Thalidomide
Thalidomide is an oral prescription medicine used to treat newly diagnosed multiple myeloma (with dexamethasone) and the skin symptoms of erythema nodosum leprosum, and it carries serious warnings about birth defects and blood clots.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Thalidomide (Thalomid), on the U.S. market since about 1998, is a specialist drug that calms the immune system and slows new blood vessel growth. It is used for newly diagnosed multiple myeloma (a bone marrow cancer, alongside dexamethasone) and for erythema nodosum leprosum, a painful skin reaction linked to leprosy. Side effects are common, mainly drowsiness, tiredness and constipation, and numbness or tingling in the hands and feet deserves a prompt call because the nerve damage can be permanent. Its boxed warning covers severe birth defects, even from one capsule, and blood clots, so get care right away for shortness of breath, chest pain or a swollen arm or leg.
Clinical pearls
- It comes only through the THALOMID REMS safety program, with certified prescribers and pharmacies and a signed agreement from you.
- Take it at bedtime, an hour or more after dinner, and avoid alcohol and sleep aids, which deepen the drowsiness.
- Men need a latex or synthetic condom with any partner able to become pregnant, even after a vasectomy.
- If you get up at night, sit upright for a few minutes first, since it can cause dizziness on standing.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Thalidomide can cause severe birth defects or death of an unborn baby, even from a single capsule. It must never be used by anyone who is pregnant or could become pregnant while taking it. Pregnancy must be ruled out before starting, and two reliable forms of birth control are required afterward. Because of this, it is only available through the THALOMID REMS program.
It also raises the risk of dangerous blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) in people with multiple myeloma. The risk is much higher when it is taken with dexamethasone. In one trial, clots occurred in 22.5% of people taking both medicines versus 4.9% with dexamethasone alone. Seek medical care right away for shortness of breath, chest pain, or arm or leg swelling.
Patient information guide A plain-language walkthrough of Thalidomide, written from its FDA label.
What Thalidomide is used for
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Thalidomide is used for two conditions:
- Newly diagnosed multiple myeloma: Thalomid is used together with dexamethasone.
- Erythema nodosum leprosum (ENL): Thalomid is used for acute treatment of moderate to severe skin symptoms, and as maintenance therapy to prevent and suppress their return.
- Thalomid is not indicated as the only treatment for ENL when moderate to severe neuritis (nerve inflammation) is present.
How Thalidomide works
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The way thalidomide works is not fully understood. It attaches to a protein called cereblon, which is part of the cell's protein-recycling machinery. It has immune-modulating, anti-inflammatory, and anti-angiogenic effects, meaning it limits new blood vessel growth.
It may lower excess TNF-alpha, an inflammatory signal, and affect cells involved in immune movement. In myeloma, it was linked to more natural killer cells and higher levels of some immune-signaling proteins.
Thalidomide dosage
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Thalomid is a capsule taken by mouth once daily with water. It is usually taken at bedtime and at least 1 hour after the evening meal.
- Multiple myeloma: taken in 28-day cycles with dexamethasone.
- ENL: the dose depends on severity and body weight. It continues until active symptoms settle, then is slowly tapered. Some people need low-dose maintenance.
- Your prescriber may pause or lower the dose for constipation, drowsiness, or nerve symptoms.
Follow your prescriber and the label for your exact dose.
Dosing details from the FDA-approved label
From the Thalidomide prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Multiple myeloma (MM), in combination with dexamethasone
- THALOMID 200 mg once daily (in 28-day treatment cycles) orally with water, preferably at bedtime and at least 1 hour after the evening meal
- Dexamethasone 40 mg daily administered orally on days 1-4, 9-12, and 17-20 every 28 days
- Erythema nodosum leprosum (ENL): episode of cutaneous ENL
- 100 to 300 mg/day once daily orally with water, preferably at bedtime and at least 1 hour after the evening meal
- Initiate dosing for patients weighing less than 50 kilograms at the low end of the dose range.
- Erythema nodosum leprosum (ENL): severe cutaneous ENL reaction, or patients who previously required higher doses
- Consider the higher dosage range, once daily at bedtime or in divided doses with water, at least 1 hour after meals
- Maximum: possibly up to 400 mg/day
- Erythema nodosum leprosum (ENL): tapering after the reaction subsides
- Continue dosing until signs and symptoms of active reaction have subsided, usually at least 2 weeks
- Then taper off in 50 mg decrements every 2 to 4 weeks
- Erythema nodosum leprosum (ENL): history of prolonged maintenance treatment or flare during tapering
- Maintain on the minimum dose necessary to control the reaction
- Attempt tapering off every 3 to 6 months, in decrements of 50 mg every 2 to 4 weeks
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • MM: 200 mg orally once daily. The recommended dose of dexamethasone is 40 mg/day on days 1-4, 9-12, and 17-20 every 28 days. ( 2.2 ) • ENL: 100 to 300 mg/day for an episode of cutaneous ENL. Up to 400 mg/day for severe cutaneous ENL. ( 2.3 ) 2.1 Required Baseline Testing Drug prescribing to females of reproductive potential is contingent upon initial and continued negative results of pregnancy testing [see Warnings and Precautions (5.1 and 5.2) ] . THALOMID must only be administered in compliance with all of the terms outlined in the THALOMID REMS program. THALOMID may only be prescribed by prescribers certified with the THALOMID REMS program and may only be dispensed by pharmacists certified with the THALOMID REMS program. 2.2 Recommended Dosage for Multiple Myeloma The recommended dose of THALOMID in combination with dexamethasone is 200 mg once daily (in 28-day treatment cycles) orally with water, preferably at bedtime and at least 1 hour after the evening meal. The dose of dexamethasone is 40 mg daily administered orally on days 1-4, 9-12, and 17-20 every 28 days. 2.3 Recommended Dosage for Erythema Nodosum Leprosum The recommended dose of THALOMID for an episode of cutaneous ENL is 100 to 300 mg/day once daily orally with water, preferably at bedtime and at least 1 hour after the evening meal. Initiate dosing for patients weighing less than 50 kilograms at the low end of the dose range. Consider dosing in the higher dosage range for patients with a severe cutaneous ENL reaction, or in those who have previously required higher doses to control the reaction (possibly up to 400 mg/day) once daily at bedtime or in divided doses with water, at least 1 hour after meals. Consider concomitant use of corticosteroids in patients with moderate to severe neuritis associated with a severe ENL reaction. Steroid usage can be tapered and discontinued when the neuritis has ameliorated. Continue dosing with THALOMID until signs and symptoms of active reaction have subsided, usually a period of at least 2 weeks. Patients may then be tapered off medication in 50 mg decrements every 2 to 4 weeks. Patients who have a documented history of requiring prolonged maintenance treatment to prevent the recurrence of cutaneous ENL or who flare during tapering should be maintained on the minimum dose necessary to control the reaction.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Thalidomide side effects
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Most people taking thalidomide have some side effects. Common ones include:
Common side effects
- Fatigue
- Constipation
- Swelling (edema)
- Drowsiness
- Numbness or tingling in hands and feet
- Dizziness
- Tremor
- Rash
- Headache (in ENL)
- Low calcium, nausea, loss of appetite, and confusion (in myeloma studies)
When to get medical help
- Seek immediate care for shortness of breath, chest pain, or swelling in an arm or leg, which can signal a blood clot.
- Call your doctor right away if you think you may be pregnant, or if you miss a period or have unusual menstrual bleeding.
- Tell your doctor about numbness, tingling, or pain in your hands or feet. Nerve damage can be permanent.
- Stop the medicine and get help for swelling of the face or throat, trouble breathing, or a severe skin reaction with blistering or peeling.
- Report a very slow heartbeat or fainting.
- Report any seizure.
- Report new or worsening signs of infection, since white blood cell and platelet counts can drop.
Thalidomide warnings and precautions
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- Birth defects: thalidomide is a powerful teratogen (a drug that harms a developing baby). Even one dose can cause severe or deadly birth defects. Strict REMS rules apply.
- Blood clots, heart attack and stroke: risk is higher with dexamethasone in multiple myeloma.
- Nerve damage: it may be permanent and can appear after treatment stops. You will be checked regularly.
- Drowsiness and dizziness: avoid driving and dangerous tasks if affected. Stand up slowly.
- Low blood counts, slow heartbeat, seizures, severe skin reactions, serious allergy, and tumor lysis syndrome (rapid breakdown of cancer cells) can occur.
- HIV: viral load can increase, so it is measured during treatment.
Thalidomide interactions
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Several drug types can add to thalidomide's risks:
- Sedating drugs and alcohol (opioids, antihistamines, antipsychotics, anti-anxiety medicines): more drowsiness.
- Heart-slowing drugs (beta blockers, calcium channel blockers, digoxin, and others): more risk of slow heartbeat.
- Nerve-damaging drugs (such as bortezomib, cisplatin, vincristine, metronidazole): added nerve risk.
- Estrogen-containing therapies and erythropoietin-type drugs: possible higher clot risk.
- Drugs and St. John's Wort that weaken hormonal birth control: two other effective methods are needed.
- Pembrolizumab with a thalidomide-type drug and dexamethasone: higher risk of death in myeloma, so not recommended outside trials.
Interactions listed in the FDA-approved label
From the Thalidomide prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants (including alcohol): May cause an additive sedative effect with THALOMID. Should be avoided.
- Drugs which cause bradycardia (calcium channel blockers, beta blockers, alpha/beta-adrenergic blockers, digoxin, H2 blockers, lithium, tricyclic antidepressants, neuromuscular blockers such as succinylcholine): Drugs which slow cardiac conduction may cause an additive bradycardic effect with THALOMID. Use with caution.
- Digoxin: In 16 healthy men, the pharmacokinetic profile of a single 0.5 mg digoxin dose was similar with and without THALOMID 200 mg/day at steady state, and digoxin had no effect on THALOMID pharmacokinetics. The safety of long-term concomitant use has not been evaluated.
- Drugs which cause peripheral neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol): Can cause an additive effect with THALOMID. Use with caution.
- Hormonal contraceptives: Hormonal contraceptives increase the risk of thromboembolism; it is not known whether concomitant use further increases the risk with THALOMID. Pharmacokinetics of norethindrone and ethinyl estradiol were similar with and without THALOMID 200 mg/day.
- Warfarin: Pharmacokinetic profile and INR of a single 25 mg warfarin dose were similar with and without THALOMID 200 mg/day at steady state; warfarin had no effect on thalidomide pharmacokinetics.
- HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements such as St. John's Wort: With hormonal contraceptive agents, may reduce the effectiveness of the contraception up to one month after discontinuation of these therapies. Females requiring one or more of these drugs must use two OTHER effective or highly effective methods of contraception while taking THALOMID.
- Erythropoietic agents or other agents that may increase the risk of thromboembolism, such as estrogen containing therapies: May increase the risk of thromboembolism in multiple myeloma patients receiving THALOMID with dexamethasone. Should be used with caution.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Use caution if other drugs which have sedative and hypnotic properties, slow cardiac conduction and/or cause peripheral neuropathy must be used. ( 7.1 , 7.2 , 7.3 ) • It is not known whether concomitant use of hormonal contraceptives further increases the risk of thromboembolism with THALOMID. ( 5.15 , 7.4 ) • Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thromboembolism. ( 7.7 ) 7.1 Opioids, Antihistamines, Antipsychotics, Anti-anxiety Agents, or Other CNS Depressants (Including Alcohol) The use of opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants concomitantly with THALOMID may cause an additive sedative effect and should be avoided. 7.2 Drugs which Cause Bradycardia The use of drugs which slow cardiac conduction concomitantly with THALOMID may cause an additive bradycardic effect and should be used with caution. Cardiovascular medications which may cause bradycardia include calcium channel blockers, beta blockers, alpha/beta-adrenergic blockers, and digoxin. Non-cardiac drugs that may cause bradycardia include H2 blockers (e.g., famotidine, cimetidine), lithium, tricyclic antidepressants and neuromuscular blockers (succinylcholine). In 16 healthy men, the pharmacokinetic profile of a single 0.5 mg digoxin dose was similar with and without the coadministration of THALOMID 200 mg/day at steady state levels. The single dose of digoxin had no effect on the pharmacokinetic profile of THALOMID. The safety of long-term concomitant use of THALOMID and digoxin has not been evaluated. 7.3 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.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Thalidomide
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- Not for anyone who is pregnant, or allergic to thalidomide or its ingredients.
- Women who can become pregnant need two negative pregnancy tests, repeated testing, and two forms of birth control. Continue for 4 weeks after the last dose.
- Men need a latex or synthetic condom during treatment and for up to 4 weeks after, and must not donate sperm. Male fertility may be affected.
- No blood donation during treatment or for 4 weeks after.
- Do not breastfeed.
- Tell your doctor about seizures, HIV, slow heart rate, or past clots or heart disease.
- Safety in children under 12 has not been established.
- Older adults had higher rates of several side effects, including blood clots and atrial fibrillation.
Thalidomide overdose
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There is no specific antidote for a thalidomide overdose. Treatment is supportive, with monitoring of vital signs and care to maintain blood pressure and breathing. Get emergency help if you take too much.
What Thalidomide does in the body
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Thalidomide has immune-modulating, anti-inflammatory, and anti-angiogenic effects. In people with ENL it has been reported to lower TNF-alpha, while in HIV-positive patients it raised it. In myeloma patients, it was linked to more natural killer cells and higher interleukin-2 and interferon-gamma levels.
How your body processes Thalidomide
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Thalidomide is absorbed slowly after you swallow it. Blood levels peak about 2 to 5 hours later. In studies, more than 90% of a radiolabeled dose was recovered in urine, which suggests good absorption. Average half-life in single-dose studies was roughly 5.5 to 7.3 hours.
How to store Thalidomide
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This drug must not be repackaged. Store at 20°C- 25°C (68°F -77°F); excursions permitted to 15-30º C (59-86º F). Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Thalidomide
70 supplements and herbal products have documented interactions with Thalidomide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 59
- Minor · 10
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Thalidomide: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Thalidomide — the kind of thing our pharmacy team would talk through with you at the counter.
What is thalidomide for?
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How should I take my capsules?
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Why are there so many rules about pregnancy?
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What side effects are normal, and what should I call about?
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Can I drink alcohol or take sleep aids with it?
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Can I drive while taking it?
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Is Thalidomide available over the counter?
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When was Thalidomide first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Thalidomide on HelloPharmacist
Thalidomide forms and strengths (how it comes)
Thalidomide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Thalomid with dexamethasone is used for newly diagnosed multiple myeloma.
- Thalomid is used for acute treatment of moderate to severe skin symptoms of erythema nodosum leprosum, and to prevent their return.
- Thalomid is taken by mouth once daily with water, usually at bedtime and at least 1 hour after the evening meal.
- Thalomid capsules should stay in their blister packs until you take them.
- Women who could become pregnant should avoid contact with Thalomid capsules. If a capsule is broken or powder touches skin, wash the area with soap and water.
- Thalomid is only dispensed through the THALOMID REMS program.
Thalidomide on the U.S. market: products, makers and brands
How Thalidomide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 4 Thalidomide product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1998. Brand names on the directory include Thalomid; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Thalidomide products
A representative set of FDA-listed product records for Thalidomide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 50 mg | Oral | Celgene Corporation | NDA | View NDC → |
| 100 mg | Oral | Celgene Corporation | NDA | View NDC → |
| 150 mg | Oral | Celgene Corporation | NDA | View NDC → |
| 200 mg | Oral | Celgene Corporation | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Thalidomide NDCs →
Thalidomide side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Thalidomide — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Thalidomide in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Thalidomide FDA approval history
How Thalidomide went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Thalidomide recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Thalidomide recalls since July 2021.
✅No Thalidomide recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 10432 1 dose form · 4 strengths
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Dose form (SCDF) Oral Capsule RxCUI 374072In current FDA listings
Look up RxCUI 10432 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Thalidomide supply and shortage status
Whether Thalidomide is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Thalidomide brand names
Thalidomide is sold under one brand name in the FDA directory — Thalomid. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Thalidomide: manufacturers and labelers
One company lists Thalidomide products with the FDA. By number of product records, the largest are Celgene Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Thalidomide drug class (RxNorm)
Thalidomide belongs to the Other immunosuppressants class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Thalidomide page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Celgene Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →