Morphine

Compensan Retard, Morphinhydrochlorid Retard Lannacher, Mundidol, Oramorph · ATC code N02AA01

Also known as: Morphin, Morfin, Morphine Sulfate · Brand names: Compensan Retard, Morphinhydrochlorid Retard Lannacher, Mundidol, Oramorph, Substitol, Vendal, Capros, M-Beta, M-Long, M-Stada, Molnex, Morphinsulfat Abz, Morphinsulfat Dopiopharm, Morphinsulfat Gry, Morphinsulfat Hameln …

Key facts
Active substance: Morphine
Drug class: Opioid
ATC code: N02AA01
Authorisation: authorised nationally; no central EU authorisation
Information as of: 2026-10-27

Boxed warning

Addiction, Abuse, and Misuse

Because the use of Morphine Sulfate Tablets exposes 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 (5.1)].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Morphine Sulfate Tablets are essential [see Warnings and Precautions (5.2)].

Accidental Ingestion

Accidental ingestion of even one dose of Morphine Sulfate Tablets, especially by children, can result in a fatal overdose of morphine [see Warnings and Precautions (5.2)].

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 Morphine Sulfate Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3), 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 (5.4)].

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 (5.5)].

Key facts

Morphine is an opioid agonist. Per the US prescribing information, the tablets are used for acute and chronic pain severe enough to require an opioid when alternative treatments are inadequate.

What it is used for

Acute pain in adults and pediatric patients weighing at least 50 kg, when an opioid is needed and alternatives are inadequate
Chronic pain in adults under the same conditions
Reserved for patients in whom other options are ineffective or inadequate, because of addiction, abuse and overdose risks

Dosing

Lowest effective dosage for the shortest duration; prescribed by professionals knowledgeable in opioid use
Opioid-naive adults: 15 mg to 30 mg every 4 hours as needed, then titrate to response
Pediatric patients at least 50 kg: 15 mg every 4 hours as needed; initial dose not exceeding 30 mg
Cirrhosis and renal failure: start with a lower dosage and titrate slowly
Do not abruptly discontinue in physically dependent patients
Inform patients about overdose reversal agents (e.g., naloxone); conversion schemes are in the full text

Contraindications

Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
MAOIs concurrently or within the last 14 days
Known or suspected gastrointestinal obstruction, including paralytic ileus
Hypersensitivity to morphine

Important warnings

Boxed warning: addiction, abuse and misuse, with risk of overdose and death
Boxed warning: life-threatening respiratory depression, especially at initiation and after dose increases
Boxed warning: accidental ingestion, especially by children, can be fatal
Boxed warning: with benzodiazepines or other CNS depressants (including alcohol), profound sedation, coma and death
Neonatal opioid withdrawal syndrome with prolonged use in pregnancy
Adrenal insufficiency, severe hypotension, seizures, opioid-induced hyperalgesia

Side effects

Serious: respiratory depression, apnea, circulatory depression, respiratory arrest, shock, cardiac arrest
Common on initiation: nausea, vomiting, constipation
Addiction, withdrawal, sedation

Interactions

Benzodiazepines and other CNS depressants including alcohol: hypotension, respiratory depression, coma, death
MAOIs contraindicated; further interactions in Table 1 of the label

Pregnancy and breastfeeding

Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome
Morphine is present in breast milk

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

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

Compensan RetardG.L. Pharma Gmbh · 1 register entry
Morphinhydrochlorid Retard LannacherG.L. Pharma Gmbh · 2 register entries
MundidolMundipharma Gesellschaft M.B.H. · 5 register entries
OramorphL. Molteni And C. Dei F.Lli Alitti Società Di Esercizio S.P.A. · 1 register entry
SubstitolMundipharma Gesellschaft M.B.H. · 1 register entry
VendalG.L. Pharma Gmbh · 4 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

CaprosEthypharm · 3 register entries
M-BetaBetapharm Arzneimittel Gmbh · 1 register entry
M-LongEthypharm · 1 register entry
M-StadaStadapharm Gmbh · 3 register entries
MolnexKalceks · 1 register entry
MorphinAliud Pharma Gmbh, Merck Healthcare Germany Gmbh, Aristo Pharma Gmbh (Art 57), Ratiopharm Gmbh, G.L. Pharma Gmbh, Ps Marketing And Outsourcing Gmbh, Ps Marketing Und Outsourcing Gmbh, Laboratórios Basi – Indústria Farmacêutica, S.A. · 18 register entries
Morphinsulfat AbzAbz-Pharma Gmbh · 1 register entry
Morphinsulfat DopiopharmPs Marketing Und Outsourcing Gmbh · 1 register entry
Morphinsulfat GryTeva Gmbh · 5 register entries
Morphinsulfat HamelnHameln Pharma Gmbh · 1 register entry
MsiMundipharma Gmbh · 1 register entry
MstMundipharma Gmbh · 2 register entries

Show all 18 brand names

OramorphL. Molteni And C. Dei F.Lli Alitti Società Di Esercizio S.P.A. · 2 register entries
PainbreakPb Pharma Gmbh · 1 register entry
RemosanG.L. Pharma Gmbh · 1 register entry
SendolorEurocept International Bv · 1 register entry
SevredolMundipharma Gmbh, Pb Pharma Gmbh · 2 register entries
SubstitolMundipharma Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

Hazir EnjektorNOBEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
M-EslonNOBEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
MorfiaİLKO İLAÇ SAN.VE TİC. A.Ş. · 7 register entries
Morfin Hidroklorür OselOSEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
MORPHINE HClGALEN İLAÇ SAN.VE TİC.A.Ş · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

DuramorphHikma Pharmaceuticals USA Inc. · 1 register entry
Infumorph 200Hikma Pharmaceuticals USA Inc. · 1 register entry
Infumorph 500Hikma Pharmaceuticals USA Inc. · 1 register entry
MitigoPiramal Critical Care, Inc. · 1 register entry
MS ContinRhodes Pharmaceuticals LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 26 more European countries

Belgium: Morphine Hcl Sterop, Morphine Teva, Ms Contin, Ms Direct
Bulgaria: Substitol, Морфин Софарма, Субститол
Croatia: Morfinklorid Alkaloid, Mst Continus, Oramorph, Sevredol
Cyprus: Sevredol
Czechia: Morphin Bbp, Morphine Kalceks, Sevredol, Vendal Retard
Denmark: Contalgin, Depolan, Doltard, Malfin, Morfin Abcur, Morfin Dak, Morfin Dlf, Morfin Eql Pharma, Morfin Sad, Oramorph, Sendolor
Estonia: Mxl, Sevredol, Vendal Retard
Finland: Molnex, Morphin Evolan Pharma, Morphine Hydrochloride Evolan Pharma, Sendolor
France: Actiskenan, Lunetra, Molnex, Morphine (Chlorhydrate) Aguettant, Morphine (Chlorhydrate) Cooper, Morphine (Chlorhydrate) Lavoisier, Morphine (Chlorhydrate) Renaudin, Morphine (Sulfate) Lavoisier, Moscontin, Oramorph, Sevredol, Skenan L.P., Sulfate De Morphine Lp Ethypharm
Hungary: Morphine Kalceks, Morphinum Hydrochloricum Teva, Mst Continus, Sevredol
Iceland: Contalgin, Morfin Abcur, Morphine Sulfate Kalceks
Ireland: Morphine Sulfate As Kalceks, Morphine Sulfate Mercury Pharmaceuticals (Ireland), Morphine Sulphate Ethypharm, Morphine Sulphate Mercury Pharmaceuticals (Ireland), Mst Continus, Oramorph, Sevredol
Italy: Morfina Cloridrato Molteni, Morfina Cloridrato Monico, Morfina Cloridrato S.A.L.F, Morfina Cloridrato S.A.L.F., Ms Contin, Oramorph, Twice
Latvia: Morfīna Hidrohlorīds Kalceks, Vendal Retard
Lithuania: Morphine Hydrochloride Kalceks, Vendal Retard
Luxembourg: Morphine Hcl Sterop, Ms Contin, Ms Direct, Oramorph, Sendolor
Malta: Molnex, Morphine Hydrochloride Monico, Morphine Sulfate As Kalceks
Netherlands: Lunetra, Molnex, Morfine Hcl Cf, Morfine Hcl Expharma, Morfine Hcl Focus, Morfine Hcl Retard Cf, Morfine Hcl Teva, Morfine Kalceks, Morfine Sulphate Aurobindo, Morfinesulfaat Teva, Sendolor
Norway: Malfin, Morfin Abcur, Morfin Epidural, Morfin Orifarm, Relifine
Poland: Autostrzykawka Morfina Przeciwko Bólowi Zpsm Ravimed, Morphine Kalceks, Mst Continus, Oramorph, Sevredol, Vendal Retard
Portugal: Morfina, Mst, Oramorph, Sevredol, Zomorph
Romania: Morfină Zentiva, Sevredol, Vendal Retard
Slovakia: Morphin Bbp, Morphine Kalceks, Mst Continus, Sevredol
Slovenia: Morfin Alkaloid-Int, Oramorph, Sevredol, Substitol
Spain: Morfina B. Braun, Morfina Serra, Mst Continus, Oramorph, Sevredol
Sweden: Depolan, Lacedor, Morfin Abcur, Morfin Alternova, Morfin Kalceks, Morfin Viatris, Morphine Unimedic, Sendolor

EMA – Article 57 product data (EU/EEA), 2026-10-28

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. Morphine Sulfate (Hikma Pharmaceuticals USA Inc.) – Prescribing Information, 2026-02-03. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3c847554-3b4b-4d24-a145-2ef7e9b83699
EMA – Article 57 product data (EU/EEA), 2026-10-28. 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), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
Wikidata (CC0): ATC N02AA.

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.