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Thalidomide Side Effects

In Summary

Commonly reported side effects of thalidomide include: asthenia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to thalidomide: oral capsule

As well as its needed effects, thalidomide may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking thalidomide, check with your doctor immediately:

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
  • 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

Minor Side Effects

Some thalidomide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

Nervous system

Nervous system side effects have included somnolence (36.1% to 37.5%), dizziness (4.2% to 19.4%), paresthesia (5.6% to 15.6%), nervousness (2.8% to 9.4%), insomnia (9.4%), agitation (9.4%), peripheral neuropathy (8.3%), vertigo (8.3%), and tremor (4.2%). Other nervous system side effect have included abnormal thinking, amnesia, causalgia, circumoral paresthesia, confusion, hyperesthesia, neuralgia, migraine, abnormal gait, ataxia, decreased libido, decreased reflexes, dementia, dyskinesia, hypalgesia, hyperkinesia, incoordination, meningitis, neurologic disorder, dysesthesia, syncope, loss of consciousness, stupor, seizures, and neuritis. A case of encephalopathy has also been reported.[Ref]


Hematologic side effects have included leukopenia (16.7% to 25%), anemia (5.6% to 12.5%), and lymphadenopathy (5.6% to 12.5%). Other hematologic side effects have included decreased ESR, eosinophilia, granulocytopenia, leukemia, elevated MCV, pancytopenia, petechiae, purpura, erythroleukemia, lymphopenia, abnormal RBC, thrombocytopenia, neutropenia, febrile neutropenia, changes in prothrombin time, and enlarged spleen.[Ref]


Immunologic side effects have included fever (19.4% to 21.9%), and infection (6.3% to 8.3%). Other immunologic side effects have included amyloidosis, AIDS, viral infection, flu syndrome, decreased CD4 count, sepsis, organizing pneumonia, and moniliasis.[Ref]


Dermatologic side effects have included rash (20.8% to 25.0%), maculopapular rash (4.2% to 18.7%), sweating (12.5%), acne (3.1% to 11.1%), fungal dermatitis (4.2% to 9.4%), pruritus (2.8% to 6.3%), and nail disorder (3.1% to 4.2%). Other dermatologic side effects have included alopecia, dry skin, eczematous rash, exfoliative dermatitis, ichthyosis, perifollicular thickening, erythema nodosum, skin necrosis, angioedema, benign skin neoplasm, herpes simplex, incomplete Stevens-Johnson syndrome, psoriasis, aphthous stomatitis, skin discoloration, skin disorder, seborrhea, facial edema, cellulitis, erythema multiforme, and urticaria.[Ref]


Gastrointestinal side effects have included nausea (4.2% to 12.5%), diarrhea (4.2% to 11.1%), oral moniliasis (4.2% to 11.1%), dry mouth (8.3%), flatulence (8.3%), constipation (2.8% to 4.8%), abdominal pain (2.8% to 4.2%), and anorexia (2.8%). Other abdominal side effects have included colitis, dysphagia, esophagitis, gastroenteritis, gastrointestinal disorder, gastrointestinal hemorrhage, gum disorder, parotid gland enlargement, periodontitis, stomatitis, tongue discoloration, appetite increase, taste disturbance, intestinal obstruction, vomiting, abdominal distension, eructation, intestinal perforation, and dyspepsia.[Ref]


Genitourinary side effects have included hematuria (11.1%), albuminuria (3.1% to 8.3%), and impotence (2.8% to 8.3%). Other genitourinary side effects have included urinary incontinence, enuresis, orchitis, pyuria, amenorrhea, and urinary frequency.[Ref]


General side effects have included pain (8.3%), malaise (8.3%), tooth pain (4.25%), and accidental injury (4.2% to 5.6%). Other general side effects have included weight gain, hernia, chills and fever, and photosensitivity.[Ref]


Musculoskeletal side effects have included back pain (4.2% to 5.6%), neck pain (4.2%), and neck rigidity (4.2%). Other musculoskeletal side effects have included arthritis, bone tenderness, hypertonia, joint disorders, myalgia, myasthenia, periosteal disorder, twitching of the limbs, foot drop, upper extremity pain, carpal tunnel syndrome, intermittent shaking, and muscle cramps.[Ref]


Metabolic side effects have included increased SGOT (2.8% to 12.5%), hyperlipemia (2.% to 9.4%), and peripheral edema (3.1% to 8.3%). Other metabolic side effects have included bilirubinemia, increased BUN, increased creatinine, hyperkalemia, hypokalemia, hyperuricemia, hypomagnesemia, hypercalcemia, hypocalcemia, avitaminosis, increased lipase, increased alkaline phosphatase, hypercholesterolemia, hypoglycemia, dehydration, hypoproteinemia, electrolyte abnormalities, increased LDH, decreased phosphorus, hyponatremia, tumor lysis syndrome, and increased SGPT. A case of thalidomide-associated hyperglycemia and diabetes has also been reported.[Ref]


Cardiovascular side effects have included vasodilation, hypotension, bradycardia, thromboembolism, orthostatic hypotension, hypertension, angina pectoris, congestive heart failure, atrial fibrillation, cerebral ischemia, cerebrovascular accident, heart arrest, Raynaud's syndrome, murmur, myocardial infarct, palpitation, pericarditis, postural hypotension, syncope, tachycardia, thrombosis, sick sinus syndrome, EKG abnormalities, and peripheral vascular disorder.[Ref]

Some of the cases of bradycardia have required medical intervention. The clinical significance and underlying etiology of the bradycardia is unknown.[Ref]


Hepatic side effects have included multiple liver function test abnormalities (9.4%) in patients. Other hepatic side effects have included enlarged liver, cholangitis, cholestatic jaundice, bile duct obstruction and ascites. A case of severe hepatotoxicity and a case of fulminant hepatic failure have also been reported.[Ref]


Respiratory side effects have included pharyngitis (4.2% to 8.3%), sinusitis (3.1% to 8.3%), and rhinitis (4.2%). Other respiratory side effects have included cough, emphysema, epistaxis, pulmonary embolus, rales, voice alteration, apnea, bronchitis, lung disorder, lung edema, dyspnea, pneumonia, pleural effusion, and upper respiratory tract infection.[Ref]


Oncologic side effects have included myelogenous leukemia, nodular sclerosing Hodgkin's disease and sarcoma.[Ref]


Endocrine side effects have included inappropriate ADH, altered hormone levels, hypothyroidism, myxedema, gynecomastia, and diabetes.[Ref]


Otic side effects have included deafness and tinnitus. A case of intractable insomnia has also been reported.[Ref]


Ocular side effects have included dry eyes, diplopia, eye pain, conjunctivitis, eye disorder, lacrimation disorder, retinitis, and amblyopia.[Ref]


Psychiatric side effects have included mood changes, depression, euphoria, psychosis, and suicide attempts.[Ref]


Renal side effects have included acute renal failure and oliguria.[Ref]


Hypersensitivity side effects have included allergic reaction.[Ref]


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It is possible that some side effects of thalidomide may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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