Hydromorphone: uses, dosing, side effects & brands
Hydromorphone is an opioid agonist sold in the U.S. under 5 brand and generic names, for cough and postoperative pain. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Opioid Agonist
- Treats (across its forms)
- Cough and Postoperative Pain
- Available as
- Tablet, extended release · Injectable · Solution · Tablet · Suppository · Capsule, extended release
- Sold as
- 5 products — Exalgo, Dilaudid and Dilaudid-Hp, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 2.3 hours (terminal elimination half-life after an intravenous dose); after an oral dose the label reports a mean T½ of about 2.6 hours for the 8 mg tablet and 2.8 hours for the oral liquid
- What the pharmacy pays
- about $0.57 per ml — not your price
- Boxed warning
- Boxed warning
How Dilaudid is dosed
From the FDA label for Dilaudid (application NDA019034). Other hydromorphone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
DILAUDID INJECTION should be prescribed only by healthcare professionals who are knowledgeable about the use of 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 Injection 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 ) • Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) • 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 Injection. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.2 ) • Initial Dosage: - Intramuscular or Subcutaneous Use: The usual…
Everything below is the FDA label for Dilaudid (injectable, solution, tablet). Hydromorphone is also sold as tablet, extended release, suppository and capsule, extended release, and those are different medicines to take — follow the label for the one you were prescribed.
Dilaudid side effects
The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] • Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.2 )] • Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions ( 5.3 )] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.4 )] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.5 )] • Adrenal Insufficiency [see Warnings and Precautions ( 5.7 )] • Severe Hypotension [see Warnings and Precautions ( 5.8 )] • Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.10 )] • Seizures [see Warnings and Precautions ( 5.11 )] • Withdrawal [see Warnings and Precautions ( 5.12 )] The following adverse reactions associated with the use of hydromorphone were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions associated with DILAUDID INJECTION include respiratory depression and apnea and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest. The most common adverse effects…
Who shouldn’t take Dilaudid
DILAUDID INJECTION is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions ( 5.2 )] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.6 )] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.10 )] • Hypersensitivity to hydromorphone, hydromorphone salts, any other components of the product, or sulfite containing medications (e.g., anaphylaxis) [see Warnings and Precautions ( 5.14 )] • Significant respiratory depression. ( 4 ) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) • Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) • Known hypersensitivity to hydromorphone, hydromorphone salts, sulfite-containing medications, or any other components of the product. ( 4 )
Dilaudid drug interactions
Table 1 includes clinically significant drug interactions with DILAUDID INJECTION. Table 1. Clinically Significant Drug Interactions with DILAUDID INJECTION Benzodiazepines and other Central Nervous System Depressants (CNS) Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. [see Warnings and Precautions ( 5.3 )] 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. Monitor patients closely for signs of respiratory depression and sedation [see Warnings and Precautions ( 5.3 )]. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, 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, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue DILAUDID INJECTION if serotonin syndrome is suspected. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions ( 5.2 )]. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. Intervention: The use of DILAUDID INJECTION 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. Examples: phenelzine, tranylcypromine, linezolid Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics Clinical Impact: May reduce the analgesic effect of DILAUDID INJECTION and/or precipitate withdrawal syndrome. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Hydromorphone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of DILAUDID INJECTION and/or the muscle relaxant as necessary. Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. Anticholinergic Drugs Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when DILAUDID INJECTION is used concomitantly with anticholinergic drugs. • Serotonergic Drugs : Concomitant use may result in serotonin syndrome. Discontinue DILAUDID INJECTION if serotonin syndrome is suspected. ( 7 ) • Monoamine Oxidase Inhibitors (MAOIs) : Can potentiate the effects of hydromorphone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI. ( 7 ) • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics : Avoid use with DILAUDID INJECTION because they may reduce analgesic effect of DILAUDID INJECTION or precipitate withdrawal symptoms. ( 7 )
Every hydromorphone product we track (5)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $1 | View → | |
| 2 | 68/100 | Prescription | Injectable | Generic | $1 | View → | |
| 3 | 68/100 | Prescription | Injectable | Generic | $1 | View → | |
| 4 | 44/100 | Prescription | Suppository | Generic | $1 | View → | |
| 5 | Not yet rated | Prescription | Capsule | Generic | $1 | View → |
What hydromorphone pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Hydromorphone recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long hydromorphone keeps
The date on a sealed pack is not the only one: some hydromorphone labels start a second clock once the product is opened or mixed, as short as 24 hours.
Does hydromorphone expire? The in-use limits and storage rules from its labelsHydromorphone and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for hydromorphone: levels in milk, effects in breastfed infants, and the drugs it would consider insteadLimited data indicate that hydromorphone is excreted into breastmilk in small amounts, but large maternal dosages have caused neonatal central nervous system depression. In general, Maternal use of oral opioids during breastfeeding can cause infant drowsiness, which may progress to rare but severe central nervous system depression. Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. If hydromorphone is required by the mother of a newborn, it is not a reason to discontinue breastfeeding; however, once the mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of hydromorphone to 2 to 3 days at a low dosage with close infant monitoring. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped.
National Institute of Child Health and Human Development, record revised June 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about hydromorphone
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 13,133 reports naming hydromorphone, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- nausea1,831 reports
- drug hypersensitivity1,664 reports
- vomiting1,546 reports
- headache1,463 reports
- fatigue1,328 reports
- dyspnoea1,191 reports
- pneumonia1,173 reports
- asthma1,111 reports
Read these as a signal, not a rate. A report does not mean hydromorphone caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
How long hydromorphone stays in your system
The elimination half-life of hydromorphone is about 2.3 hours (terminal elimination half-life after an intravenous dose); after an oral dose the label reports a mean T½ of about 2.6 hours for the 8 mg tablet and 2.8 hours for the oral liquid. These are the terminal (elimination) values the label gives, not a distribution phase. No longer-lasting active metabolite: the label states plainly that "the analgesic activity of hydromorphone hydrochloride is due to the parent drug, hydromorphone." Over 95% of a dose is converted to hydromorphone-3-glucuronide (plus minor 6-hydroxy reduction metabolites), which the label does not describe as analgesically active. Hydromorphone is not a prodrug. Kidney impairment: the drug is cleared more slowly — in the label's renal study, severe impairment (CLcr under 30 mL/min) gave a terminal half-life of about 40 hours versus about 15 hours in people with normal kidneys, and exposure rose 2-fold in moderate and 3-fold in severe impairment. Note the label's own inconsistency: that study's "normal kidney" comparator (about 15 hours) is much longer than the roughly 2.3-2.8 hours reported elsewhere in the same label, likely because of longer blood sampling; the label prints both without reconciling them, so treat the ~40 vs ~15 hour figures as a relative comparison within that one study rather than as the everyday number. Liver impairment: moderate impairment (Child-Pugh B) raised exposure about 4-fold; the label does not report a half-life for it, and severe impairment was never studied. Older adults: the label says age has no effect on hydromorphone pharmacokinetics. This is elimination from blood, not a drug-test detection window (metabolites stay detectable much longer), and it is not dosing guidance.
HYDROMORPHONE HYDROCHLORIDE tablet - FDA label, Section 12.3 Pharmacokinetics (DailyMed) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related guides
Related calculators
Frequently asked questions
What is Dilaudid?
DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid agonist. DILAUDID INJECTION is available as a sterile, aqueous solution in clear and colorless single-dose prefilled syringes for slow intravenous, subcutaneous, or intramuscular administration. Each 1 mL of solution contains 0.2 mg, 1 mg or 2 mg of hydromorphone hydrochloride.
What kind of drug is hydromorphone?
The FDA classifies hydromorphone as an opioid agonist. Opioid agonists bind opioid receptors (mainly mu receptors) on nerves in the brain and spinal cord, dampening the release of pain-signaling chemicals so fewer pain messages reach the brain, which relieves moderate to severe pain. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does hydromorphone stay in your system?
The elimination half-life of hydromorphone is about 2.3 hours (terminal elimination half-life after an intravenous dose); after an oral dose the label reports a mean T½ of about 2.6 hours for the 8 mg tablet and 2.8 hours for the oral liquid — that is how long the body takes to clear half of a dose. These are the terminal (elimination) values the label gives, not a distribution phase. No longer-lasting active metabolite: the label states plainly that "the analgesic activity of hydromorphone hydrochloride is due to the parent drug, hydromorphone." Over 95% of a dose is converted to hydromorphone-3-glucuronide (plus minor 6-hydroxy reduction metabolites), which the label does not describe as analgesically active. Hydromorphone is not a prodrug. Kidney impairment: the drug is cleared more slowly — in the label's renal study, severe impairment (CLcr under 30 mL/min) gave a terminal half-life of about 40 hours versus about 15 hours in people with normal kidneys, and exposure rose 2-fold in moderate and 3-fold in severe impairment. Note the label's own inconsistency: that study's "normal kidney" comparator (about 15 hours) is much longer than the roughly 2.3-2.8 hours reported elsewhere in the same label, likely because of longer blood sampling; the label prints both without reconciling them, so treat the ~40 vs ~15 hour figures as a relative comparison within that one study rather than as the everyday number. Liver impairment: moderate impairment (Child-Pugh B) raised exposure about 4-fold; the label does not report a half-life for it, and severe impairment was never studied. Older adults: the label says age has no effect on hydromorphone pharmacokinetics. This is elimination from blood, not a drug-test detection window (metabolites stay detectable much longer), and it is not dosing guidance. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take hydromorphone with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run hydromorphone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is hydromorphone sold under?
We track 5 hydromorphone-containing products in the U.S.: Exalgo, Dilaudid, Dilaudid-Hp, Hydromorphone Hydrochloride and Palladone. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does hydromorphone come in?
Across the brands we track, hydromorphone is currently marketed as tablet, extended release, injectable, solution, tablet, suppository and capsule, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic hydromorphone?
Yes. Our catalog lists 1 generic hydromorphone product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has hydromorphone been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions hydromorphone. The most recent: Hydromorphone HCL PF (Oct 9, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
How long does hydromorphone stay in your system and show up on a urine drug test?
Hydromorphone is generally detectable in urine for about 1 to 3 days after the last dose. It is a semi-synthetic opioid, and standard opiate immunoassays detect it only inconsistently, so labs often need a specific test or confirmatory GC-MS or LC-MS to identify it reliably. Detection times are approximate and depend on dose, extended-release versus immediate-release form, frequency of use, and liver and kidney function. This is general information, not medical or legal advice.
How long is hydromorphone detectable in blood, saliva, and hair?
Approximate toxicology ranges: blood about 12 to 24 hours, oral fluid (saliva) roughly 1 to 3 days, and hair up to about 90 days. Blood has the shortest window and hair the longest. These are estimates that vary by individual based on dose and metabolism.
Will hydromorphone trigger a positive on a standard opiate screen?
Not reliably. Standard opiate immunoassays are optimized for morphine and codeine and cross-react only variably with semi-synthetic opioids like hydromorphone, so it can be missed at typical cutoffs — confirmatory testing is more dependable. If you take prescribed hydromorphone (for example, Dilaudid), tell the lab or Medical Review Officer so your result is interpreted correctly. Windows vary between people and this is not medical or legal advice.
Cite this page
- APA
- pharmaranks. (2026, July 24). Hydromorphone: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/hydromorphone
- MLA
- “Hydromorphone: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/hydromorphone.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for hydromorphone on DailyMed (NIH) ↗ — including its boxed warning in full.