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Thalidomide Side Effects

For the Consumer

Applies to thalidomide: oral capsule

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
  • Anxiety
  • chest pain
  • cough
  • dizziness or lightheadedness
  • fainting
  • fast heartbeat
  • muscle weakness
  • pain, redness, or swelling in the arm or leg
  • sudden shortness of breath or troubled breathing
  • tingling, burning, numbness, or pain in the hands, arms, feet, or legs
Rare
  • Blood in the urine
  • decreased urination
  • fever, alone or with chills and sore throat
  • irregular heartbeat
  • low blood pressure
  • skin rash
Incidence not known
  • Black, tarry stools
  • bleeding gums
  • blistering of the skin
  • blood in the stools
  • confusion
  • convulsions
  • difficulty with speaking
  • double vision
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • itching skin
  • muscle jerking of the arms and legs
  • peeling and loosening of the skin
  • pinpoint red spots on the skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • slow speech
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden loss of consciousness
  • unusual bleeding or bruising

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
  • Constipation
  • diarrhea
  • drowsiness
  • nausea
  • stomach pain
Less common
  • Dry skin
  • dryness of the mouth
  • headache
  • increased appetite
  • mood changes

For Healthcare Professionals

Applies to thalidomide: oral capsule

General

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

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]

Other

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]

Gastrointestinal

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]

Hematologic

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]

Respiratory

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]

Musculoskeletal

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]

Dermatologic

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]

Psychiatric

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]

Cardiovascular

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]

Endocrine

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]

Hepatic

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]

Genitourinary

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]

Ocular

Common (1% to 10%): Blurred vision
Frequency not reported: Amblyopia, dry eye, eye pain
Postmarketing reports: Diplopia, nystagmus[Ref]

Hypersensitivity

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

Immunologic

Frequency not reported: Viral reactivation (herpes zoster, hepatitis B, cytomegalovirus), increased HIV viral load/RNA levels, amyloidosis
Postmarketing reports: Viral infections[Ref]

Oncologic

Frequency not reported: Acute myeloid leukemia, myelodysplastic syndromes
Postmarketing reports: Chronic myelogenous leukemia, nodular sclerosing Hodgkin's disease, erythroleukemia[Ref]

Renal

Frequency not reported: Increased BUN, increased creatinine
Postmarketing reports: Renal failure, acute renal failure[Ref]

References

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

2. "Product Information. Thalomid (thalidomide)." Celgene Corporation, Warren, NJ.

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

4. 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 341 (1999): 1565-71

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

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

7. 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 117 (1999): 1278-87

8. 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 24 (2006): 4942-4

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

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

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

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

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

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

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

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

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

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

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

Some side effects of thalidomide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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