Last reviewed 2026-04-20 · How we verify

Thalomid (THALIDOMIDE)

Thalomid works by inhibiting the production of tumor necrosis factor, a protein that promotes inflammation and tumor growth.

At a glance

Mechanism of action

The mechanism of action of THALOMID is not fully understood. Cellular activities of thalidomide are mediated through its target cereblon, component of cullin ring E3 ubiquitin ligase enzyme complex. THALOMID possesses immunomodulatory, anti-inflammatory and antiangiogenic properties. Available data from in vitro studies and clinical trials suggest that the immunologic effects of this compound can vary substantially under different conditions, but may be related to suppression of excessive tumor necrosis factor-alpha (TNF-) production and down-modulation of selected cell surface adhesion molecules involved in leukocyte migration. For example, administration of thalidomide has been reported to decrease circulating levels of TNF- in patients with erythema nodosum leprosum (ENL); however, it has also been shown to increase plasma TNF- levels in HIV-seropositive patients. Other anti-inflammatory and immunomodulatory properties of thalidomide may include suppression

Approved indications

• Newly Diagnosed Multiple Myeloma
• Acute Treatment of Moderate to Severe ENL
• Maintenance Therapy for ENL Recurrence

Boxed warnings

• WARNING: 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. Because of this toxicity and in an effort to make the chance of embryo-fetal exposure to THALOMID as negligible as possible, THALOMID is approved for marketing only through a special restricted distribution program: THALOMID REMS program, approved by the Food and Drug Administration. Information about THALOMID and the THALOMID REMS program is available at www.thalomidrems.com or by calling the REMS Call Center at 1-888-423-5436. VENOUS THROMBOEMBOLISM The use of THALOMID in multiple myeloma results in an increased risk of venous thromboembolism, such as deep venous thrombosis and pulmonary embolism. This risk increases significantly when THALOMID is used in combination with standard chemotherapeutic agents including dexamethasone. In one controlled trial, the rate of venous thromboembolism was 22.5% in patients receiving THALOMID in combination with dexamethasone compared to 4.9% in patients receiving dexamethasone alone (p = 0.002). Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. Instruct patients to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Consider thromboprophylaxis based on an assessment of individual patients' underlying risk factors.

Common side effects

• Fatigue
• Hypocalcemia
• Edema
• Constipation
• Neuropathy-sensory
• Dyspnea
• Muscle weakness
• Leukopenia
• Neutropenia
• Rash/desquamation
• Confusion
• Anorexia

Drug interactions

• Opioids, Antihistamines, Antipsychotics, Anti-anxiety Agents, or Other CNS Depressants (Including Alcohol)
• Drugs which Cause Bradycardia (Calcium channel blockers, Beta blockers, Alpha/beta-adrenergic blockers, Digoxin, H2 blockers, Lithium, Tricyclic antidepressants, Neuromuscular blockers)
• Drugs which Cause Peripheral Neuropathy (Bortezomib, Amiodarone, Cisplatin, Docetaxel, Paclitaxel, Vincristine, Disulfiram, Phenytoin, Metronidazole, Alcohol)
• Hormonal Contraceptives
• Erythropoietin Stimulating Agents or Estrogen Containing Therapies

Key clinical trials

• Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury. (PHASE2)
• Efficacy and Safety of Thalidomide for Pediatric PFAPA Syndrome (NA)
• Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis (PHASE3)
• A Clinical Study to Test the Effects of Ruxolitinib And Thalidomide Combination for Patients With Myelofibrosis (PHASE2)
• Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma (PHASE3)
• Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors (PHASE2)
• EDOCH Alternating With DHAP for New Diagnosed Younger MCL (PHASE4)
• The Efficacy of TCD Following by TP Maintenance Therapy in Newly Diagnosed WM (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Thalomid CI brief — competitive landscape report
• Thalomid updates RSS · CI watch RSS
• Bristol-Myers Squibb portfolio CI