Prescription medicine
Thalidomide First approved as Thalomid
Thalidomide (Thalomid) is a prescription medicine with an FDA approval on record since 1998. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the thalidomide FDA label on DailyMed (effective March 24, 2023, Celgene Corporation); the NDA 20785 record on Drugs@FDA; every thalidomide label on DailyMed.
Highlights of the record
FDA label of March 24, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM WARNING: EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM.
See full prescribing information for complete boxed warning. EMBRYO -FETAL TOXICITY
If THALOMID is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. THALOMID should never be used by females who are pregnant or who could be pregnant while taking the drug. Even a single dose [1 capsule (regardless of strength)] taken by a pregnant woman during her pregnancy can cause severe birth defects.
Pregnancy must be excluded before start of treatment. Prevent pregnancy thereafter by the use of two reliable methods of contraception. ( 5.1 , 8.3 ) THALOMID is only available through a restricted distribution program, the THALOMID REMS ® program ( 5.2 ). VENOUS THROMBOEMBOLISM
Significant increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma receiving THALOMID with dexamethasone ( 5.3 ). EMBRYO-FETAL TOXICITY If THALOMID is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. THALOMID should never be used by females who are pregnant or who could become pregnant while taking the drug. Even a single dose [1 capsule (regardless of strength)] taken by a pregnant woman during her pregnancy can cause severe birth defects. […]
Used for
From the label: indications and usageTHALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM).
Forms and strengths
- 50 mg
- 100 mg
- 150 mg
- 200 mg
Capsule.
On the market
- Earliest approval on file
- July 16, 1998 Thalomid, Bristol-Myers; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first April 27, 2023; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 36,498 through July 30, 2026
What is thalidomide used for?
From the label: indications and usageTHALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). ( 1.1 )
THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. […]
Conditions named in the indications of thalidomide's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Thalomid), NDA020785 (Bristol-Myers), as published by Celgene Corporation, effective March 24, 2023 (SPL set 2eda833b-1357-4ed4-a093-194524fcb061), via openFDA; the full label on DailyMed
What does the patient leaflet for thalidomide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about THALOMID?Before you begin taking THALOMID, you must read and agree to all of the instructions in the THALOMID REMS® program. For more information, call 1-888-423-5436 or go to www.thalomidrems.com. Before prescribing THALOMID, your healthcare provider will explain the THALOMID REMS program to you and have you sign the Patient-Physician Agreement Form. THALOMID can cause serious side effects including: • Severe and life-threatening human birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take THALOMID. • Females must not get pregnant: o For at least 4 weeks before starting THALOMID o While taking THALOMID o During any breaks (interruptions) in your treatment with THALOMID o For at least 4 weeks after stopping THALOMID • Females who can become pregnant: o Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. o If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling. o Must agree to use two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping THALOMID. o Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with THALOMID. o Stop taking THALOMID and call your healthcare provider right away if you have unprotected sex or if you think your birth control has failed. • If you become pregnant while taking THALOMID, stop taking it right away and call your healthcare provider. […]
From the patient leaflet: What should I avoid while taking THALOMID?See "What is the most important information I should know about THALOMID?" • Females: Do not get pregnant and do not breastfeed while taking THALOMID. • Males: Do not donate sperm. • Do not share THALOMID with other people. It may cause birth defects and other serious problems. • Do not donate blood while you take THALOMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping THALOMID. If someone who is pregnant gets your donated blood, her baby may be exposed to THALOMID and may be born with birth defects. • THALOMID can cause drowsiness and sleepiness. Avoid drinking alcohol, operating machinery, and driving a car when taking THALOMID. Avoid taking other medicines that may cause drowsiness without talking to your healthcare provider first.
From the patient leaflet: How should I store THALOMID?Store THALOMID at room temperature between 68°F to 77°F (20°C to 25°C). • Protect from light. • Return any unused THALOMID to THALOMID REMS by calling 1-888-423-5346 or your healthcare provider. Keep THALOMID and all medicines out of the reach of children.
Source: FDA drug label (Thalomid), NDA020785 (Bristol-Myers), as published by Celgene Corporation, effective March 24, 2023 (SPL set 2eda833b-1357-4ed4-a093-194524fcb061), via openFDA; the full label on DailyMed
Is there a generic for thalidomide (Thalomid)?
The FDA approved the first generic thalidomide on April 27, 2023. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
- 1998 earliest approval on file
- 2023 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the thalidomide label say about other medicines?
The thalidomide label names 23 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name thalidomide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Drugs which Cause Peripheral Neuropathy The use of drugs which cause peripheral neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol) can cause an additive effect and should be used with caution. |
| Bortezomib | drug interactions | Drugs which Cause Peripheral Neuropathy The use of drugs which cause peripheral neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol) can cause an additive effect and should be used with caution. |
| Carbamazepine | drug interactions | Drugs that Interfere with Hormonal Contraceptives Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements such as St. … |
| Cimetidine | drug interactions | Non-cardiac drugs that may cause bradycardia include H2 blockers (e.g., famotidine, cimetidine), lithium, tricyclic antidepressants and neuromuscular blockers (succinylcholine). |
| Cisplatin | drug interactions | Drugs which Cause Peripheral Neuropathy The use of drugs which cause peripheral neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol) can cause an additive effect and should be used with caution. |
| Dexamethasone | boxed warning | Significant increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma receiving THALOMID with dexamethasone ( 5.3 ). |
| Digoxin | drug interactions | Cardiovascular medications which may cause bradycardia include calcium channel blockers, beta blockers, alpha/beta-adrenergic blockers, and digoxin. |
| Disulfiram | drug interactions | Drugs which Cause Peripheral Neuropathy The use of drugs which cause peripheral neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol) can cause an additive effect and should be used with caution. |
| Docetaxel | drug interactions | Drugs which Cause Peripheral Neuropathy The use of drugs which cause peripheral neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol) can cause an additive effect and should be used with caution. |
| Famotidine | drug interactions | Non-cardiac drugs that may cause bradycardia include H2 blockers (e.g., famotidine, cimetidine), lithium, tricyclic antidepressants and neuromuscular blockers (succinylcholine). |
| Griseofulvin | drug interactions | Drugs that Interfere with Hormonal Contraceptives Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements such as St. … |
| Lithium | drug interactions | Non-cardiac drugs that may cause bradycardia include H2 blockers (e.g., famotidine, cimetidine), lithium, tricyclic antidepressants and neuromuscular blockers (succinylcholine). |
| Metronidazole | drug interactions | Drugs which Cause Peripheral Neuropathy The use of drugs which cause peripheral neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol) can cause an additive effect and should be used with caution. |
| Modafinil | drug interactions | Drugs that Interfere with Hormonal Contraceptives Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements such as St. … |
Every other medicine the thalidomide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Norethindrone | drug interactions | In 10 healthy women, the pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of a single dose containing 1.0 mg of norethindrone acetate and 75 mcg of ethinyl … |
| Paclitaxel | drug interactions | Drugs which Cause Peripheral Neuropathy The use of drugs which cause peripheral neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin … |
| Pembrolizumab | warnings and precautions | Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue. |
| Phenytoin | drug interactions | … amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol) can cause an additive effect and should be used with caution. |
| Rifabutin | drug interactions | Drugs that Interfere with Hormonal Contraceptives Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal … |
| Rifampin | drug interactions | Drugs that Interfere with Hormonal Contraceptives Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal … |
| Succinylcholine | drug interactions | Non-cardiac drugs that may cause bradycardia include H2 blockers (e.g., famotidine, cimetidine), lithium, tricyclic antidepressants and neuromuscular blockers (succinylcholine). |
| Vincristine | drug interactions | … neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol) can cause an additive effect and should be used with caution. |
| Warfarin | drug interactions | Warfarin In 13 healthy men, the pharmacokinetic profile and international normalized ratio (INR) of prothrombin time for warfarin, following a single oral dose of 25 mg, were similar with and without … |
Other labels that name thalidomide
Source: FDA drug label (Thalomid), NDA020785 (Bristol-Myers), as published by Celgene Corporation, effective March 24, 2023 (SPL set 2eda833b-1357-4ed4-a093-194524fcb061), via openFDA; the full label on DailyMed
What do FAERS reports show for thalidomide?
The FDA Adverse Event Reporting System holds 36,498 reports that list thalidomide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12,161 are coded as a death and 10,617 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as thalidomide?
37 other medicines are given the same way (oral) and in the same FDA class as thalidomide or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Thalidomide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other