Thalidomide

Pronunciation: pronunciation varies by local usage.

Generic name
Thalidomide
Brand names
Thalomid
Drug class
Immunomodulatory agent

Availability and supply rules vary by country

Trade names by country: United States · Canada

Australia: · Full directory

What Thalidomide is and how it works

Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.

What Thalidomide is used for

Newly diagnosed multiple myeloma

Used in combination with dexamethasone.

Erythema nodosum leprosum (ENL)

Acute treatment of cutaneous manifestations of moderate-to-severe ENL, and maintenance therapy to prevent/suppress recurrence.

Before taking Thalidomide

Do not take / not appropriate for

  • Do not take thalidomide if you are pregnant. Pregnancy is an absolute contraindication. Thalidomide is a powerful human teratogen: even a single dose taken during pregnancy can cause severe, life-threatening birth defects or death of the unborn baby. (all countries)
  • Do not take thalidomide if you have ever had a hypersensitivity (allergic) reaction to thalidomide or to any of its components. (all countries)
  • Do not take thalidomide unless it is supplied through the restricted THALOMID REMS pregnancy-prevention programme. Because of the risk to an unborn baby, the medicine is available in the US only through that programme. (United States)
  • Females who could become pregnant must not take thalidomide unless they either abstain continuously from heterosexual intercourse or use two reliable methods of birth control at the same time — starting 4 weeks before the first dose, throughout treatment, during any break in dosing, and for 4 weeks after the last dose. (all countries)
  • Females who could become pregnant must not start thalidomide without two negative pregnancy tests: the first 10 to 14 days before treatment and the second within 24 hours before the medicine is prescribed. Testing then continues weekly for the first month, and after that monthly if menstrual cycles are regular or every 2 weeks if they are irregular. (all countries)
  • Males taking thalidomide must not have sexual contact with a female who could become pregnant without using a latex or synthetic condom every time — while taking thalidomide and for up to 4 weeks after the last dose, even after a successful vasectomy — because thalidomide is present in semen. Males taking thalidomide must not donate sperm. (all countries)
  • Do not donate blood while taking thalidomide or for 4 weeks after the last dose, because the blood could be given to a pregnant patient whose unborn baby must not be exposed to thalidomide. (all countries)

Tell your clinician about

  • If there is any chance at all that you are pregnant, or if you miss a period, stop thalidomide immediately and contact your clinician.
  • Which two methods of contraception you are using, and whether either has failed or been missed.
  • Any history of blood clots in the legs or lungs: the boxed warning states that thalidomide, particularly with dexamethasone, increases the risk of venous thromboembolism (22.5% with thalidomide plus dexamethasone versus 4.9% with dexamethasone alone).
  • Any heart disease, previous heart attack, or stroke — ischaemic heart disease and stroke have been observed with thalidomide plus dexamethasone.
  • Any drowsiness or sleepiness, and any numbness or tingling in the hands or feet.
  • Every other medicine you take, including any that cause drowsiness.
  • Breastfeeding, or plans to breastfeed.

How to take Thalidomide

  • General Instructions: Take thalidomide exactly as prescribed under the mandatory THALOMID REMS program, which includes required pregnancy testing and contraception counseling for anyone who could become pregnant.. When To Seek Review: Seek medical attention immediately for leg swelling/pain, chest pain, shortness of breath, or any sign of pregnancy.. Storage: Store at room temperature, away from moisture and heat, out of reach of children, in the original REMS-dispensed packaging.

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician.

Missed dose

If you miss a dose, contact your prescriber for guidance rather than deciding on your own.

Overdose

In case of overdose, seek emergency medical attention immediately.

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Drowsiness (somnolence)

What to notice: A common side effect, often more noticeable early in treatment.

What to do: Avoid driving or operating machinery until you know how thalidomide affects you. (2)

Constipation

What to notice: A common side effect.

What to do: Contact your prescriber if severe or persistent; they may advise dietary or medication measures. (2)

Tingling or numbness in hands or feet (peripheral neuropathy)

What to notice: Can develop with treatment and may not be fully reversible.

What to do: Contact your prescriber promptly if you notice new tingling, numbness, or weakness. (2)

Serious warnings

Severe birth defects (teratogenicity) —

Action: Boxed warning: thalidomide causes severe, life-threatening birth defects, even after a single dose, and is contraindicated in pregnancy. Only available through the restricted THALOMID REMS program, which requires pregnancy testing and contraception verification for anyone who could become pregnant. If you are or may become pregnant, contact your prescriber immediately — never take this medicine without REMS enrollment.

Blood clots (deep vein thrombosis, pulmonary embolism) —

Action: Seek immediate medical attention for leg swelling/pain, chest pain, or shortness of breath.

Allergic reaction —

Action: Seek immediate medical attention for swelling, difficulty breathing, or severe rash.

Interactions

Medicine or testEffectAction
Other sedating medicinesMay add to thalidomide’s drowsiness.Discuss with your prescriber before combining. (2)
Hormonal contraceptivesREMS-mandated dual contraception is required for anyone who could become pregnant; discuss the specific contraceptive plan with your prescriber.Follow the THALOMID REMS program requirements exactly. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Thalidomide is contraindicated in pregnancy — it is a powerful human teratogen causing severe birth defects even after one dose. The mandatory THALOMID REMS program requires pregnancy testing and strict contraception for anyone who could become pregnant; a pregnancy exposure registry monitors outcomes.

Breastfeeding

Requires a primary-source research pass before this section can be completed.

Children

Requires a primary-source research pass before this section can be completed.

Renal_impairment

Requires a primary-source research pass before this section can be completed.

Hepatic_impairment

Requires a primary-source research pass before this section can be completed.

Monitoring

Storage

Follow the exact product label and keep medicines away from children.

Clinician-facing summary

Clinician-facing context only.

General

Indication: Newly diagnosed multiple myeloma

Dose summary: For multiple myeloma with dexamethasone: commonly 200 mg once daily, set and monitored under the mandatory THALOMID REMS program. For ENL: dosing individualized by the treating specialist based on severity.

Renal context: No specific renal dose-adjustment guidance was found in the sources reviewed; use in renal impairment requires specialist assessment. (2)

Frequently asked questions

What is Thalidomide used for?

Thalidomide is used, in combination with dexamethasone, to treat newly diagnosed multiple myeloma, and to treat or prevent the skin manifestations of erythema nodosum leprosum (ENL), a complication of leprosy.

What are the side effects of Thalidomide?

Common side effects include drowsiness, constipation, and tingling in the hands or feet. Thalidomide causes severe, life-threatening birth defects even after a single dose and is contraindicated in pregnancy — it is only available through the strict THALOMID REMS program with mandatory pregnancy testing and contraception. Seek immediate medical attention for leg swelling/pain or chest pain (possible blood clot).

How should I take Thalidomide?

Take thalidomide exactly as prescribed, only while enrolled in the mandatory THALOMID REMS program, which requires pregnancy testing and contraception counseling for anyone who could become pregnant. Never take this medicine outside the REMS program.

What is the generic name of Thalidomide?

The generic name is Thalidomide. It is sold under brand names including Thalomid.

What class of drug is Thalidomide?

Thalidomide is classed as: Immunomodulatory agent.

References

  1. Thalidomide — Prescribing InformationDailyMed (U.S. National Library of Medicine) — mirrored on MedGuideGlobal · United States · accessed null · source 1
  2. THALOMID (thalidomide) capsule — Prescribing Information (DailyMed)DailyMed / authoritative reference · United States · accessed 2026-08-08 · source 2
  3. THALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
  4. Thalidomide — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
  5. Thalomid — FDA approval record (Drugs@FDA NDA020785)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 5
  6. Thalidomide — RxNorm normalized drug concept (RXCUI 10432)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 6

Brand names by country

Single-ingredient Thalidomide names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Thalomid50 mg, 100 mg, 150 mg, 200 mg · celgene corporation

Canada

  • THALOMID
View brands in additional countries.