Thalidomide Side Effects

Brand Names: Thalomid

Please note - some side effects for Thalidomide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Thalidomide - for the consumer

Thalidomide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Thalidomide:

Constipation; diarrhea; dizziness; drowsiness; headache; nausea; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, pain, or tingling of your hands, feet, arms, legs, or around the mouth or lips; calf pain or tenderness; chest pain; dark urine; decreased sexual ability; eye pain or vision changes; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hearing changes or hearing loss; mood or mental changes (eg, depression, suicidal thoughts or actions); mouth sores or irritation; neck pain or stiffness; pain or swelling in the arms or legs; red, swollen, blistered, or peeling skin; ringing in the ears or hearing changes; seizures; severe tiredness or weakness; shortness of breath; stiff neck; tremor; unusual bruising or bleeding; unusual swelling.

By body system

Nervous system side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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

Endocrine side effects

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

Other side effects

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

Ocular side effects

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

Psychiatric side effects

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

Renal side effects

Renal side effects have included acute renal failure and oliguria.

Hypersensitivity side effects

Hypersensitivity side effects have included allergic reaction.

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