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Thalidomide Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 11, 2025.

Applies to thalidomide: oral capsule.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Thalidomide can cause severe birth defects or embryofetal death, even with 1 dose, if taken during pregnancy.

Thalidomide distribution is restricted through the THALOMID REMS(TM) program (formerly known as the S.T.E.P.S.® program).

The use of thalidomide in multiple myeloma patients results in an increased risk of VTE , such as DVT and pulmonary embolism.

Coadministration of dexamethasone increases this risk.

Monitor for thromboembolism and consider thromboprophylaxis for individualized cases.

Precautions

It is very important that your doctor check your progress closely at regular visits to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for unwanted effects.

Women should take the necessary precautions to avoid pregnancy while taking thalidomide. Begin 2 forms of effective birth control together 4 weeks before starting treatment, during treatment, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Talk to your doctor about the most effective forms of birth control for you and your partner. Call your doctor right away if you think you are pregnant.

Women who can get pregnant must have a negative pregnancy test before starting treatment with this medicine. Pregnancy tests may be done weekly for the first month during treatment, and then every 2 to 4 weeks.

Men who are sexually active must protect their female partner from getting pregnant. Thalidomide will appear in the semen of male patients. If you are sexually active, you must use a latex or synthetic condom every time you have sex with a woman who could get pregnant. If you have had a vasectomy, you still have to use a latex condom during sex. You must use a condom during treatment, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Call your doctor right away if you think your sexual partner may be pregnant.

Do not donate blood or sperm while you are taking this medicine and for at least 4 weeks after your last dose.

You must not share this medicine with anyone, even someone who has similar symptoms.

This medicine may increase your risk of having blood clots, a heart attack, or stroke. Check with your doctor right away if you have shortness of breath, chest pain, or leg pain or swelling. These could be symptoms of blood clots. Symptoms of stroke include confusion, difficulty with speaking, double vision, inability to move the arms, legs, or facial muscles, or slow speech.

Do not receive pembrolizumab together with thalidomide and dexamethasone if you have multiple myeloma.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you feel lightheaded, getting up slowing after sitting or lying down may help.

Thalidomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

This medicine may cause nerve damage. Check with your doctor right away if you have tingling, burning, numbness, or pain in your hands or feet. These could be symptoms of a nerve condition called peripheral neuropathy.

Check with your doctor right away if you have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Thalidomide may cause a serious type of reaction called tumor lysis syndrome in patients with multiple myeloma. Call your doctor right away if you have less urine than normal, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using thalidomide.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of thalidomide

Along with its needed effects, thalidomide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking thalidomide:

More common side effects

  • anxiety
  • black, tarry stools
  • chest pain
  • chills
  • confusion
  • cough
  • dizziness or lightheadedness
  • dry mouth
  • fainting
  • fast heartbeat
  • fever
  • irregular heartbeat
  • irritability
  • loss of taste
  • lower back or side pain
  • mood or mental changes
  • muscle cramps in the hands, arms, feet, legs, or face
  • muscle weakness
  • nervousness
  • numbness and tingling around the mouth, fingertips, or feet
  • pain in the chest, groin, or legs, especially the calves
  • pain, redness, or swelling in the arm or leg
  • painful or difficult urination
  • pale skin
  • peeling and loosening of the skin
  • restlessness
  • seizures
  • severe, sudden headache
  • skin rash
  • shakiness in the legs, arms, hands, or feet
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach cramps
  • sudden, unexplained shortness of breath
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • swollen glands
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • tingling, burning, numbness, or pain in the hands, arms, feet, or legs
  • trembling or shaking of hands or feet
  • trouble sleeping
  • troubled breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vision changes

Rare side effects

  • blood in the urine
  • decreased urination

Incidence not known

  • bleeding gums
  • blistering of the skin
  • blood in the stools
  • difficulty with speaking
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • itching skin
  • muscle jerking of the arms and legs
  • pinpoint red spots on the skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • slow speech
  • sudden loss of consciousness

Other side effects of thalidomide

Some side effects of thalidomide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • constipation
  • dry skin
  • diarrhea
  • dizziness
  • drowsiness
  • loss of appetite
  • nausea
  • stomach pain
  • weight changes

Less common side effects

  • headache
  • increased appetite

For healthcare professionals

Applies to thalidomide: oral capsule.

General adverse events

In uncontrolled studies with HIV-seropositive patients, there were reports of adverse events (e.g., increased HIV viral load, decreased CD4 count, AIDS) that were not reported in other patient populations; consult the manufacturer product information.[Ref]

Metabolic

Other

Gastrointestinal

Nervous system

Hematologic

Respiratory

Musculoskeletal

Dermatologic

Psychiatric

Cardiovascular

Endocrine

Hepatic

Genitourinary

Ocular

Hypersensitivity

Immunologic

Oncologic

Renal

See also:

References

1. (2001) "Product Information. Thalomid (thalidomide)." Celgene Corporation

2. Duong DJ, Spigel GT, Moxley RT, Gaspari AA (1999) "American experience with low-dose thalidomide therapy for severe cutaneous lupus erythematosus." Arch Dermatol, 135, p. 1079-87

3. Fox MR, Harris A (2001) "Intractable insomnia after cessation of treatment with thalidomide." Gastroenterology, 120, p. 1567-8

4. Atra E, Sato EI (1993) "Treatment of the cutaneous lesions of systemic lupus erythematosus with thalidomide." Clin Exp Rheumatol, 11, p. 487-93

5. Singhal S, Mehta J, Desikan R, Ayers D, Roberson P, Eddlemon P, Munshi N, Anaissie E, Wilson C, Dhodapkar M, Zeldis J, Barlogie (1999) "Antitumor activity of thalidomide in refractory multiple myeloma." N Engl J Med, 341, p. 1565-71

6. Peuckmann V, Fisch M, Bruera E (2000) "Potential novel uses of thalidomide - Focus on palliative care." Drugs, 60, p. 273-92

7. Aronson IK, Yu R, West DP, Van Den Brock H, Antel J (1984) "Thalidomide-induced peripheral neuropathy." Arch Dermatol, 120, p. 1466-70

8. Keesal N, Wasserman MJ, Bookman A, Lapp V, Weber DA, Keystone EC (1999) "Thalidomide in the treatment of refractory rheumatoid arthritis." J Rheumatol, 26, p. 2344-7

9. Vasiliauskas EA, Kam LY, AbreuMartin MT, Hassard PV, Papadakis KA, Yang HY, Zeldis JB, Targan SR (1999) "An open-label pilot study of low-dose thalidomide in chronically active, steroid-dependent Crohn's disease." Gastroenterology, 117, p. 1278-87

10. Sohlbach K, Heinze S, Shiratori K, Sure U, Pagenstecher A, Neubauer A (2006) "Encephalopathy in a patient after long-term treatment with thalidomide." J Clin Oncol, 24, p. 4942-4

11. Duyvendak M, Naunton M, Kingma BJ, Brouwers JR (2005) "Thalidomide-associated thrombocytopenia." Ann Pharmacother, 39, p. 1936-9

12. Gordinier ME, Dizon DS (2005) "Dyspnea during thalidomide treatment for advanced ovarian cancer." Ann Pharmacother, 39, p. 962-5

13. Horowitz SB, Stirling AL (1999) "Thalidomide-induced toxic epidermal necrolysis." Pharmacotherapy, 19, p. 1177-80

14. Bennett CL, Angelotta C, Yarnold PR, et al. (2006) "Thalidomide- and lenalidomide-associated thromboembolism among patients with cancer." JAMA, 296, p. 2558-60

15. Hamnvik OP, Larsen PR, Marqusee E (2011) "Thyroid dysfunction from antineoplastic agents." J Natl Cancer Inst, 103, p. 1572-87

16. Hanje AJ, Shamp JL, Thomas FB, Meis GM (2006) "Thalidomide-induced severe hepatotoxicity." Pharmacotherapy, 26, p. 1018-22

17. Hamadani M, Benson DM Jr, Copelan EA (2007) "Thalidomide-induced fulminant hepatic failure." Mayo Clin Proc, 82, p. 638

18. Passeron T, Lacour JP, Murr D, Ortonne JP (2001) "Thalidomide-induced amenorrhoea: two cases." Br J Dermatol, 144, p. 1292-3

19. Feaver AA, McCune DE, Mysliwiec AG, Mysliwiec V (2006) "Thalidomide-induced organizing pneumonia." South Med J, 99, p. 1292-4

Further information

Thalidomide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.