Skip to the answer

Hydromorphone

Hydromorphone is a strong opioid pain medicine used for pain severe enough to need an opioid when other treatments aren't enough, and it comes as tablets, oral solution, extended-release tablets, injection and rectal suppositories.

Brand names DilaudidExalgo
Drug classes Full Opioid Agonists
Rx Schedule CII Forms 5
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 20 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

Other forms & routes:
Injection Rectal
Hydromorphone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Hydromorphone (Dilaudid) is a strong opioid for severe pain when other treatments fall short, acting on opioid receptors in the brain and spinal cord, and it is a well-known older standby, on the U.S. market since about 1972 and available generically. Most people notice constipation that rarely eases with time, plus nausea, sleepiness, dizziness or itching, especially early on. Its boxed warning covers addiction, overdose and life-threatening slowed breathing, most likely when starting or raising the dose and far more likely with alcohol or sedating drugs, so avoid those and take it exactly as prescribed. Lock it away, since one dose can kill a child.

Clinical pearls

  • Measure the oral solution with a proper dosing syringe, never a kitchen spoon, and confirm whether the dose is in mg or mL.
  • Gabapentin, pregabalin, sleep aids and muscle relaxants all stack with hydromorphone to slow breathing, so list every one for your prescriber.
  • Ask for naloxone, an overdose reversal medicine, and show someone at home where it is kept.
  • Extended-release tablets are only for people already used to daily opioids, never for as-needed pain.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Hydromorphone can cause addiction, life-threatening slowed breathing, and fatal overdose. Here is what the warning means:

  • Dosing mix-ups: With the oral solution, confusing mg and mL, or different strengths, can cause accidental overdose and death.
  • Addiction and misuse: This can happen even when taken as prescribed. Your prescriber should check your risk and reassess regularly.
  • Slowed breathing: The risk is highest when starting or raising the dose.
  • Accidental ingestion: Even one dose of the tablets or oral solution can be fatal, especially for children.
  • Sedating medicines and alcohol: Combining with benzodiazepines, alcohol or other sedating drugs can cause deep sedation, coma and death.
  • Pregnancy: Long-term use can cause life-threatening withdrawal in newborns.

Read the Medication Guide with each prescription.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asInjection, Tablet, Extended-release tablet +2
Earliest FDA record1972
Companies listing it with the FDA17
FDA label last updatedMay 14, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Hydromorphone, written from its FDA label.

What Hydromorphone is used for

▾

Hydromorphone is an opioid pain medicine with several forms.

  • Pain severe enough to need an opioid when other treatments are inadequate: tablets, oral solution, injection and rectal suppositories, including Dilaudid tablets, oral solution and injection.
  • Severe, persistent pain needing daily, long-term treatment: hydromorphone hydrochloride extended-release tablets, for opioid-tolerant patients only.
  • Hydromorphone injection high potency formulation (HPF): only for opioid-tolerant patients needing higher doses.

How Hydromorphone works

▾

Hydromorphone is a full opioid agonist that mainly binds to mu-opioid receptors in the brain and spinal cord. These receptors help control how pain is felt. Its main benefit is pain relief, and there is no ceiling to its pain-relieving effect. Doses are adjusted to balance pain relief against side effects like slowed breathing and sedation.

Hydromorphone dosage

▾

Dosing depends on the product and your needs. Your prescriber should use the lowest effective dose for the shortest time.

  • Tablets and oral solution are taken by mouth.
  • Extended-release tablets are taken by mouth, with or without food, for around-the-clock pain.
  • Injections are given into a vein, muscle or under the skin.
  • Suppositories are used rectally.

Follow your prescriber and the label exactly.

Dosing details from the FDA-approved label

From the Hydromorphone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Hydromorphone hydrochloride oral solution (initial treatment for pain)
    • Initiate in a dosing range of 2.5 mL to 10 mL, 2.5 mg to 10 mg, every 3 to 6 hours as needed for pain, at the lowest dose necessary to achieve adequate analgesia
    • Titrate based upon the individual patient's response to the initial dose
  • Hydromorphone hydrochloride tablets (initial treatment for pain)
    • Initiate in a dosing range of 2 mg to 4 mg, orally, every 4 to 6 hours as needed for pain, at the lowest dose necessary to achieve adequate analgesia
    • Titrate based upon the individual patient's response to the initial dose
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Hydromorphone hydrochloride extended-release tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) • Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of hydromorphone hydrochloride extended-release tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) • Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse ( 2.1 , 5.1 ) • Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with hydromorphone hydrochloride extended-release tablets. Consider this risk when selecting an initial dose and when making dose adjustments ( 2.1 , 5.2 ) • For once daily administration IN OPIOID-TOLERANT PATIENTS. ( 2.1 ) • Instruct patients to swallow hydromorphone hydrochloride extended-release tablets intact, and not to cut, break, chew, crush, or dissolve the tablets (risk of potentially fatal overdose). ( 2.1 , 5.1 ) • Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with hydromorphone hydrochloride extended-release tablets, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose. ( 2.2 , 5.1 , 5.2 , 5.3 ) • Dose may be increased using increments of 4 to 8 mg every 3 to 4 days as needed to achieve adequate analgesia. ( 2.4 ) • Periodically reassess patients receiving hydromorphone hydrochloride extended-release tablets to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Hydromorphone side effects

▾

Common side effects include:

Common side effects

  • Constipation
  • Nausea
  • Vomiting
  • Sleepiness (somnolence)
  • Headache
  • Dizziness
  • Itching
  • Tiredness or weakness

When to get medical help

  • Slow, shallow or troubled breathing, or extreme sleepiness, can be life-threatening. Call 911 or get emergency help right away.
  • Suspected overdose, including pinpoint pupils, cold clammy skin, or being unable to wake up, needs emergency help immediately.
  • Signs of addiction, abuse or misuse, such as using it in ways not prescribed. Tell your prescriber.
  • Signs of serotonin syndrome if you also take serotonin-affecting medicines. Call your doctor right away.
  • Severe dizziness, fainting or low blood pressure.
  • Pain that gets worse or becomes more sensitive while on the medicine (opioid-induced hyperalgesia).
  • Signs of low adrenal function, such as ongoing nausea, weakness or fatigue.
  • Allergic reaction such as swelling, trouble breathing or severe rash (anaphylaxis).

Hydromorphone warnings and precautions

▾
  • Addiction, abuse and misuse can happen even at prescribed doses.
  • Slowed breathing can be fatal, especially when starting or raising the dose, and in older, frail, or lung-disease patients.
  • Accidental ingestion, especially by children, can be fatal.
  • Oral solution dosing errors (mg versus mL) can cause overdose.
  • Sedating medicines and alcohol raise the risk of coma and death.
  • Newborn withdrawal can occur with long-term use in pregnancy.
  • Other risks include low blood pressure, adrenal problems, worsening pain sensitivity, and seizures.

Hydromorphone interactions

▾

Several medicines can interact with hydromorphone.

  • Benzodiazepines, sedatives, muscle relaxants, gabapentin, pregabalin, and other opioids: deep sedation and slowed breathing.
  • Alcohol and illicit drugs: same risks.
  • MAO inhibitors: avoid during and within 14 days of stopping.
  • Serotonin-affecting medicines: risk of serotonin syndrome.
  • Buprenorphine, butorphanol, nalbuphine, pentazocine: may reduce pain relief or trigger withdrawal.
  • Diuretics: may be less effective.
  • Anticholinergics: urinary retention and severe constipation.

Interactions listed in the FDA-approved label

From the Hydromorphone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Benzodiazepines and other CNS depressants (including alcohol, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids, other opioids): Additive pharmacologic effect can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Reserve concomitant prescribing for patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; inform patients and caregivers and educate them on signs and symptoms of respiratory depression; if concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent.
  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, 5-HT3 receptor antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAO inhibitors): Concomitant use of opioids with drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. If concomitant use is warranted, frequently evaluate the patient, particularly during treatment initiation and dose adjustment; discontinue hydromorphone if serotonin syndrome is suspected.
  • Monoamine oxidase inhibitors (MAOIs) (phenelzine, tranylcypromine, linezolid): MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma). Use is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
  • Mixed agonist/antagonist and partial agonist opioid analgesics (butorphanol, nalbuphine, pentazocine, buprenorphine): May reduce the analgesic effect of hydromorphone and/or precipitate withdrawal symptoms. Avoid concomitant use.
  • Muscle relaxants (cyclobenzaprine, metaxalone): Hydromorphone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Decrease the dosage of hydromorphone and/or the muscle relaxant as necessary; consider recommending or prescribing an opioid overdose reversal agent.
  • Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Evaluate patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
  • Anticholinergic drugs: Concomitant use may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Evaluate patients for signs of urinary retention or reduced gastric motility.
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with Hydromorphone Hydrochloride. Table 1: Clinically Significant Drug Interactions with Hydromorphone Hydrochloride Benzodiazepines and other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions ( 5.4 )]. Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.2 , 5.3 , 5.4 )]. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Intervention: If concomitant use is warranted, frequently evaluate the patient, particularly during treatment initiation and dose adjustment. Discontinue Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets if serotonin syndrome is suspected.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿100 supplements and herbs with documented Hydromorphone interactions, ranked by severity Check Hydromorphone against a supplement or herb →

Before taking Hydromorphone

▾
  • Not for people with significant breathing problems, or acute or severe asthma without monitoring.
  • Not for blocked or narrowed digestive tract or paralytic ileus.
  • Not for people allergic to hydromorphone.
  • Extended-release tablets are not for people who are not opioid tolerant.
  • Tell your doctor about a history of addiction, alcohol misuse, or mental illness.
  • Pregnancy: may harm the baby and cause newborn withdrawal.
  • Breastfeeding is not recommended.
  • Older adults need slower, careful dosing.
  • Liver or kidney problems may call for lower doses or another pain medicine.

Hydromorphone overdose

▾

Overdose can cause slow breathing, extreme sleepiness progressing to coma, cold clammy skin, constricted pupils, low blood pressure and slow heart rate, and can be fatal. Call 911 right away. Treatment focuses on supporting breathing and giving an overdose reversal medicine such as naloxone or nalmefene. Extended-release tablets may need prolonged monitoring.

What Hydromorphone does in the body

▾

Hydromorphone relieves pain but also reduces breathing drive in the brain stem, in a dose-related way. It constricts pupils, slows the digestive tract and causes constipation, and can widen blood vessels, leading to low blood pressure or fainting. With long-term use it can affect hormones, and may lower sex drive or fertility.

How your body processes Hydromorphone

▾

Extended-release tablets release the drug gradually, with blood levels building over 6 to 8 hours and lasting about 18 to 24 hours. The average half-life is about 11 hours. Food does not affect the extended-release tablets. The liver breaks hydromorphone down, and most of it leaves in the urine as metabolites. Liver or kidney problems can raise drug levels.

How to store Hydromorphone

▾

Store at 20° to 25°C (68° to 77°F) . Protect from light. Store hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets securely and dispose of properly.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

100

Supplements & herbs that interact with Hydromorphone

100 supplements and herbal products have documented interactions with Hydromorphone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 7
  • Moderate · 78
  • Minor · 15
1,4-BUTANEDIOL Major ACTIVATED CHARCOAL Major BEER Major GAMMA-HYDROXYBUTYRATE (GHB) Major KAVA Major L-TRYPTOPHAN Major WINE Major 5-HTP Moderate +92 more
Every supplement checked against Hydromorphone — ranked by severity The full interaction hub: 7 major · 78 moderate · 15 minor · every one linked to its full report. Check Hydromorphone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Hydromorphone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Hydromorphone — the kind of thing our pharmacy team would talk through with you at the counter.

What is hydromorphone used for?

▾
It treats pain that is severe enough to need an opioid when other treatments haven't worked or aren't enough. Extended-release tablets are for daily, around-the-clock pain in people already used to opioids.

How should I take it safely?

▾
Take it exactly as prescribed, and never take extra doses. If you have the oral solution, use a proper measuring device, not a kitchen spoon, and check the dose in mL. Keep it locked away from children.

What side effects should I expect?

▾
Constipation, nausea, vomiting, sleepiness, headache and dizziness are the most common. Ask me about options for constipation. Call for help right away if breathing becomes slow or shallow or you can't stay awake.

Can I drink alcohol or take sleep or anxiety medicine with it?

▾
No, avoid alcohol. Combining it with alcohol, benzodiazepines or other sedating drugs can cause dangerous sleepiness, slowed breathing, coma and death. Tell me about everything you take, including antidepressants and muscle relaxants.

Can I take it if I'm pregnant or breastfeeding?

▾
Long-term use in pregnancy can cause withdrawal in the newborn, so talk to your doctor right away if you are pregnant or plan to be. Breastfeeding is not recommended because the baby can become overly sleepy or have breathing trouble.

Should I have naloxone at home?

▾
It's worth asking about, especially if children live in the home or you take other sedating medicines. Naloxone can reverse an opioid overdose, but you still need to call 911.

Is Hydromorphone available over the counter?

▾
No. Hydromorphone is a prescription medicine: every Hydromorphone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Hydromorphone a controlled substance?

▾
Yes — Hydromorphone is a federally controlled substance (Schedule II) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Hydromorphone first available?

▾
The earliest FDA record we hold for Hydromorphone is from 1972: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Hydromorphone was first used.

Who makes Hydromorphone?

▾
17 companies currently list Hydromorphone products in the FDA's NDC Directory, including Hikma Pharmaceuticals USA Inc., Rhodes Pharmaceuticals LLC, Fresenius Kabi USA, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Hydromorphone on HelloPharmacist

📊Hydromorphone supplement interactions100 checked — ranked by severity 🌿Drug & Supplement CheckerHydromorphone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Hydromorphone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Hydromorphone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Hydromorphone forms and strengths (how it comes)

Hydromorphone is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Hydromorphone inactive ingredients by manufacturer.

Injection

By injection · Into a muscle · Into a vein · Under the skin
Brands Dilaudid
How this form is used
What it may be used for
  • Dilaudid Injection and Hydromorphone Hydrochloride Injection are for pain severe enough to need an opioid when alternatives are inadequate.
  • Hydromorphone Hydrochloride Injection high potency formulation (HPF) is only for opioid-tolerant patients.
Important instructions
  • Hydromorphone Hydrochloride Injection can be given into a muscle, into a vein or under the skin.
  • Hydromorphone Hydrochloride Injection given into a vein should be given slowly.
Available strengths 8 strengths
0.2 mg/mL 0.25 mg/0.5 mL 0.5 mg/0.5 mL 1 mg/mL 2 mg/mL 4 mg/mL
Show 2 more strengths Show fewer strengths
10 mg/mL 100 mg/mL
72 FDA-listed product records ⓘ

Tablet

By mouth
Brands Dilaudid
How this form is used
What it may be used for
  • Dilaudid Tablets and Hydromorphone Hydrochloride Tablets are for pain severe enough to need an opioid when alternatives are inadequate.
Important instructions
  • Hydromorphone Hydrochloride Tablets should be used at the lowest effective dose for the shortest time.
  • Hydromorphone Hydrochloride Tablets are not meant for extended use unless pain stays severe and alternatives remain inadequate.
Available strengths 3 strengths
2 mg 4 mg 8 mg
59 FDA-listed product records ⓘ

Extended-release tablet

By mouth
How this form is used
What it may be used for
  • Hydromorphone hydrochloride extended-release tablets are for severe, persistent pain needing daily, long-term opioid treatment when alternatives are inadequate.
  • Hydromorphone hydrochloride extended-release tablets are not for as-needed pain relief.
Important instructions
  • Hydromorphone hydrochloride extended-release tablets may be taken with or without food.
  • Hydromorphone hydrochloride extended-release tablets are for opioid-tolerant patients only.
Available strengths 4 strengths
8 mg 12 mg 16 mg 32 mg
48 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Dilaudid
How this form is used
What it may be used for
  • Dilaudid Oral Solution and Hydromorphone Hydrochloride Oral Solution are for pain severe enough to need an opioid when alternatives are inadequate.
Important instructions
  • Hydromorphone Hydrochloride Oral Solution should be measured with a graduated device, never a household spoon.
  • Hydromorphone Hydrochloride Oral Solution has mg versus mL dosing confusion risk, so check the dose carefully.
Available strengths 2 strengths
1 mg/mL 5 mg/5 mL
12 FDA-listed product records ⓘ

Rectal suppository

Rectal
How this form is used
What it may be used for
  • Hydromorphone Hydrochloride suppositories are for pain severe enough to need an opioid when alternatives are not tolerated or inadequate.
Available strengths 1 strength
3 mg
4 FDA-listed product records ⓘ

Hydromorphone on the U.S. market: products, makers and brands

How Hydromorphone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

17 companies list 72 Hydromorphone product records with the FDA, mostly as injection, tablet, extended-release tablet; the earliest marketing or approval year on record is 1972. Brand names on the directory include Dilaudid, Exalgo; the rest are generics.

5
Dose forms ⓘ
17
Labelers (makers, repackagers, distributors)
2
Brand names
72
FDA-listed product records ⓘ
1972
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (18) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Hikma Pharmaceuticals USA Inc.11%
Rhodes Pharmaceuticals LLC11%
Fresenius Kabi USA, LLC10%
Hospira, Inc.10%
Padagis US LLC7%
Ascent Pharmaceuticals Inc6%
Other makers46%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Hydromorphone is used (Medicaid data)

A general measure of how commonly Hydromorphone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Hydromorphone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

367,041
Medicaid prescriptions filled (Q1–Q4 2025)
$15.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Hydromorphone prescribed? Of the 1,601 medications we measure, Hydromorphone ranks #296 by Medicaid prescriptions — more than 82% of them.

Where Hydromorphone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #296 of 1,601
#291 Zonisamide 395,289 Rx #292 Methimazole 378,542 Rx #293 Cyclosporine Ophthalmi... 377,528 Rx #294 Finasteride 375,944 Rx #295 Neomycin, Polymyxin, a... 367,823 Rx #296 Hydromorphone 367,041 Rx #297 Calcitriol 366,263 Rx #298 Enalapril 361,404 Rx #299 Desmopressin 357,369 Rx #300 Aripiprazole Injection 354,838 Rx #301 Emtricitabine and Teno... 354,223 Rx

Utilization by Hydromorphone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 2 mg oral tablet is the most-dispensed Hydromorphone product — about 25% of these Medicaid prescriptions.

hydromorphone hydrochloride 2 MG Oral Tablet Most dispensed

90,160 Medicaid prescriptions (Q1–Q4 2025) 25% of Hydromorphone prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 4 of 56 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897696

1 ML hydromorphone hydrochloride 1 MG/ML Cartridge

68,102 Medicaid prescriptions (Q1–Q4 2025) 19% of Hydromorphone prescriptions shown $3.4M gross reimbursement (before rebates) ≈ $49 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724383

0.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe

63,403 Medicaid prescriptions (Q1–Q4 2025) 17% of Hydromorphone prescriptions shown $3.8M gross reimbursement (before rebates) ≈ $60 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1433251

hydromorphone hydrochloride 4 MG Oral Tablet

63,212 Medicaid prescriptions (Q1–Q4 2025) 17% of Hydromorphone prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 5 of 76 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897702

1 ML hydromorphone hydrochloride 2 MG/ML Injection

21,706 Medicaid prescriptions (Q1–Q4 2025) 6% of Hydromorphone prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $60 per prescription (gross)

Summed across the 3 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724276

1 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe

18,691 Medicaid prescriptions (Q1–Q4 2025) 5% of Hydromorphone prescriptions shown $2.3M gross reimbursement (before rebates) ≈ $122 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897756

hydromorphone hydrochloride 8 MG Oral Tablet

14,889 Medicaid prescriptions (Q1–Q4 2025) 4% of Hydromorphone prescriptions shown $789,413 gross reimbursement (before rebates) ≈ $53 per prescription (gross)

Summed across the 2 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897710

1 ML hydromorphone hydrochloride 1 MG/ML Injection

10,502 Medicaid prescriptions (Q1–Q4 2025) 3% of Hydromorphone prescriptions shown $411,417 gross reimbursement (before rebates) ≈ $39 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897653

1 ML hydromorphone hydrochloride 2 MG/ML Cartridge

8,978 Medicaid prescriptions (Q1–Q4 2025) 2% of Hydromorphone prescriptions shown $668,598 gross reimbursement (before rebates) ≈ $74 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724644

hydromorphone hydrochloride 1 MG/ML Oral Solution

2,450 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $154,891 gross reimbursement (before rebates) ≈ $63 per prescription (gross)

Summed across the 3 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897657

1 ML hydromorphone hydrochloride 2 MG/ML Prefilled Syringe

1,570 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $68,876 gross reimbursement (before rebates) ≈ $44 per prescription (gross)

Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897757

1 ML hydromorphone hydrochloride 0.2 MG/ML Prefilled Syringe

1,472 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $185,016 gross reimbursement (before rebates) ≈ $126 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2277368

50 ML hydromorphone hydrochloride 10 MG/ML Injection

638 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $111,550 gross reimbursement (before rebates) ≈ $175 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724341

24 HR hydromorphone hydrochloride 8 MG Extended Release Oral Tablet

483 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $77,867 gross reimbursement (before rebates) ≈ $161 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 902741

5 ML hydromorphone hydrochloride 10 MG/ML Injection

234 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $38,959 gross reimbursement (before rebates) ≈ $166 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724340

0.5 ML hydromorphone hydrochloride 0.5 MG/ML Prefilled Syringe

202 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $809 gross reimbursement (before rebates) ≈ $4.00 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2675350

hydromorphone hydrochloride 2 MG/ML Injectable Solution

127 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $1,781 gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897745

24 HR hydromorphone hydrochloride 12 MG Extended Release Oral Tablet

87 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $26,300 gross reimbursement (before rebates) ≈ $302 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 902729

1 ML hydromorphone hydrochloride 10 MG/ML Injection

51 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $7,520 gross reimbursement (before rebates) ≈ $147 per prescription (gross)

Summed across the 3 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1724338

24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet

36 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $12,520 gross reimbursement (before rebates) ≈ $348 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 902736

1 ML hydromorphone hydrochloride 4 MG/ML Cartridge

24 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $2 gross reimbursement (before rebates) ≈ $0.06 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897758

hydromorphone hydrochloride 3 MG Rectal Suppository

12 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $6,930 gross reimbursement (before rebates) ≈ $578 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897749

1 ML hydromorphone hydrochloride 4 MG/ML Injection

12 Medicaid prescriptions (Q1–Q4 2025) <1% of Hydromorphone prescriptions shown $52 gross reimbursement (before rebates) ≈ $4.32 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 897753

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Hydromorphone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 45 of 259 listed Hydromorphone NDCs with Medicaid activity.

Compare Hydromorphone products

A representative set of FDA-listed product records for Hydromorphone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 72 of 72 products — FDA National Drug Code Directory. See every product, package size and price: browse all 72 Hydromorphone NDCs →

Hydromorphone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Hydromorphone recalls since July 2021.

✅No Hydromorphone recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Hydromorphone RxCUI 3423 10 dose forms · 32 strengths
  2. Dose form (SCDF) Extended Release Oral Capsule RxCUI 372427 No current FDA listing
    Clinical drug / strength (SCD) 12 HR hydromorphone hydrochloride 2 MG RxCUI 898611 12 HR hydromorphone hydrochloride 4 MG RxCUI 898614 12 HR hydromorphone hydrochloride 8 MG RxCUI 898618
  4. Dose form (SCDF) Injectable Solution RxCUI 370652 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 2 MG/ML RxCUI 897745
  6. Dose form (SCDF) Oral Capsule RxCUI 385569 No current FDA listing
    Clinical drug / strength (SCD) hydrochloride 1.3 MG RxCUI 898004 hydrochloride 2.6 MG RxCUI 898138
  7. Dose form (SCDF) Oral Solution RxCUI 370653 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 1 MG/ML RxCUI 897657
  10. Dose form (SCDF) Rectal Suppository RxCUI 370655 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 3 MG RxCUI 897749

Look up RxCUI 3423 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Hydromorphone costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 2 mg $0.169 per tablet NDC details & price history
Tablet · Oral 4 mg $0.219 per tablet NDC details & price history
Tablet · Oral 8 mg $0.561 per tablet NDC details & price history
Tablet, Extended Release · Oral 8 mg $5.73 per tablet NDC details & price history
Tablet, Extended Release · Oral 12 mg $10.42 per tablet NDC details & price history
Tablet, Extended Release · Oral 16 mg $12.38 per tablet NDC details & price history
Injection, Solution · Intramuscular; Intravenous; Subcutaneous 2 mg/mL $3.24 per mL NDC details & price history
Injection, Solution · Intramuscular; Intravenous; Subcutaneous 10 mg/mL $2.57 per mL NDC details & price history
Injection, Solution · Intramuscular, Intravenous, Subcutaneous 2 mg/mL $3.24 per mL NDC details & price history
Injection, Solution · Intramuscular, Intravenous, Subcutaneous 10 mg/mL $2.57 per mL NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Hydromorphone brand names

Hydromorphone is sold under 2 brand names in the FDA directory — Dilaudid, Exalgo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Dilaudid Exalgo

Who makes Hydromorphone: manufacturers and labelers

17 companies list Hydromorphone products with the FDA. By number of product records, the largest are Hikma Pharmaceuticals USA Inc., Rhodes Pharmaceuticals LLC, Fresenius Kabi USA, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Hikma Pharmaceuticals USA Inc. 8 Rhodes Pharmaceuticals LLC 8 Fresenius Kabi USA, LLC 7 Hospira, Inc. 7 Padagis US LLC 5 Ascent Pharmaceuticals Inc 4 Bryant Ranch Prepack 4 Camber Pharmaceuticals, Inc. 4 Trigen Laboratories, LLC 4 XLCare Pharmaceuticals, Inc. 4 Asclemed Usa Inc. 3 American Health Packaging 3 Aurolife Pharma, LLC 3 SpecGx LLC 3 Teva Parenteral Medicines, Inc. 3 Redpharm Drug 1 St. Mary's Medical Park Pharmacy 1

Hydromorphone drug class (RxNorm)

Hydromorphone belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Natural opium alkaloids
How it works Full Opioid Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Hydromorphone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 14, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Hydromorphone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Hydromorphone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
20
Finished products in the current FDA directory
72
Companies listing them (makers, repackagers, distributors)
17
FDA labeler codes behind them ⓘ
20
Linked representative label ⓘ
Rhodes Pharmaceuticals L.P.
Linked label effective
May 14, 2026
Composite sections available
27
Linked SPL Set ID
37565441-0d95-4743-a695-d7b3326f58a1
Linked SPL Document ID
b786b01b-46f9-4a00-a667-699e813a741b
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Rhodes Pharmaceuticals L.P. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →