Hydromorphone

Hydromorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of hydromorphone is analgesia.

• Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

• Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12) ] Hypersensitivity to hydromorphone, hydromorphone salts, any other components of the product, or sulfite-containing medications (e.g., anaphylaxis) [see Warnings and Precautions (5.16) , Adverse Reactions (6.1) ] Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.contraindicated

Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets 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 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 , 5.2 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with hydromorphone hydrochloride. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.3 ) Discuss availability of naloxone with the patient and caregiver and assess each patient's need for access to naloxone, both when initiating and renewing treatment with hydromorphone hydrochloride.

Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.7 ) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Regularly evaluate patients, particularly during initiation and titration. ( 5.8 ) Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 ) Severe Hypotension: Regularly evaluate patients during dosage initiation and titration. Avoid use of hydromorphone hydrochloride oral solution or hydromorphone hydrochloride tablets in patients with circulatory shock. ( 5.10 ) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor patients for sedation and respiratory depression. Avoid use of hydromorphone hydrochloride oral solution or hydromorphone hydrochloride tablets in patients with impaired consciousness or coma. ( 5.11 ) 5.1 Risk of Accidental Overdose and Death due to Medication Errors Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with other hydromorphone oral solutions of different concentrations, when prescribing, dispensing, and administering hydromorphone hydrochloride oral solution.

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.2) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.4) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Severe Hypotension [see Warnings and Precautions (5.10) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12) ] Seizures [see Warnings and Precautions (5.13) ] Withdrawal [see Warnings and Precautions (5.14) ] Most common adverse reactions are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhodes Pharmaceuticals at 1-888-827-0616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Pregnancy: May cause fetal harm. ( 8.1 ) 8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5) ]. There are no available data with hydromorphone hydrochloride in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, reduced postnatal survival of pups, and decreased were noted following oral treatment of pregnant rats with hydromorphone during gestation and through lactation at doses 0.8 times the human daily dose of 24 mg/day (HDD), respectively. In published studies, neural tube defects were noted following subcutaneous injection of hydromorphone to pregnant hamsters at doses 6.4 times the HDD and soft tissue and skeletal abnormalities were noted following subcutaneous continuous infusion of 3 times the HDD to pregnant mice. No malformations were noted at 4 or 40.5 times the HDD in pregnant rats or rabbits, respectively [see Data ]. Based on animal data, advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

Absorption The analgesic activity of hydromorphone hydrochloride is due to the parent drug, hydromorphone. Hydromorphone is rapidly absorbed from the gastrointestinal tract after oral administration and undergoes extensive first-pass metabolism.

Clinical Presentation Acute overdose with hydromorphone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2) ] . Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures. Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist.

• Jan 11, 1984NDANDA019034Fresenius Kabi Usa
• Dec 7, 1992NDANDA019891Rhodes Pharms
• Dec 7, 1992NDANDA019892Rhodes Pharms
• Jul 29, 1998ANDAANDA074653Hikma
• Dec 23, 2004ANDAANDA076855Specgx Llc
• Jun 17, 2008ANDAANDA078591Hospira Inc
• Dec 1, 2011NDANDA200403Hospira Inc
• Dec 14, 2023NDANDA217812Hikma

1. 1Drug Dependence35,09039%
2. 2Overdose23,02225%
3. 3Pain22,20724%
4. 4Emotional Distress17,68819%
5. 5Death14,89416%
6. 6Drug Withdrawal Syndrome14,32316%
7. 7Toxicity To Various Agents10,06911%
8. 8Nausea4,6755.1%
9. 9Drug Ineffective4,4094.8%
10. 10Fatigue3,5683.9%
11. 11Vomiting3,4493.8%
12. 12Anxiety3,3663.7%
13. 13Off Label Use3,3233.7%
14. 14Drug Abuse3,1093.4%
15. 15Headache2,9693.3%

Recent PubMed references pinned to Hydromorphone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Stability and Compatibility of an Admixture Containing Hydromorphone, Bupivacaine, and Dexamethasone in 0.9% Sodium Chloride Injection for Intrathecal Analgesia.
  Medical science monitor : international medical journal of experimental and clinical research · 2026 · Wang Z, Wang F, Li Y, et al.
  PMID 42219744DOI 10.12659/MSM.952388
• Comparative Effectiveness of Single-Dose Epidural Esketamine versus Hydromorphone in Thoracic and Upper Abdominal Surgery: A Randomized Trial.
  Drug design, development and therapy · 2026 · Song Y, Wang C, Huang N, et al.
  PMID 41884486DOI 10.2147/DDDT.S580521
• Antinociceptive effects of subcutaneous hydromorphone in bearded dragons (Pogona vitticeps).
  Veterinary anaesthesia and analgesia · 2026 · Elzinga CD, Johnson AN, Alexander AB, et al.
  PMID 41795280DOI 10.1016/j.vaa.2026.101204
• Cardiopulmonary effects of alfaxalone-midazolam-hydromorphone or dexmedetomidine-midazolam-hydromorphone before isoflurane anesthesia in healthy rabbits (Oryctolagus cuniculus).
  Veterinary anaesthesia and analgesia · 2026 · Toy S, Desprez I, Beazley S, et al.
  PMID 41719770DOI 10.1016/j.vaa.2026.101198
• Identifying Adverse Events Associated With High-Risk Opioid Administration Using the Emergency Department Trigger Tool.
  Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2026 · Griffey RT, Bollam N, Schneider RM, et al.
  PMID 41689235DOI 10.1111/acem.70216
• Morphine and hydromorphone pharmacodynamics in human volunteers: population-based modelling of interindividual response variability and utility.
  British journal of anaesthesia · 2026 · Olofsen E, Meissner K, Dahan A, et al.
  PMID 41656122DOI 10.1016/j.bja.2025.11.060
• Safety Analysis of IV Methadone vs. IV Hydromorphone in Post-Procedural Adults.
  Journal of pain & palliative care pharmacotherapy · 2026 · Serniak A, McCormick PJ, Pursglove ML, et al.
  PMID 41557719DOI 10.1080/15360288.2026.2615074
• Acetaminophen (Paracetamol) or Opioid Analgesia Added to Ibuprofen for Children's Musculoskeletal Injury: Two Randomized Clinical Trials.
  JAMA · 2026 · Ali S, Klassen TP, Candelaria P, et al.
  PMID 41505155DOI 10.1001/jama.2025.25033

The 10 most recently updated of 336 ClinicalTrials.gov registrations naming Hydromorphone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• MCID and PASS for Acute Pain and Quality of Recovery After Orthopedic Surgery
  Recruiting · Observational · 300 enrolled · University Health Network, Toronto
  NCT04811209updated 2026-06-10
• Fentanyl Versus Hydromorphone in Patients on Mechanical Ventilation
  Active not recruiting · Phase 2 · Interventional · 300 enrolled · Beth Israel Deaconess Medical Center
  NCT07224620updated 2026-05-29
• Recommendations of Enhanced Recovery Interventions for Patient's Clinical Team and Collection of Associated Data
  Completed · Phase 3 · Interventional · 3,395 enrolled · Jennifer Holder-Murray
  NCT04606264updated 2026-05-28
• Effect of Opioid-Sparing Anesthesia on Postoperative Opioid Consumption and Pain in Elderly Patients Undergoing Spine Surgery
  Not yet recruiting · Phase 2 · Interventional · 120 enrolled · Massachusetts General Hospital
  NCT07588802updated 2026-05-15
• A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair
  Terminated · Phase 4 · Interventional · 31 enrolled · Mayo Clinic
  NCT05552443updated 2026-05-14
• Opioid Tapering After Hospital Discharge: Testing an Intervention to Improve Post-operative Opioid Prescribing
  Recruiting · Interventional · 42 enrolled · Montefiore Medical Center
  NCT07510373updated 2026-05-11
• Behavioral Effects of Drugs (Inpatient): 43 (Opioids, Cocaine, n-Acetylcysteine)
  Completed · Early phase 1 · Interventional · 12 enrolled · William Stoops
  NCT05610072updated 2026-05-05
• Methadone for Enhanced Postoperative Analgesia in Intermediate-Risk Noncardiac Surgery (MELODY)
  Not yet recruiting · Phase 3 · Interventional · 400 enrolled · Alexandre P. Joosten
  NCT07565870updated 2026-05-04
• Opioid Sparing Effect of an ISP Nerve Block on Post-Op Pain Control in Posterior Cervical Spine Surgery
  Recruiting · Interventional · 60 enrolled · Stony Brook University
  NCT06570577updated 2026-04-29
• Anesthetics and Analgesics in Children
  Recruiting · Observational · 500 enrolled · Chi Dang Hornik
  NCT03427736updated 2026-04-29

CPIC-curated drug–gene pairs for Hydromorphone. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• COMTCPIC C
  CYP2D6, OPRM1, COMT, and Opioids
• OPRM1CPIC C
  CYP2D6, OPRM1, COMT, and Opioids

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

• HydrocodoneOpioid Agonist99%
• OxymorphoneOpioid Agonist96%
• OxycodoneOpioid Agonist95%
• NaloxoneOpioid Antagonist94%
• NaltrexoneOpioid Antagonist94%
• MorphineOpioid Agonist88%
• CodeineOpium alkaloids and derivatives87%
• BuprenorphinePartial Opioid Agonist84%

Frequently asked questions

How does Hydromorphone work?

Hydromorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of hydromorphone is analgesia.

What is Hydromorphone used for?

According to FDA labeling, Hydromorphone carries indications including: Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Hydromorphone?

Hydromorphone is classified as Natural opium alkaloids, Opioid Agonist, Full Opioid Agonists, Opioid mu-Receptor Agonists, Analgesia, Decreased Central Nervous System Organized Electrical Activity, Decreased Organized Electrical Activity.

What are the brand names for Hydromorphone?

Hydromorphone is marketed under brand names including Dilaudid, Dilaudid Cough.

What are the contraindications for Hydromorphone?

Hydromorphone labeling lists contraindications including: Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12) ] Hypersensitivity to hydromorphone, hydromorphone salts, any other components of the product, or sulfite-containing medications (e.g., anaphylaxis) [see Warnings and Precautions (5.16) , Adverse Reactions (6.1) ] Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.. Always consult the full prescribing information and a clinician.