochloride without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking hydromorphone hydrochloride.
  • Pregnant or planning to become pregnant. Use of hydromorphone hydrochloride tablets and hydromorphone hydrochloride oral solution for an extended period of time 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. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.
  • 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.
  • For acute (short-term) pain, you may only need to take hydromorphone hydrochloride for a few days. You may have some hydromorphone hydrochloride left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused hydromorphone hydrochloride.
  • 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 tablets or hydromorphone hydrochloride oral solution regularly, do not stop taking hydromorphone hydrochloride tablets or hydromorphone hydrochloride oral solution without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused hydromorphone hydrochloride tablets or hydromorphone hydrochloride oral solution 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 tablets or hydromorphone hydrochloride oral solution affect 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 tablets or hydromorphone hydrochloride oral solution may cause you to overdose and die.

The possible side effects of hydromorphone hydrochloride tablets and hydromorphone hydrochloride oral solution:

  • 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 or call 911 right away if you have:

  • Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness 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 tablets and hydromorphone hydrochloride oral solution. Call your healthcare provider 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

Marketed by: Rhodes Pharmaceuticals LLC, Wilson, NC 27893 US, http://rhodespharma.com or call 1-888-873-5329.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA AUTHORIZED GENERIC 019892 · View the label on DailyMed

Revision date stated in the text: May 2026

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

Drug information for Hydromorphone

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
Dosage form Tablet, Solution
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) RHODES PHARMS
FDA approval NDA AUTHORIZED GENERIC 019892NDA authorized generic Approved December 7, 1992
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Dilaudid with the same TE code
Manufacturers 5 labelers list this drug on DailyMed
Packages (NDC)
Package
2 mg – 100 in 1 bottle, plastic NDC 42858-301-01
2 mg – 25 in 1 blister pack / 4 in 1 carton NDC 42858-301-25
4 mg – 100 in 1 bottle, plastic NDC 42858-302-01
4 mg – 25 in 1 blister pack / 4 in 1 carton NDC 42858-302-25
4 mg – 500 in 1 bottle, plastic NDC 42858-302-50
8 mg – 100 in 1 bottle, plastic NDC 42858-303-01
5 mg/5 mL – 473 ml in 1 bottle, plastic NDC 42858-304-16

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.