Thalomid (thalidomide)
An approved treatment for Multiple Myeloma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Thalidomide wherever you encounter it, plus the key facts at a glance.
- Generic name
- Thalidomide
- Brand name
- Thalomid
- Drug class
- Immunomodulatory drug (IMiD)
- Manufacturer
- Bristol Myers Squibb (Thalomid is a trademark of Celgene Corporation, a Bristol Myers Squibb company)
- How it's taken
- A capsule taken by mouth once a day at bedtime, with dexamethasone, in 28-day cycles
Thalomid (thalidomide) is an immunomodulatory pill, taken with the steroid dexamethasone, for people with newly diagnosed multiple myeloma[1].
- The FDA approved Thalomid for newly diagnosed myeloma on May 25, 2006, after first approving it in 1998 for a complication of leprosy[2].
- In the label's larger myeloma trial, the median time until the disease worsened was 97.7 weeks with Thalomid and dexamethasone against 28.3 weeks with placebo and dexamethasone[1].
- Thalomid carries a boxed warning for severe birth defects and for blood clots, and it is only available through the Thalidomide REMS program[1].
- Thalomid is approved for myeloma only in combination with dexamethasone, and the label lists no myeloma use on its own[1].
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Where Thalidomide fits
The label limits Thalomid's myeloma use to people with newly diagnosed multiple myeloma, in combination with dexamethasone[1]. The label does not list a myeloma use for Thalomid on its own or for relapsed disease[1]. Its other approved use is the skin symptoms of erythema nodosum leprosum, a complication of leprosy[1].
How Thalidomide works
The label says the way Thalomid works is not fully understood[1]. Its effects inside cells run through a protein called cereblon, part of the cell's machinery for tagging proteins to be broken down[1].
The label describes 3 kinds of activity[1]:
- Immune effects: in people with myeloma, treatment raised the number of natural killer cells, immune cells that attack abnormal cells, and raised levels of the immune signals interleukin-2 and interferon-gamma[1].
- Anti-inflammatory effects: thalidomide may lower excess tumor necrosis factor-alpha (TNF-alpha), an inflammatory signal, although results vary by condition[1].
- Anti-angiogenic effects: in lab studies, thalidomide blocked the growth of new blood vessels, which tumors need to grow[1].
Thalidomide is not processed by the liver's cytochrome P450 enzymes, and the label does not expect drug interactions through that pathway[1].
Side effects and safety
- Birth defects. Not for use in pregnancy. Negative results on 2 pregnancy tests are needed before starting, and 2 reliable birth control methods from 4 weeks before until 4 weeks after treatment, or continuous abstinence from heterosexual sex.
- Thalidomide REMS. Prescribers and pharmacies must be certified, and patients must sign a Patient-Physician Agreement Form and follow pregnancy testing and contraception rules.
- Blood clots, heart attack and stroke. Vein clots in 22.5% on Thalomid with dexamethasone against 4.9% on dexamethasone alone in 1 trial; ischemic heart disease and stroke were also more common.
- Deaths with pembrolizumab. Adding pembrolizumab to a thalidomide-type drug and dexamethasone increased deaths in 2 myeloma trials.
- Drowsiness. Frequent; the label advises avoiding driving or dangerous tasks when drowsy and other sedating medicines without medical advice.
- Peripheral neuropathy. Nerve damage that may be permanent; checked monthly for the first 3 months and periodically after.
- Dizziness on standing. Sitting upright for a few minutes before standing up is advised.
- Low white cells and platelets. Treatment should not start with neutrophils below 750/mm3; counts are monitored and doses may be paused or lowered.
- Slow heartbeat. Some cases needed medical treatment; heart rate and fainting are monitored.
- Severe skin reactions. Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS have been reported and can be fatal.
- Seizures. Reported after approval, mostly in people already prone to seizures.
- Tumor lysis syndrome. People with a high tumor burden are watched for rapid breakdown of cancer cells.
- Allergic reactions. Angioedema and anaphylaxis have been reported; Thalomid is not restarted after either.
- Higher HIV viral load. Seen in a trial in people with HIV; viral load is checked after months 1 and 3 and every 3 months.
- Pregnancy tests before starting, weekly in the first month, then monthly (every 2 weeks with irregular cycles)
- Blood counts, including white cells and platelets
- Nerve checks monthly for the first 3 months, then periodically
- Signs of blood clots such as shortness of breath, chest pain or arm or leg swelling
- Heart rate and fainting
- HIV viral load in people with HIV
Thalomid has a boxed warning, the FDA's strongest label warning, for 2 risks[1]:
- Birth defects: a single capsule taken during pregnancy can cause severe birth defects or death of the unborn baby, and Thalomid must never be used by anyone who is or could become pregnant while taking it[1].
- Blood clots: in myeloma, Thalomid with dexamethasone sharply raises the risk of clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism)[1].
In 1 controlled trial, clots in the veins occurred in 22.5% on Thalomid and dexamethasone against 4.9% on dexamethasone alone[1]. In another, ischemic heart disease occurred in 11.1% on Thalomid and dexamethasone against 4.7% on placebo and dexamethasone, and stroke in 2.6% against 0.9%[1]. The label advises considering clot-preventing medicine based on each person's risk factors[1].
Nerve damage in the hands and feet (peripheral neuropathy) is common, can be severe, and may be permanent[1]. Symptoms can begin after Thalomid is stopped and may resolve slowly or not at all[1]. Thalomid often causes drowsiness, and it can cause dizziness when standing up, a slow heartbeat, low white cell and platelet counts, and serious skin reactions such as Stevens-Johnson syndrome and DRESS[1].
In the larger myeloma trial (Study 2), constipation affected 50% on Thalomid and dexamethasone against 21% on placebo and dexamethasone[1]. Tremor affected 26% against 12%, and deep vein thrombosis 13% against 2%[1]. Side effects led 37% of people on Thalomid and dexamethasone to stop treatment, against 15% on placebo and dexamethasone[1].
The label also warns that adding pembrolizumab, a PD-1 blocking antibody, to a thalidomide-type drug and dexamethasone increased deaths in 2 myeloma trials[1]. That combination is not recommended outside controlled clinical trials[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Thalidomide
Thalomid is a capsule taken by mouth with water, preferably at bedtime and at least 1 hour after the evening meal[1].
For newly diagnosed myeloma, the label's dosing is[1]:
Thalomid is paused for constipation, drowsiness or nerve damage, and a lower dose may be used when it restarts[1]. It is stopped for good after angioedema, anaphylaxis or severe skin reactions[1]. Capsules come in 50mg, 100mg, 150mg and 200mg strengths and are kept in their blister packs until taken[1]. Capsules should not be opened or crushed, and skin that touches the powder is washed with soap and water[1].
Thalomid is only available through the Thalidomide REMS program, a restricted program because of the risk of birth defects[1]. Prescribers and pharmacies must be certified, and patients sign a Patient-Physician Agreement Form and follow its pregnancy testing and contraception rules[1]. The label lists www.thalidomideremsprogram.com and the REMS Call Center at 1-888-423-5436[1]. Patients must not donate blood during treatment or for 4 weeks after, and male patients must not donate sperm[1].
Availability and cost
Only available as the brand-name product.
Help paying for Thalomid
With private insurance, the drugmaker's copay card can lower what you pay for Thalomid. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 5 charity funds for Multiple Myeloma, 1 was open on October 26, 2026. Pick your insurance below to see which offers fit you.
- Copay help
The BMS Access Support Co-Pay Assistance Program helps commercially insured patients prescribed Thalomid with out-of-pocket deductibles, co-pays or co-insurance. Eligible patients may pay as little as $0 per one-month supply, subject to a maximum benefit; restrictions apply.
For: private insurance · source - Other support
People with government insurance such as Medicare, Medicaid or TRICARE are not eligible for BMS co-pay programs. BMS Access Support may provide information about, or refer uninsured patients to, independent charitable foundations.
For: Medicare, Medicaid, TRICARE, no insurance · source - Insurance and case manager help
BMS Access Support offers coverage and access assistance and help finding local support resources. Live support at 1-800-861-0048, 8 am to 8 pm ET, Monday to Friday.
The official page does not say who qualifies. Ask the program. · source
Good to know: The co-pay page does not publish the dollar amount of the maximum benefit; full eligibility rules are in the BMS orals Terms and Conditions. Charitable foundations are independent of Bristol Myers Squibb and set their own rules. Thalomid is dispensed only by pharmacies certified in the Thalidomide REMS program. The program covers brand Thalomid; generic thalidomide from other makers is not part of it.
Charity funds for Multiple Myeloma
- From a charity · HealthWell FoundationMultiple Myeloma (Medicare Access) fundOpen
Pays for: Copays, premiums or other treatment costs. Medicare patients only.
Clinical trial results
The label describes 2 randomized trials in people with newly diagnosed myeloma[1].
Study 1 was an open-label trial of 207 people given Thalomid and dexamethasone or dexamethasone alone for 4 cycles of 28 days[1]. Response, measured by the myeloma protein in blood or urine, was 52% with Thalomid and dexamethasone against 36% with dexamethasone alone[1].
Study 2 (THAL-MM-003, NCT00057564) was a double-blind trial that randomized 470 people to Thalomid and dexamethasone or placebo and dexamethasone, with treatment continuing until the disease progressed[1][3]. Results from a planned interim analysis on the label[1]:
At that analysis, 24% on Thalomid and dexamethasone and 29% on placebo and dexamethasone had died, and median survival had not been reached in the Thalomid group[1]. The survival hazard ratio was 0.82, with a confidence interval that included no difference[1].
Development history
The current Thalomid label calls thalidomide a powerful human teratogen, a drug that causes birth defects, and that risk is why it is sold only through a restricted program[1].
FDA approval history for Thalomid[2]:
- July 16, 1998: first approval, for erythema nodosum leprosum (ENL), a painful inflammatory complication of leprosy[2][1].
- May 25, 2006: accelerated approval with dexamethasone for newly diagnosed multiple myeloma[2][6].
- August 3, 2010: the FDA approved the REMS safety program, then called the Thalomid REMS[7].
- February 3, 2012: the FDA approved a label update adding results from THAL-MM-003, 1 of 2 postmarketing commitments set at the accelerated approval[6].
- September 2, 2026: the FDA approved renaming it the Thalidomide REMS and turning it into a shared program for all thalidomide makers, with a new web address[7].
Thalomid is still approved for ENL skin symptoms, but this page covers only its myeloma use[1]. Bristol Myers Squibb holds the Thalomid application and markets the drug, and Thalomid is a trademark of Celgene Corporation, a Bristol Myers Squibb company[1][2]. The FDA gave final approval to a generic thalidomide from Natco Pharma, with Teva as its U.S. agent, for the 150mg capsule on April 27, 2023 and for the other strengths on April 24, 2026[8].
Explore Multiple Myeloma trials
Other Multiple Myeloma treatments
Thalomid belongs to the immunomodulatory drug family used in myeloma, which also includes lenalidomide (Revlimid) and pomalidomide (Pomalyst), both described on their labels as thalidomide analogues[4][5]. The Thalomid label rests on trials against dexamethasone alone or with placebo, not head-to-head trials against other immunomodulatory drugs, so it does not show one is better than another[1]. A care team weighs these options with each person's health and treatment goals.
Common questions about Thalidomide
▸What is Thalidomide (Thalomid)?
Thalomid (thalidomide) is an immunomodulatory pill, taken with the steroid dexamethasone, for people with newly diagnosed multiple myeloma[1]. The FDA approved Thalomid for newly diagnosed myeloma on May 25, 2006, after first approving it in 1998 for a complication of leprosy[2]. In the label's larger myeloma trial, the median time until the disease worsened was 97.7 weeks with Thalomid and dexamethasone against 28.3 weeks with placebo and dexamethasone[1]. Thalomid carries a boxed warning for severe birth defects and for blood clots, and it is only available through the Thalidomide REMS program[1]. Thalomid is approved for myeloma only in combination with dexamethasone, and the label lists no myeloma use on its own[1].
▸How does Thalidomide work?
The label says the way Thalomid works is not fully understood[1]. Its effects inside cells run through a protein called cereblon, part of the cell's machinery for tagging proteins to be broken down[1].
The label describes 3 kinds of activity[1]:
- Immune effects: in people with myeloma, treatment raised the number of natural killer cells, immune cells that attack abnormal cells, and raised levels of the immune signals interleukin-2 and interferon-gamma[1].
- Anti-inflammatory effects: thalidomide may lower excess tumor necrosis factor-alpha (TNF-alpha), an inflammatory signal, although results vary by condition[1].
- Anti-angiogenic effects: in lab studies, thalidomide blocked the growth of new blood vessels, which tumors need to grow[1].
Thalidomide is not processed by the liver's cytochrome P450 enzymes, and the label does not expect drug interactions through that pathway[1].
▸What are the side effects of Thalidomide?
Thalomid has a boxed warning, the FDA's strongest label warning, for 2 risks[1]: Birth defects: a single capsule taken during pregnancy can cause severe birth defects or death of the unborn baby, and Thalomid must never be used by anyone who is or could become pregnant while taking it[1]. Blood clots: in myeloma, Thalomid with dexamethasone sharply raises the risk of clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism)[1].
In 1 controlled trial, clots in the veins occurred in 22.5% on Thalomid and dexamethasone against 4.9% on dexamethasone alone[1]. In another, ischemic heart disease occurred in 11.1% on Thalomid and dexamethasone against 4.7% on placebo and dexamethasone, and stroke in 2.6% against 0.9%[1]. The label advises considering clot-preventing medicine based on each person's risk factors[1].
Nerve damage in the hands and feet (peripheral neuropathy) is common, can be severe, and may be permanent[1]. Symptoms can begin after Thalomid is stopped and may resolve slowly or not at all[1]. Thalomid often causes drowsiness, and it can cause dizziness when standing up, a slow heartbeat, low white cell and platelet counts, and serious skin reactions such as Stevens-Johnson syndrome and DRESS[1].
In the larger myeloma trial (Study 2), constipation affected 50% on Thalomid and dexamethasone against 21% on placebo and dexamethasone[1]. Tremor affected 26% against 12%, and deep vein thrombosis 13% against 2%[1]. Side effects led 37% of people on Thalomid and dexamethasone to stop treatment, against 15% on placebo and dexamethasone[1].
The label also warns that adding pembrolizumab, a PD-1 blocking antibody, to a thalidomide-type drug and dexamethasone increased deaths in 2 myeloma trials[1]. That combination is not recommended outside controlled clinical trials[1].
▸How is Thalidomide taken?
Thalomid is a capsule taken by mouth with water, preferably at bedtime and at least 1 hour after the evening meal[1].
For newly diagnosed myeloma, the label's dosing is[1]:
- Thalomid: 200mg once a day in 28-day cycles[1].
- Dexamethasone: 40mg by mouth once a day on days 1 to 4, 9 to 12 and 17 to 20 of each 28-day cycle[1].
Thalomid is paused for constipation, drowsiness or nerve damage, and a lower dose may be used when it restarts[1]. It is stopped for good after angioedema, anaphylaxis or severe skin reactions[1]. Capsules come in 50mg, 100mg, 150mg and 200mg strengths and are kept in their blister packs until taken[1]. Capsules should not be opened or crushed, and skin that touches the powder is washed with soap and water[1].
Thalomid is only available through the Thalidomide REMS program, a restricted program because of the risk of birth defects[1]. Prescribers and pharmacies must be certified, and patients sign a Patient-Physician Agreement Form and follow its pregnancy testing and contraception rules[1]. The label lists www.thalidomideremsprogram.com and the REMS Call Center at 1-888-423-5436[1]. Patients must not donate blood during treatment or for 4 weeks after, and male patients must not donate sperm[1].
▸Is Thalidomide FDA approved?
Yes, Thalidomide (Thalomid) is FDA approved (2006) for the treatment of Multiple Myeloma.
▸Is thalidomide still used for multiple myeloma?
Yes, Thalomid (thalidomide) is FDA-approved with dexamethasone for people with newly diagnosed multiple myeloma[1].
Approved since: The FDA approved this myeloma use on May 25, 2006[2].
Label updated: The label was last revised in September 2026, when the REMS program was renamed[1][7].
Generic: The FDA has approved a generic thalidomide from Natco Pharma[8].
Source: Thalomid prescribing information (FDA, September 2026); Drugs@FDA, NDA 020785
▸Is Thalomid chemotherapy?
The Thalomid label does not call it chemotherapy; it describes thalidomide as an immunomodulatory agent with immune-modulating, anti-inflammatory and anti-angiogenic properties[1].
Target: Its effects in cells run through a protein called cereblon[1].
Given with: For myeloma it is approved only together with dexamethasone, a steroid[1].
Source: Thalomid prescribing information (FDA, September 2026)
▸What is the Thalidomide REMS program?
The Thalidomide REMS is the FDA-required restricted program that controls how thalidomide is prescribed and dispensed because of the risk of birth defects[1].
Who enrolls: Prescribers and pharmacies must be certified, and patients sign a Patient-Physician Agreement Form[1].
Pregnancy tests: People who can become pregnant need 2 negative tests before starting, then weekly tests in the first month and monthly after[1].
Men: Thalidomide is present in semen, so male patients must use a latex or synthetic condom with partners who could become pregnant, even after a vasectomy[1].
Name change: The FDA approved the change from Thalomid REMS to Thalidomide REMS on September 2, 2026[7].
Contact: The label lists www.thalidomideremsprogram.com and 1-888-423-5436[1].
Source: Thalomid prescribing information (FDA, September 2026); FDA approval letter, September 2026
▸Does thalidomide cause permanent nerve damage?
It can; the label says thalidomide is known to cause nerve damage that may be permanent[1].
Symptoms: Early signs include numbness, tingling or pain in the hands and feet[1].
Timing: It usually appears after months of use, but can appear sooner or after treatment stops[1].
Checks: The label calls for nerve checks monthly for the first 3 months and periodically after that[1].
Trial rate: Numbness or tingling (sensory neuropathy) affected 54% on Thalomid and dexamethasone against 28% on dexamethasone alone in Study 1[1].
Source: Thalomid prescribing information (FDA, September 2026)
▸Why is Thalomid taken at bedtime?
The label recommends taking Thalomid at bedtime, at least 1 hour after the evening meal[1].
Drowsiness: The label says Thalomid frequently causes drowsiness and can impair driving or other hazardous tasks[1].
Dizziness: It can also cause dizziness on standing, so the label advises sitting upright for a few minutes before getting up[1].
Other sedatives: The label advises avoiding other sedating medicines and alcohol without medical advice[1].
Source: Thalomid prescribing information (FDA, September 2026)
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. Food and Drug Administration (Celgene Corporation, a Bristol-Myers Squibb company) · 2026-09. THALOMID (thalidomide) capsules, full prescribing information, revised 9/2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020785s074lbl.pdf
- U.S. Food and Drug Administration · 2026-09-02. Drugs@FDA: THALOMID, NDA 020785 (original approval July 16, 1998; myeloma approval May 25, 2006). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020785
- ClinicalTrials.gov · 2026-11. A Multicenter, Randomized, Parallel-group, Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma. https://clinicaltrials.gov/study/NCT00057564
- U.S. National Library of Medicine, DailyMed (Celgene Corporation, a Bristol-Myers Squibb company) · 2023-03. REVLIMID (lenalidomide) capsules, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fa97bf5-28a2-48f1-8955-f56012d296be
- U.S. National Library of Medicine, DailyMed (Celgene Corporation, a Bristol-Myers Squibb company) · 2025-02. POMALYST (pomalidomide) capsules, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2b25ef01-5c9e-11e1-b86c-0800200c9a66
- U.S. Food and Drug Administration · 2012-02-03. NDA 020785/S-035/S-040/S-043 supplement approval: labeling updated with THAL-MM-003 results. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf
- U.S. Food and Drug Administration · 2026-09-02. NDA 020785/S-074 supplement approval: Thalomid REMS renamed Thalidomide REMS and converted to a shared system. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/020785Orig1s074ltr.pdf
- U.S. Food and Drug Administration · 2026-04-24. ANDA 213267 approval: Thalidomide Capsules USP, 50mg, 100mg, 150mg and 200mg (Natco Pharma Limited). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213267Orig1s000Panoramaltr.pdf