Hydromorphone
Hydagelan, Hydal, Hydromorphon Glenmark, Hydromorphon Hameln · ATC code N02AA03
Also known as: Hydromorphon, Hidromorfon · Brand names: Hydagelan, Hydal, Hydromorphon Glenmark, Hydromorphon Hameln, Hydromorphon Heumann, Hydromorphon Kalceks, Hydromorphon Ratiopharm, Hydromorphon Stada, Dolomorphon, Hydromorphonhydrochlorid Beta, Palladon, Palladone, Dilaudid
- Key facts
- Active substance
- Hydromorphone
- Drug class
- Opioid
- ATC code
- N02AA03
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
Boxed warning
Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering hydromorphone hydrochloride oral solution. Dosing errors due to confusion between mg and mL, and other hydromorphone oral solutions of different concentrations can result in accidental overdose and death [see Dosage and Administration (2.1), Warnings and Precautions (5.1)].
Addiction, Abuse, and Misuse
Because the use of hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.2)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are essential [see Warnings and Precautions (5.3)].
Accidental Ingestion
Accidental ingestion of even one dose of hydromorphone hydrochloride oral solution or hydromorphone hydrochloride tablets, especially by children, can result in a fatal overdose of hydromorphone [see Warnings and Precautions (5.3)].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.4), Drug Interactions (7)].
Neonatal Opioid Withdrawal Syndrome (NOWS)
Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.5)] .
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.6)].
Key facts
Hydromorphone is an opioid analgesic. Per the US prescribing information, its oral solution and tablets are used for pain severe enough to require an opioid when alternatives are inadequate.
What it is used for
- Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
Dosing
- Oral solution: start 2.5 mL to 10 mL (2.5 mg to 10 mg) every 3 to 6 hours as needed
- Tablets: start 2 mg to 4 mg orally every 4 to 6 hours as needed
- Hepatic or renal impairment: start with one-fourth to one-half the usual starting dose
- Always measure the solution with a graduated oral syringe or measuring cup, never household spoons; write both the dose in mg and the volume on prescriptions
- Lowest effective dosage for the shortest duration; conversion from other opioids: see the full text
Contraindications
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting
- Known or suspected gastrointestinal obstruction including paralytic ileus
- Hypersensitivity to hydromorphone, product components or sulfite-containing medications
Important warnings
- Boxed warning: dosing errors from confusion between mg and mL or between solutions of different concentrations can cause fatal overdose
- Boxed warning: addiction, abuse and misuse; life-threatening respiratory depression, especially at initiation and after dose increases; accidental ingestion can be fatal
- Boxed warning: use with benzodiazepines or other CNS depressants including alcohol may cause profound sedation, coma and death
- Neonatal opioid withdrawal syndrome; also adrenal insufficiency, severe hypotension, seizures, withdrawal
Side effects
- Most common: lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth and pruritus
- Serious: respiratory depression and apnea, less often circulatory depression, respiratory arrest, shock and cardiac arrest
Interactions
- Benzodiazepines and other CNS depressants including alcohol, muscle relaxants: respiratory depression, hypotension, coma
- Serotonergic drugs: serotonin syndrome
- MAOIs: not concurrently or within 14 days of stopping them
- Mixed agonist/antagonist and partial agonist opioids may reduce the effect; diuretics and anticholinergics: see the full text
Pregnancy and breastfeeding
- Prolonged use during pregnancy may cause neonatal opioid withdrawal syndrome
- Low levels of opioids detected in human milk; weigh breastfeeding benefits against potential risks
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Austria
- HydagelanG.L. Pharma Gmbh · 2 register entries
- HydalMundipharma Gesellschaft M.B.H. · 4 register entries
- Hydromorphon GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
- Hydromorphon HamelnHameln Pharma Gmbh · 1 register entry
- Hydromorphon HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
- Hydromorphon KalceksKalceks · 1 register entry
- Hydromorphon RatiopharmTeva B.V · 1 register entry
- Hydromorphon StadaStada Arzneimittel Gmbh · 2 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- DolomorphonG.L. Pharma Gmbh · 2 register entries
- HydagelanG.L. Pharma Gmbh · 1 register entry
- Hydromorphon1 A Pharma Gmbh, Pb Pharma Gmbh, Ratiopharm Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Hormosan Pharma Gmbh, Hexal Ag, Glenmark Arzneimittel Gmbh, Aristo Pharma Gmbh (Art 57), Puren Pharma Gmbh & Co. Kg, Clinigen Healthcare B.V., Winthrop Arzneimittel Gmbh, Kalceks, Abz-Pharma Gmbh, Hameln Pharma Gmbh, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Viatris Germany Gmbh, Aliud Pharma Gmbh · 31 register entries
- Hydromorphonhydrochlorid BetaBetapharm Arzneimittel Gmbh · 1 register entry
- PalladonMundipharma Gmbh · 5 register entries
- PalladonePb Pharma Gmbh · 2 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
USA
- DilaudidFresenius Kabi USA, LLC, Rhodes Pharmaceuticals LLC · 2 register entries
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29
Brand names in 17 more European countries
- Belgium
- Palladone
- Czechia
- Palladone
- Denmark
- Hydromorphonhydrochlorid Kalceks, Palladon
- Estonia
- Hydromorphone Kalceks
- Finland
- Hydofon, Hydromorphone Kalceks, Palladon
- France
- Hydagelan Lp, Sophidone L.P.
- Ireland
- Hydromorphone Hydrochloride Ethypharm, Hydromorphone Kalceks, Palladone
- Italy
- Medepidol, Tiblelan
- Liechtenstein
- Jurnista
- Luxembourg
- Hydromorphon Hameln, Palladone
- Malta
- Hydromorphone Aristo, Hydromorphone Quintian
- Netherlands
- Hydagelan, Hydromorfonhydrochloride Kalceks, Palladon
- Norway
- Hydofon, Hydromorfonhydroklorid Kalceks, Palladon
- Portugal
- Edunix, Hidromorfona Aristo
- Slovakia
- Palladone-Sr Capsules
- Spain
- Edunix
- Sweden
- Gerodolan, Hydofon, Hydromorphone Kalceks, Palladon
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- U.S. Food and Drug Administration. Hydromorphone Hydrochloride (Rhodes Pharmaceuticals LLC) – Prescribing Information, 2026-05-14. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37565441-0d95-4743-a695-d7b3326f58a1
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC N02AA.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.