Thalomid Side Effects

Generic name: thalidomide

Note: This document contains side effect information about thalidomide. Some of the dosage forms listed on this page may not apply to the brand name Thalomid.

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

For the Consumer

Applies to thalidomide: oral capsule

Stop using this medicine and Get emergency medical help if you have any of these signs of an allergic reaction while taking thalidomide (the active ingredient contained in Thalomid) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• chest pain, sudden shortness of breath, coughing up blood;

• pain or swelling in your arm, thigh, or calf;

• fever, chills, body aches, flu symptoms, easy bruising or bleeding;

• slow heartbeats, shallow breathing, feeling like you might pass out;

• a red, blistering, peeling skin rash;

• a red, raised skin rash (especially if you also have fever, fast heart rate, and dizziness or fainting);

• numbness, burning, pain, or tingly feeling; or

• seizure (convulsions).

Less serious side effects of thalidomide may include:

• feeling drowsy or sleepy;

• anxiety, confusion, tremors or shaking;

• bone pain, muscle weakness;

• sleep problems (insomnia); or

• nausea, constipation, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

Hematologic

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.

Immunologic

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.

Dermatologic

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.

Gastrointestinal

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.

Genitourinary

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.

General

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.

Musculoskeletal

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.

Metabolic

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.

Cardiovascular

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

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.

Hepatic

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.

Respiratory

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.

Oncologic

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

Endocrine

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

Other

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

Ocular

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

Psychiatric

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

Renal

Renal side effects have included acute renal failure and oliguria.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction.

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