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Thalidomide Side Effects

Medically reviewed by Last updated on Jan 24, 2024.

Applies to thalidomide: oral capsule.


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.

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


Incidence not known

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

Less common

For Healthcare Professionals

Applies to thalidomide: oral capsule.


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]


Very common (10% or more): Hypocalcemia (95%), anorexia (28%), weight loss (23%), weight gain (22%)

Common (1% to 10%): Hypokalemia, hyperlipidemia

Rare (less than 0.1%): Increased appetite

Frequency not reported: Increased appetite, electrolyte abnormalities, hyperkalemia, hypocalcemia, hypoproteinemia, increased lactate dehydrogenase (LDH), decreased phosphorus

Postmarketing reports: Tumor lysis syndrome, hypercalcemia, hyponatremia, hypomagnesemia[Ref]


Very common (10% or more): Fatigue (79%), edema (56%), peripheral edema (34%), asthenia (24%), pyrexia/fever (24%)

Common (1% to 10%): Accidental injury, chills, infection, pain, malaise, weakness, lethargy

Frequency not reported: Tinnitus, palpable spleen

Postmarketing reports: Sepsis, septic shock, hearing impairment/deafness, hangover effect[Ref]


Very common (10% or more): Constipation (55%), nausea (28%), diarrhea (18.7%), dry mouth (12%), oral moniliasis (11.1%), dyspepsia (11%)

Common (1% to 10%): Abdominal pain, vomiting, flatulence

Uncommon (0.1% to 1%): Diverticular perforation, peritonitis

Very rare (less than 0.01%): Intestinal obstruction

Frequency not reported: Enlarged abdomen, eructation

Postmarketing reports: Gastrointestinal (GI) perforation, GI hemorrhage, pancreatitis, bile duct obstruction, stomach ulcer, aphthous stomatitis[Ref]

Nervous system

Very common (10% or more): Sensory neuropathy (54%), drowsiness/somnolence/sedation (37.5%), tremor (26%), dizziness/lightheadedness (23%), motor neuropathy (22%), headache (18.7%), depressed level of consciousness (16%), paresthesia (15.6%), sensory peripheral neuropathy (10%)

Common (1% to 10%): Cerebrovascular accident/event, syncope, vertigo, abnormal coordination, transient ischemic event, ataxia, amnesia, causalgia, circumoral paresthesia, hyperesthesia, dysesthesia

Frequency not reported: Neuritis, peripheral neuritis, neuralgia, hypertonia

Postmarketing reports: Seizures, convulsions, Parkinson's disease/worsening of Parkinson's disease symptoms, posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS), stupor, stroke, carpal tunnel, Raynaud's syndrome, migraine, foot drop[Ref]


Very common (10% or more): Neutropenia (42.7%), decreased leukocytes (35%), decreased neutrophils (31%), leukopenia (25.8%), anemia (13.7%), lymphadenopathy (12.5%), lymphopenia (12.1%), thrombocytopenia (11.3%)

Very rare (less than 0.01%): Eosinophilia

Frequency not reported: Increased/decreased platelet count, decreased erythrocyte sedimentation rate (ESR), granulocytopenia, hypochromic anemia, leukocytosis, elevated mean corpuscular volume (MCV), abnormal red blood cell (RBC) count

Postmarketing reports: Febrile neutropenia, pancytopenia, decreased white blood cell (WBC) count, prothrombin time changes, lymphedema[Ref]


Very common (10% or more): Dyspnea (42%), pneumonia (15%)

Common (1% to 10%): Bronchopneumonia, pulmonary embolism, pharyngitis, sinusitis, interstitial lung disease

Uncommon (0.1% to 1%): Bronchitis

Very rare (less than 0.01%): Bronchospasm

Frequency not reported: Cough, emphysema, epistaxis, rales, upper respiratory infection, voice alteration[Ref]


Very common (10% or more): Muscle weakness (40%), myalgia (17%), arthralgia (13%)

Common (1% to 10%): Muscle cramps

Frequency not reported: Upper extremity pain, arthritis, bone tenderness, joint disorder, leg cramps, myasthenia, periosteal disorder[Ref]


Very common (10% or more): Rash/desquamation (30%), rash (25%), dry skin (21%), maculopapular rash (18.7%), sweating (12.5%), acne (11.1%)

Common (1% to 10%): Fungal dermatitis, nail disorder, pruritus, toxic skin eruption, urticaria

Very rare (less than 0.01%): Severe skin reactions (Stevens-Johnson Syndrome, toxic epidermal necrolysis), facial edema, photosensitivity, alopecia, eczematous rash, exfoliative dermatitis, ichthyosis, perifollicular thickening, skin necrosis, seborrhea, sweating, vesiculobullous rash

Postmarketing reports: Erythema multiforme, erythema nodosum, purpura, petechiae[Ref]


Very common (10% or more): Confusion (28%), anxiety/agitation (26%), depression (10%)

Common (1% to 10%): Insomnia, nervousness, abnormal thinking, euphoria, impotence, altered mood/mood changes/mental status changes

Very rare (less than 0.01%): Decreased libido

Frequency not reported: Psychosis

Postmarketing reports: Sexual dysfunction, suicide attempts[Ref]


Very common (10% or more): Thrombosis/embolism (22%), deep vein thrombosis (13%)

Common (1% to 10%): Atrial fibrillation, myocardial ischemia/infarction, bradycardia, cardiac failure, hypotension

Uncommon (0.1% to 1%): Orthostatic hypotension

Rare (less than 0.1%): Tachycardia, cardiac arrhythmia

Frequency not reported: Hypertension, peripheral vascular disorder, vasodilation, cyanosis

Postmarketing reports: Atrioventricular block, pulmonary hypertension, sick sinus syndrome, electrocardiogram (ECG) abnormalities[Ref]


Very common (10% or more): Hyperglycemia (15%)

Very rare (less than 0.01%): Hypothyroidism, menstruation abnormalities, amenorrhea

Frequency not reported: Diabetes, inappropriate antidiuretic hormone (ADH)

Postmarketing reports: Myxedema, galactorrhea, gynecomastia[Ref]


Very common (10% or more): Abnormal bilirubin level (14%), increased SGOT (12.5%)

Common (1% to 10%): Abnormal liver function tests

Frequency not reported: Enlarged liver, bilirubinemia, increased SGPT

Postmarketing reports: Increased alkaline phosphatase[Ref]


Very common (10% or more): Hematuria (11.1%)

Common (1% to 10%): Albuminuria

Frequency not reported: Hyperuricemia, proteinuria, pyuria, urinary frequency, orchitis

Postmarketing reports: Oliguria, enuresis, metrorrhagia[Ref]


Common (1% to 10%): Blurred vision

Frequency not reported: Amblyopia, dry eye, eye pain

Postmarketing reports: Diplopia, nystagmus[Ref]


Frequency not reported: Hypersensitivity/allergic reactions, angioedema[Ref]


Frequency not reported: Viral reactivation (herpes zoster, hepatitis B, cytomegalovirus), increased HIV viral load/RNA levels, amyloidosis

Postmarketing reports: Viral infections[Ref]


Frequency not reported: Acute myeloid leukemia, myelodysplastic syndromes

Postmarketing reports: Chronic myelogenous leukemia, nodular sclerosing Hodgkin's disease, erythroleukemia[Ref]


Frequency not reported: Increased BUN, increased creatinine

Postmarketing reports: Renal failure, acute renal failure[Ref]


1. Product Information. Thalomid (thalidomide). Celgene Corporation. 2001;PROD.

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

3. Fox MR, Harris A. Intractable insomnia after cessation of treatment with thalidomide. Gastroenterology. 2001;120:1567-8.

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

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

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

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

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

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

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

11. Duyvendak M, Naunton M, Kingma BJ, Brouwers JR. Thalidomide-associated thrombocytopenia. Ann Pharmacother. 2005;39:1936-9.

12. Gordinier ME, Dizon DS. Dyspnea during thalidomide treatment for advanced ovarian cancer. Ann Pharmacother. 2005;39:962-5.

13. Horowitz SB, Stirling AL. Thalidomide-induced toxic epidermal necrolysis. Pharmacotherapy. 1999;19:1177-80.

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

15. Hamnvik OP, Larsen PR, Marqusee E. Thyroid dysfunction from antineoplastic agents. J Natl Cancer Inst. 2011;103:1572-87.

16. Hanje AJ, Shamp JL, Thomas FB, Meis GM. Thalidomide-induced severe hepatotoxicity. Pharmacotherapy. 2006;26:1018-22.

17. Hamadani M, Benson DM Jr, Copelan EA. Thalidomide-induced fulminant hepatic failure. Mayo Clin Proc. 2007;82:638.

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

19. Feaver AA, McCune DE, Mysliwiec AG, Mysliwiec V. Thalidomide-induced organizing pneumonia. South Med J. 2006;99:1292-4.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.