Tramadol

Tramadol was once widely available over the counter and is now prescription-only. The Customs manual classifies tramadol as a controlled medicine for import/export processing and requires DPNA review for controlled-medicine travel cases, but does not establish the ordinary domestic pharmacy dispensing category. Food and Drug circular 2607/D identifies tramadol as prescription-only. Tramadol is not shown as an Anti-Narcotics Law Article 8 named narcotic, but is a controlled medicine with licensing and customs controls. These rules concern lawful, authorized pharmaceutical products; counterfeit, unregistered, smuggled, expired or otherwise non-compliant products are subject to separate requirements.

The current schedule classifies tramadol as a controlled poison. The schedule does not establish a complete dispensing rule or a broader prescription requirement.

The current formulation-specific rule supersedes the 2014 over-the-counter wording; tramadol is subject to special-control restrictions that vary by formulation.

Federally scheduled as of August 18, 2014 under the Controlled Substances Act.¹⁸⁹ Prior to federal scheduling, several states independently controlled tramadol including Arkansas, Illinois, Kentucky, Massachusetts, New York, Oklahoma, and Wyoming. Possession without prescription is illegal.

The ANMAT disposition records prescription-only dispensing; practical over-the-counter availability is not established.

Classified as a Prescription-Only Medicine since 2001 under the Poisons Standard. Requires a valid prescription to obtain legally.

Legal for medical use under the Arzneimittelgesetz (AMG). Possession or sale without a valid prescription is illegal under the Suchtmittelgesetz (SMG).

The schedule establishes controlled circulation but does not itself establish the precise prescription form for every tramadol presentation.

ZODOL (generic TRAMADOL CLORHIDRATO, oral drops) and TRAMADOL CLORHIDRATO (100MG/2ML injectable) are marked RECETA MEDICA in the current official AGEMED medicine registry. The current registry contains no 50 mg tablet record. The LINAME 2022-2024 formulary lists generic Tramadol forms (50 mg tablet, 100 mg/2 ml injectable, and 100 mg/ml oral drops), but a formulary listing does not itself establish sale status. The current AGEMED free-sale workbook does not contain tramadol; this absence does not establish a generic legal classification. AGEMED's controlled-list notice states that the list is updated daily, but its linked T-N-10 PDF is a scan, and AGEMED's manual does not name tramadol. Tramadol is prescription-only for the current authorized products expressly recorded by AGEMED. It is not established whether every possible tramadol salt, formulation, strength, or unregistered product is subject to the same category or to the psychotropic archived-recipe/estupefacient valued-recipe regimes.

Classified under List A2 as a narcotic substance by ANVISA (Agência Nacional de Vigilância Sanitária). Requires prescription and is subject to controlled substance regulations.

The Ministry of Health Department of Drugs and Food formulary lists Tramadol with ‘Schedule: Prescription medicine.’ This listing covers injection 50 mg/mL in a 2 mL ampoule, immediate-release 50 mg tablet, and prolonged-release 50 mg/100 mg tablets, and states that the drug is subject to international control under the Convention on Psychotropic Substances (1961). The formulary's scheduling key says Prescription Medicines should only be obtained with a legally written prescription from a medical doctor; at health-centre level a qualified, properly trained nurse may prescribe medicines included in the Essential Medicines List. The key separately describes Controlled Medicines, but that label appears immediately before the preceding oxycodone entry; it is not the schedule printed after Tramadol. The 2012 Drug Control Law makes dispensing of drugs listed in Tables II and III possible only as medication pursuant to a medical prescription by an authorized physician, dentist, veterinarian, nurse, or midwife, and permits the Minister of Health to authorize limited no-prescription supply only for one or more Table III drugs. The English-law Annex Table II/III text does not name tramadol; it therefore does not establish that tramadol is a Table II or III narcotic or that the narrow Table III exception applies. The current DDF/MOH formulary lists Tramadol as a prescription medicine, independent of its absence from that older Annex. The formulary expressly says it is not a regulatory document or clinical-practice guideline, and the English law translation is unofficial; the Khmer version is authoritative. The cited formulary lists the three named dosage-form/strength groups; combinations, salts, brands, strengths, and other routes may have additional product-specific conditions.

Tramadol, its salts and isomers, and specified derivatives are Schedule I controlled substances under the Controlled Drugs and Substances Act. The Schedule I order and corresponding Narcotic Control Regulations amendment took effect on 31 March 2022. Pharmacists may provide a narcotic only on a practitioner’s signed and dated written prescription, subject to the Regulations; unauthorized possession is prohibited.

Tramadol is listed as a Category II psychotropic substance in China's Catalogue of Narcotic Drugs and Psychotropic Substances (2013 Edition), whose entry covers its salts and single-ingredient preparations. NMPA Announcement No. 43 of 2023 additionally placed compound tramadol preparations in the Category II psychotropic-substances catalogue from 1 July 2023. Under Article 32 of the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances, retail supply of Category II psychotropic substances requires a practising physician's prescription and may not be made without one.

The listed tramadol presentations are subject to strict-prescription labeling.

The current Ministry list has no exact tramadol entry. The absence of an exact tramadol entry in the current Ministry list does not establish that tramadol is unscheduled or freely saleable. Decree 45161-S's special official narcotic/psychotropic prescription forms apply to those categories; the current schedule does not place tramadol there. The official ZALDIAR alert establishes a medical-prescription requirement for one registered paracetamol/tramadol hydrochloride product. Standalone tramadol and other combinations remain subject to their own current sanitary registration, authorized labeling, formulation, concentration and pharmacy-dispensing conditions; the 2019 ZALDIAR statement cannot classify every product.

Tramadol is listed as a controlled substance in Denmark’s Executive Order on euphoriant substances. The Order permits euphoriant substances only for medical or scientific purposes. The Danish Medicines Agency identifies tramadol as a prescription-only analgesic.

Tramadol was listed as controlled since October 2002 and requires a prescription. Despite national control, tramadol remained widely abused, with nearly 70% of people treated at addiction facilities using the drug as of 2015. Decision No. 44 of 2026 replaced the schedules annexed to Law No. 182 of 1960 and states that it operates from publication; its scanned schedule page 21 (PDF page 20) lists Tramadol at item 117 in Table 1 section 2. The EDA's official 12 March 2022 enforcement notice describes seized medicines as 'Schedule I tramadol' listed in the Anti-Narcotics Law. The EDA regulatory index identifies Decision No. 573 of 2024 as the prescription-ticket instrument for dispensing narcotic substances. The official 2026 schedule lists the Tramadol row and chemical description. The relevant scope is limited to Schedule 1 substances and preparations; unregistered products and conduct outside that scope are not addressed.

EFDA expressly classifies tramadol hydrochloride as a narcotic drug, describes it as prescription-only, and requires use under medical supervision. The December 2025 control directive applies to production, import, export, distribution, storage, transport, prescribing, dispensing and use, and its Annex 1/Form NPS/01/A lists Tramadol Hydrochloride as narcotic item 10. A valid supply therefore requires the controlled-medicine prescription and dispensing controls, not ordinary OTC sale. The July 2022 EFDA OTC list describes OTC medicines as legally dispensed without prescription and limits OTC treatment to listed formulations/strengths; tramadol is not listed in that official list. No current Ethiopian numeric Schedule I/II/III/IV designation applies to tramadol; the controlling current category is the EFDA narcotic-medicine classification. Market authorization is product-specific and determined by EFDA's live register. Controlled prescription status is distinct from a numeric international-convention schedule, and practical pharmacy availability does not override the law.

Tramadol Evolugen 50 mg is recorded in the French public medicines database as a medicine supplied only on prescription. French medicines authorities also limit tramadol prescriptions to 12 weeks. Supply is therefore restricted to the prescription-medicine system.

Regulated as a prescription medication according to Anlage 1 AMVV (Arzneimittelverschreibungsverordnung).⁶⁴ Not classified as a narcotic under the BtMG but requires medical authorization.

The official April 2018 notification added Tramadol to the NDPS psychotropic-substance Schedule. Its preamble refers to information and evidence about the substance's nature, effects and scope for abuse. NDPS control is not a categorical ban: section 8(c) permits medical or scientific operations in the manner authorized by the Act, rules, orders and licences/permits. Retail medicinal supply remains prescription-only under Schedule H1, with separate supply-register and labeling requirements. Product formulation, State licensing and specific exceptions are fact-specific.

Tramadol is not available over the counter without a prescription under current Indonesian regulator and Ministry of Health materials. PerBPOM 12/2025 expressly includes active-material tramadol in the OOT regime, while the current medicine rule places hard drugs in the prescription category and limits their dispensing to pharmacists on prescriptions in pharmaceutical-service facilities. BPOM's regional regulator describes tramadol as a hard drug/OOT requiring a doctor's prescription and close expert supervision. OOT distribution and dispensing are limited to health-care and/or scientific purposes, and the regulator warns against free e-commerce/social-media sales and counterfeit products. The official Permenkes 5/2023 tables and the latest narcotics amendment, Permenkes 15/2025, do not name tramadol; opioid pharmacology does not by itself make it an Indonesian narcotic or psychotropic. This legal position concerns ordinary lawful tramadol medicine and does not extend to unregistered, counterfeit, expired, revoked, or otherwise non-compliant products. A registered combination example (ULTRACET) is product-specific and does not authorize every tramadol brand, salt, strength, dosage form, or pack.

Regulated under S.I. No. 540/2003. Legal to possess and use only with a valid prescription from a licensed medical practitioner.

The Ministry of Health’s Decree of 29 July 2022 inserts tramadol itself in Tabella I of the controlled-substances tables under D.P.R. 309/1990. It also adds tramadol medicines to Allegato III-bis and to the Table of Medicines: tramadol as a pure substance and parenteral preparations are in section A, while compositions for non-parenteral administration are in section D. The decree entered into force on 8 November 2022, so medical products are subject to the controlled-medicines prescription rules applicable to their assigned section rather than being freely supplied.

Tramadol is available by prescription only in Japan.

In 2003, tramadol was available over the counter. Tramadol is now within the psychotropic-substances schedule, and pharmacies may dispense it only on a special psychotropic-substances prescription; it is not available over the counter. The operative 2026 placement is Tramadol (ترامادول) in Group Two, Table 4 under Decision No. 165/2026. Product strength, dosage form, combination-product composition, foreign-prescription authentication, and border quantity remain product- and procedure-specific; a foreign prescription or a medicine package does not automatically exempt an import.

Tramadol is listed as an active substance, and the listing covers its medicinal preparations. Products may differ in reimbursement and dispensing conditions. Under the law, a prepared List II substance may be acquired from a pharmacy only on a valid prescription; a prescription does not authorize raw, non-medicinal possession or supply outside the regulated channels.

As of 27 August 2026, Malaysia's current MOH First Schedule expressly places tramadol and its salts in Part I Group B with 'All preparations'. Group B is a controlled-medicine prescription category: ordinary retail sale or supply requires the statutory professional or compliant-prescription pathway, rather than unrestricted over-the-counter access. Tramadol is classified under the Poisons Act as a Group B substance, not as a narcotic under a different instrument. Product legality remains product-specific: manufacture, sale, supply, import, possession and administration of a product generally also require current registration and the appropriate licence, subject to narrow regulatory exceptions. A DCA420 approval-list example does not establish a product's current status; the legality of a particular product depends on its MAL record, composition, holder, indications and current status in NPRA QUEST3+. The separate psychotropic schedule does not establish a general analogue rule.

COFEPRIS records tramadol's 2026 reclassification as a controlled medicine.

Tramadol is listed as a Class C controlled drug in Part 2 of Schedule 3 to the Misuse of Drugs Act 1975. It is therefore supplied through New Zealand's controlled-drug prescription regime. As a controlled opioid, a tramadol prescription is limited to an amount reasonably required for one month of treatment.

Norway added Tramadol to the Narkotikalisten effective 1 September 2020, and the current consolidated list identifies it by CAS 27203-92-5. However, the Tramadol row is not marked 'Forbudt etter § 5'; § 5 prohibition applies to listed entries carrying that reference. Official Helsenorge guidance says a doctor may prescribe tramadol as a stronger analgesic when non-prescription analgesics do not help, and DMP lists Nobligan and Tramagetic as medicines with narcotic active ingredients. Tramadol is prescription-only in Norway; it is a scheduled narcotic substance but is not a § 5-prohibited entry. Authorization or dispensing conditions are not necessarily identical for every formulation, strength, or product.

The Dangerous Drugs Board's latest consolidated list, dated 06 July 2025, contains no TRAMADOL, tramadol or tramadol hydrochloride entry in the 1961 narcotic, 1971 psychotropic or Philippine Schedule table. Because tramadol is absent from those schedules, ordinary tramadol is not established as a Philippine dangerous drug solely because FDA records call it an opioid analgesic; this absence does not affirmatively authorize possession, use, importation, sale or unregistered/counterfeit products. RA 10918 section 5(rr) defines prescription/ethical medicines as medicines dispensed by a pharmacist only upon a valid physician, dentist or veterinarian prescription. The official FDA portal lists Saphtram (DRP-3942; tramadol hydrochloride 50 mg capsule) and Pyredol (DRP-3309; tramadol hydrochloride/paracetamol 37.5/325 mg tablet) as Prescription Drug (RX); their expiry, registration and approved labeling are unspecified. The legal treatment of each tramadol formulation, injectable product, combination, import and online offer may differ. These requirements do not necessarily apply to any other active ingredient, analogue, derivative or isomer, and may change with a later DDB reclassification.

The 200 mg prolonged-release presentation is prescription-only; exact dispensing category can vary by product presentation.

INFOMED is presentation-specific: the Tramadol Aurovitas 50 mg capsule record is marketed and classified as a medicine subject to prescription; other strengths, forms, combinations or pack sizes are classified individually. Personal-drug possession has been decriminalized since 2001 under a separate controlled-drug possession regime; this does not establish the dispensing classification of a marketed tramadol medicine. Tramadol does not appear in the current controlled-substance tables under Decreto-Lei n.º 15/93, but that schedule result is distinct from MSRM status.

The official label identifies tramadol hydrochloride 50 mg in the PS prescription-only dispensing category; tramadol is not available without a prescription.

Tramadol is dispensed by prescription only and is not available over the counter. The Antalgex T SmPC is internally inconsistent: its distribution section contains both 'Over-the counter medicine / List I' and 'Prescription only medicines'. The conflicting entries indicate prescription controls, but the SmPC does not provide an unqualified standalone label. The Rwanda FDA register lists an authorized tramadol-containing product, but this does not establish OTC sale or resolve narcotic scheduling.

Tramadol is classified in Schedule 5; sale and ordinary personal possession without the required prescription are not decriminalized or limited to a misdemeanor. Section 22A(5)(b) requires Schedule 5 sale through a pharmacist (or supervised pharmacist's assistant/intern) on a written prescription or qualifying verbal instruction; section 22A(16)(b) expressly limits ordinary personal possession of Schedule 5 to a person holding an authorised prescription. Contravention of section 22A is an offence under section 29(k), punishable under section 30(1) by a fine or imprisonment up to 10 years. For Schedule 5 analgesic use, a new prescription after six months requires consultation with another medical practitioner; repeats require the prescriber to state the number and intervals, and emergency verbal supply is limited to 48 hours with written confirmation within 72 hours. Schedule 5 sales require permanent prescription-book/record entries and five-year retention under regulation 35. Product-specific registration, dosage/strength/route, licensing, and any later Gazette amendment remain separate questions.

Launched in 1992 and was one of the only opioids not requiring special prescription forms. Usage increased significantly from 2.1 to 570.6 defined daily doses per million people per day between 1992 and 1998.

The Ordinance permits medical practitioners to prescribe or supply a dangerous drug for treatment, limits a patient supply to a three-day amount, and permits a pharmacist on premises licensed by the Director to supply it on a medical, dental or veterinary prescription. Unauthorized possession, sale, supply or use remains an offence. Penalties depend on the conduct and quantity: the general penalty in §78 is stated below, while §54A and the Third Schedule Part III quantity table can apply to trafficking, possession, import or export above the statutory thresholds. The 2026 amendment, certified 6 March 2026, adds a high-seas offence and updates cross-references; it does not amend tramadol's item 126 listing or the ordinary prescription provisions.

In Sweden, tramadol is available for medical use by prescription only.

Tramadol is classified in category A under Swissmedic's 18 December 2024 notice.

The Ministry list (İY.LS.16, revision 7, revised 30 July 2025) specifically contains TRAMADOL HCL and named products, including Contramal, Ultramex, Contramal Retard, Contratek, Madol, Ramadex, Tradolex, Tramosel, Tramturk and oral-drop/injection forms. TİTCK Genelge 2016/3 says green prescriptions are used for psychotropic medicines, limits a green prescription to at most two boxes containing the same active ingredient unless the specified specialist report supports more, requires the physician and pharmacist fields, and prohibits repeating red or green prescriptions; it also says medicines outside the published lists must not be written or dispensed. A valid prescription therefore makes lawful medicinal dispensing possible, while unprescribed retail sale is not permitted. For criminal exposure, TCK Art. 188(6) extends the Art. 188 rules to substances producing narcotic or stimulant effects whose sale requires an authorized physician prescription. Under the statutory text, unauthorized in-country selling, offering, giving, dispatching, transporting, storing, buying, accepting or possessing a covered substance carries at least 10 years' imprisonment and 1,000-20,000 days' judicial fine under Art. 188(3), while unauthorized manufacture/import/export carries 20-30 years and 2,000-20,000 days under Art. 188(1). TCK Art. 191 separately provides 2-5 years for buying, accepting, possessing or using for personal use, with a five-year deferred-prosecution and supervised-release framework; classification between Arts. 188 and 191 is fact-specific and a lawful prescription is not the same as unauthorized possession. The official controlled-medicine list is dated 30 July 2025, and the Ministry of Justice consolidation was uploaded 23 June 2025 and includes the 2023 Law 7445 changes. The official TBMM record lists Law 7571 as accepted on 24 December 2025 and published in Official Gazette 33118 on 25 December 2025. The cited Arts. 188/191 ranges were not changed by those amendments. The requirements for a particular prescription depend on product-specific licensing and the applicable list revision.

Tramadol is listed in Table II, List No. 1 of Ukraine's national list of narcotic drugs, psychotropic substances, and precursors. It is supplied for medical indications through the controlled narcotic-medicines system, including electronic prescriptions and licensed pharmacies.

Tramadol is listed as a Controlled Drug (CD) on UAE's official EDE list, and EDE's current personal-import service permits medically authorized use/import with the required prescription or medical report. Travelers may carry no more than the patient's need for a maximum three months; prior electronic approval is optional for travelers, but the prescription/medical report must be carried and authenticated by the relevant health authority. Residents importing personal narcotic or psychotropic medicines must apply electronically. The Official Platform of the UAE Government page, updated 16 July 2026, states that Federal Decree by Law No. 30 of 2021 criminalizes production, import, export, transport, buying, selling, possessing and storing narcotic and psychotropic substances unless undertaken as supervised and regulated medical or scientific activity. Current UAE government guidance does not state a universal four-year sentence for tramadol. Exact sentencing for unauthorized possession, import, supply or use is offense- and circumstance-specific and must not be inferred from the EDE travel allowance. The EDE list itself records a 15 September 2022 update, so its date is disclosed even though the list remains linked from the current EDE service page.

Classified as a Class C drug under the Misuse of Drugs Act as of June 10, 2014.¹⁸⁸ Previously available as a prescription-only medicine without controlled substance status. Annual tramadol-related deaths declined following scheduling.