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Tramadol

Lanalget Retard, Tradolan, Tramabene, Tramadol · ATC code N02AX02

Brand names: Lanalget Retard, Tradolan, Tramabene, Tramadolhydrochlorid Actavis, Tramadolhydrochlorid G.L., Tramadolhydrochlorid Retard Lannacher, Tramadolor, Tramal, Tramastad, Adamon Inject, Adamon Kaps, Adamon Tropfen, Amadol, Nobligan Retard, Tramabeta Long …

Key facts
Active substance
Tramadol
Drug class
Opioid
ATC code
N02AX02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

ADDICTION, ABUSE AND MISUSE

Because the use of tramadol hydrochloride 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 tramadol hydrochloride tablets, especially during initiation or following a dose increase. To reduce the risk of respiratory depression, proper dosing and titration of tramadol hydrochloride tablets are essential [see Warnings and Precautions (5.2)].

ACCIDENTAL INGESTION

Accidental ingestion of even one dose of tramadol hydrochloride tablets, especially by children, can result in a fatal overdose of tramadol [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 tramadol hydrochloride 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)].

ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE- THREATENING RESPIRATORY DEPRESSION IN CHILDREN

Life-threatening respiratory Depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least once case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism [see Warnings and Precautions (5.6)]. Tramadol hydrochloride tablets is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Contraindications (4)]. Avoid the use of tramadol hydrochloride tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol [see Warnings and Precautions (5.6)].

INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES

The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol hydrochloride tablets requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1 [see Warnings and Precautions (5.7); Drug Interactions (7)].

Key facts

Tramadol is an opioid analgesic for adults with pain severe enough to require an opioid and for which alternative treatments are inadequate.

What it is used for

  • Pain in adults severe enough to require an opioid analgesic, when alternatives are inadequate
  • Because of addiction, abuse and overdose risks, reserved for patients in whom alternatives are ineffective, not tolerated or inadequate

Dosing

  • Lowest effective dosage for the shortest duration; not exceeding 400 mg per day
  • Titration: start 25 mg/day, increased every 3 days to 100 mg/day, then to 200 mg/day; thereafter 50 to 100 mg every 4 to 6 hours as needed
  • Where rapid onset is required: 50 mg to 100 mg every four to six hours
  • Severe hepatic impairment: 50 mg every 12 hours
  • Creatinine clearance less than 30 mL/min: dosing interval 12 hours, max 200 mg daily
  • Patients over 75 years old: not more than 300 mg/day

Contraindications

  • Children younger than 12 years; children younger than 18 years after tonsillectomy and/or adenoidectomy
  • Significant respiratory depression; acute or severe asthma in an unmonitored setting
  • Known or suspected gastrointestinal obstruction including paralytic ileus
  • Hypersensitivity to tramadol or opioids
  • Concurrent MAOIs or use within the last 14 days

Important warnings

  • Boxed warning: addiction, abuse and misuse, which can lead to 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, respiratory depression, coma and death
  • Ultra-rapid metabolism in children; serotonin syndrome; seizures; suicide risk
  • Neonatal opioid withdrawal syndrome, adrenal insufficiency, severe hypotension

Side effects

  • Most frequent: dizziness/vertigo, nausea, constipation, headache, somnolence
  • Others: vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhea
  • Serious: respiratory depression, serotonin syndrome, seizures

Interactions

  • CYP2D6 inhibitors: higher tramadol and lower M1 levels; reduced effect or withdrawal possible
  • Benzodiazepines and other CNS depressants only when alternatives are inadequate
  • MAOIs contraindicated; not to be combined with other tramadol-containing products

Pregnancy and breastfeeding

  • Prolonged use in pregnancy may cause neonatal opioid withdrawal syndrome; data on birth defect risk are insufficient

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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Patient information (US)

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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

  • Lanalget RetardG.L. Pharma Gmbh · 1 register entry
  • TradolanG.L. Pharma Gmbh · 3 register entries
  • TramabeneTeva B.V · 3 register entries
  • Tramadol1a Pharma Gmbh · 1 register entry
  • Tramadolhydrochlorid ActavisActavis Group Ptc Ehf. · 2 register entries
  • Tramadolhydrochlorid G.L.G.L. Pharma Gmbh · 3 register entries
  • Tramadolhydrochlorid Retard LannacherG.L. Pharma Gmbh · 1 register entry
  • TramadolorHexal Pharma Gmbh · 3 register entries
  • TramalGrünenthal Österreich Gmbh · 3 register entries
  • TramastadStada Arzneimittel Gmbh · 1 register entry

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

Germany

  • Adamon InjectViatris Healthcare Gmbh · 1 register entry
  • Adamon KapsViatris Healthcare Gmbh · 1 register entry
  • Adamon TropfenViatris Healthcare Gmbh · 1 register entry
  • Amadol123 Acurae Pharma Gmbh, Viatris Healthcare Gmbh · 2 register entries
  • Nobligan RetardGrünenthal Gmbh · 1 register entry
  • Tramabeta LongBetapharm Arzneimittel Gmbh · 1 register entry
  • Tramadol1 A Pharma Gmbh, Aliud Pharma Gmbh, Axcount Generika Gmbh, Libra-Pharm Gmbh, Carinopharm Gmbh, Ratiopharm Gmbh, Stadapharm Gmbh, Ethypharm, Panpharma Gmbh, Aristo Pharma Gmbh (Art 57), Basics Gmbh, Hameln Pharma Gmbh, Viatris Germany Gmbh, Denk Pharma Gmbh & Co. Kg, G.L. Pharma Gmbh, Abz-Pharma Gmbh, Tad Pharma Gmbh · 31 register entries
  • Tramadol/Tramadolhydrochlorid AlAliud Pharma Gmbh · 1 register entry
  • TramadolorHexal Ag · 3 register entries
  • TramagitFairmed Healthcare Gmbh · 1 register entry
  • TramalGrünenthal Gmbh · 5 register entries
  • Travex DirektViatris Healthcare Gmbh · 1 register entry
Show all 13 brand names
  • Travex RetardViatris Healthcare Gmbh · 1 register entry

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

Turkey

  • ContramalABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • ContratekNEUTEC İLAÇ SAN. TİC. A.Ş · 4 register entries
  • MadolKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • RamadexHAVER TRAKYA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • TradolexMENTA PHARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • TramoselHAVER FARMA İLAÇ A.Ş. · 1 register entry
  • TramturkTURK İLAÇ VE SERUM SAN. A.Ş. · 1 register entry
  • UltramexADEKA İLAÇ SAN. VE TİC. A.Ş. · 5 register entries

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

USA

  • ConZipVertical Pharmaceuticals, LLC · 1 register entry

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

Brand names in 27 more European countries
Belgium
Contramal, Tradonal, Tramadol Eg, Tramadol Krka, Tramadol Retard Eg, Tramadol Sandoz, Tramadol Uno Sandoz, Tramium
Bulgaria
Маброн, Трамадол Крка, Трамадол Стада, Трамалгин
Croatia
Awardix, Lumidol, Tramadol Krka, Tramadolor Retard, Tramal
Cyprus
Mabron, Rofy, Tramadex
Czechia
Mabron, Tralgit, Tramabene, Tramadol Krka, Tramadol Sandoz, Tramadol Viatris, Tramadol Vitabalans, Tramal
Denmark
Dolatramyl, Dolol, Gemadol, Mandolgin, Nobligan, Tadol, Tradolan, Tramadol Actavis, Tramadol Krka, Tramadol Retard Actavis, Tramadol Retard Hexal, Tramadol Vitabalans
Estonia
Mabron, Olteron, Tramadol Basi, Tramadol Krka, Tramadol Lannacher, Tramadol Vitabalans
Finland
Tradolan Retard, Tramadol Hexal, Tramadol Krka, Tramadol Retard Hexal, Tramadol Retard Sandoz, Tramadol Vitabalans, Tramal, Tramium
France
Biodalgic, Contramal, L.p., Monocrixo L.P. (Une Prise Quotidienne), Orozamudol, Takadol, Topalgic, Tramadol Almus, Tramadol Arrow, Tramadol Biogaran, Tramadol Eg, Tramadol Evolugen, Tramadol Hcs, Tramadol L.P. Bgr, Tramadol L.P. Evolugen, Tramadol L.P. Sandoz, Tramadol Lp Cristers, Tramadol Lp Krka, Tramadol Lp Viatris, Tramadol Lp Zentiva, Tramadol Lp Zydus, Tramadol Sandoz, Tramadol Teva, Tramadol Unither, Tramadol Viatris, Tramadol Zydus, Zamudol Lp, Zumalgic
Greece
Tramal, Tropium Amp, Τrαμαl
Hungary
Adamon, Contramal, Ralgen, Tramadol Al, Tramadol Kalceks, Tramadol Krka, Tramadol Sopharma, Tramadol Vitabalans, Tramadol Zentiva, Tramadolor
Iceland
Tradolan, Tramadol Actavis, Tramadol Krka, Tramól-L
Ireland
Tradol, Tramadol Hydrochloride Accord Healthcare Ireland, Tramadol Krka, Zydol
Italy
Contramal, Fortradol, Prontalgin, Tradogut, Tradonal S.R., Traflash, Tralodie, Tramadolo Eg, Tramadolo Hcl Sandoz, Tramadolo Hexal, Tramadolo S.A.L.F., Tramalin
Latvia
Mabron, Tramadol Basi, Tramadol Kalceks, Tramadol Krka, Tramadol Lannacher, Tramadol Vitabalans
Lithuania
Mabron, Tramadol Basi, Tramadol Kalceks, Tramadol Krka, Tramadol Lannacher, Tramadol Vitabalans, Tramadolor Id
Luxembourg
Contramal Retard, Tradonal, Tramadol Eg, Tramadol Retard Eg, Tramal, Tramium
Malta
Mabron Retard, Rofy, Tramadol Aurobindo, Tramadol Bristol Laboratories, Tramadol Hydrochloride Accord Healthcare, Tramadol Tad
Netherlands
Tramadol Hcl Cf, Tramadol Hcl Nevik, Tramadol Hcl Retard Duiven, Tramadol Hcl Retard Icc, Tramadol Hcl Retard Prolepha, Tramadol Hcl Retard Teva, Tramadol Hcl Retard Viatris, Tramadol Hcl Sandoz, Tramadol Hcl Viatris, Tramadol Hydrochloride Aurobindo, Tramadolhydrochloride Meda Pharma, Tramal
Norway
Dolatramyl, Nobligan, Tramadol Actavis, Tramadol Hexal, Tramadol Vitabalans, Tramagetic Od, Tramagetic Retard
Poland
Poltram, Tramadol Aurobindo, Tramadol Aurovitas, Tramadol Kalceks, Tramadol Krka, Tramadol Synteza, Tramadol Vitabalans, Tramal
Portugal
Mabron, Paxilfar, Tram-U-Ron Od, Tramadol Aurovitas, Tramadol Azevedos, Tramadol Basi, Tramadol Ciclum, Tramadol Generis, Tramadol Isab, Tramadol Krka, Tramadol Labesfal, Tramadol Medlink, Tramadol Mylan, Tramadol Tad, Tramal, Travex
Romania
Clorhidrat De Tramadol Bioeel, Mabron, Tramacalm, Tramadol, Tramag, Tramal Retard
Slovakia
Adamon Sr, Mabron, Tralgit, Tramabene, Tramadol Krka, Tramadol Retard Actavis, Tramadol Viatris, Tramadol Vitabalans, Tramal
Slovenia
Doloris, Tadol, Tramadol Vitabalans, Tramal
Spain
Adolonta, Captor Simplex, Mabron, Tioner, Tradonal Retard, Tramadol Almus, Tramadol Andrómaco, Tramadol Aristo, Tramadol Asta Medica, Tramadol Aurovitas, Tramadol Basi, Tramadol Cinfa, Tramadol Codramol, Tramadol Farmalider, Tramadol Kern Pharma, Tramadol Krka, Tramadol Mabo, Tramadol Normon, Tramadol Retard Andrómaco, Tramadol Retard Aurovitas Spain, Tramadol Retard Combix, Tramadol Retard Normon, Tramadol Retard Stada, Tramadol Retard Sun, Tramadol Retard Teva-Ratiopharm, Tramadol Retard Viatris, Tramadol Stada, Tramadol Tarbis, Tramadol Teva-Ratiopharm, Tramadol Vir, Zytram
Sweden
Dolatramyl, Tradolan, Tramadol

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.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. tramadol hydrochloride (Strides Pharma Science Limited) – Prescribing Information, 2026-08-27. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a6cbd5de-8ae5-49e3-b89b-e35536b115d8
  2. 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
  3. 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
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC N02AX.

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.