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Thalidomide

Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed · ATC code L04AX02

Also known as: Thalidomid

Key facts
Active substance
Thalidomide
Drug class
Immunosuppressive drug
ATC code
L04AX02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Thalidomide BMS 50 mg hard capsules · Thalidomide Lipomed 100 mg coated tablets
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG, Lipomed GmbH
Information as of
2026-10-27

Key facts

Thalidomide is an immunomodulatory agent used first line with melphalan and prednisone for untreated multiple myeloma; it is a powerful human teratogen.

What it is used for

  • First-line treatment of untreated multiple myeloma in combination with melphalan and prednisone
  • In patients aged ≥ 65 years or ineligible for high-dose chemotherapy
  • Prescribed and dispensed only under the Pregnancy Prevention Programme

Dosing

  • Recommended dose: 200 mg daily at bedtime, for a maximum of 12 cycles of 6 weeks (42 days)
  • Patients over 75 years: starting dose 100 mg daily
  • Thalidomide Lipomed contains 100 mg per tablet, whereas other products usually contain 50 mg; this must be taken into account
  • Dose delay, reduction or discontinuation depending on toxicity grade
  • Missed dose: take if less than 12 hours late, otherwise skip
  • Thromboprophylaxis for at least the first 5 months

Contraindications

  • Hypersensitivity to thalidomide or any excipient
  • Women who are pregnant
  • Women of childbearing potential unless all Pregnancy Prevention Programme conditions are met
  • Male patients unable to comply with the required contraceptive measures

Important warnings

  • Powerful human teratogen causing severe, life-threatening birth defects; Pregnancy Prevention Programme for all patients
  • Thromboembolic events (deep vein thrombosis, pulmonary embolism)
  • Peripheral neuropathy
  • Severe skin reactions (SJS, TEN, DRESS)
  • Bradycardia, syncope, somnolence, neutropenia and thrombocytopenia

Side effects

  • Most common (with melphalan/prednisone): neutropenia, leukopenia, constipation, somnolence, paraesthesia, peripheral neuropathy, anaemia, thrombocytopenia, dizziness, tremor, peripheral oedema
  • Most clinically important: deep vein thrombosis, pulmonary embolism, peripheral neuropathy, severe skin reactions, syncope, bradycardia

Interactions

  • Enhanced sedation with anxiolytics, hypnotics, antipsychotics, H1 antihistamines, opiates, barbiturates and alcohol
  • Caution with bradycardic drugs (e.g. beta blockers, anticholinesterase agents)
  • Low potential for CYP450 interactions

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; women of childbearing potential must use effective contraception from at least 4 weeks before, during and until at least 4 weeks after treatment
  • If pregnancy occurs, treatment must be stopped immediately

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 →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Germany

  • Thalidomid ZentivaZentiva Pharma Gmbh · 1 register entry

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

Turkey

  • Thalidomide BmsBRISTOL-MYERS SQUIBB İLAÇLARI INC. İSTANBUL ŞUBESİ · 1 register entry

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

Brand names in 15 more European countries
Cyprus
Thalidomide Accord
Denmark
Thalidomid Accord, Thalidomide Zentiva
France
Thalidomide Accord, Thalidomide Koanaa
Hungary
Thalidomide Accord
Iceland
Thalidomide Bms
Italy
Talidomide Accord, Talidomide Aurobindo, Talidomide Koanaa
Liechtenstein
Thalidomide Bms
Malta
Thalidomide Accord
Netherlands
Thalidomide
Norway
Thalidomide Bms, Thalidomide Zentiva
Portugal
Talidomida Accord, Talidomida Generis, Talidomida Koanaa
Romania
Talidomidă Accord
Slovenia
Talidomid Accord
Spain
Taliodmida Accord
Sweden
Thalidomide Zentiva

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

  1. European Medicines Agency. Thalidomide BMS (previously Thalidomide Celgene) – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/thalidomide-bms-epar-product-information_en.pdf
  2. European Medicines Agency. Thalidomide Lipomed – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/thalidomide-lipomed-epar-product-information_en.pdf
  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. Wikidata (CC0): ATC L04AX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.