Thalomid Side Effects

Generic Name: thalidomide

Please note - some side effects for Thalomid 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 Thalomid - for the Consumer

Thalomid

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 Thalomid:

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.

Thalomid Side Effects - for the Professional

Thalomid

The most serious toxicity associated with thalidomide is its documented human teratogenicity. The risk of severe birth defects, primarily phocomelia or death to the fetus, is extremely high during the critical period of pregnancy. The critical period is estimated, depending on the source of information, to range from 35 to 50 days after the last menstrual period. The risk of other potentially severe birth defects outside this critical period is unknown, but may be significant. Based on present knowledge, thalidomide must not be used at any time during pregnancy.

Because thalidomide is present in the semen of patients receiving the drug, males receiving thalidomide must always use a latex condom during any sexual contact with women of childbearing potential.

Thalidomide is associated with drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and HIV viral load increase.

Hypersensitivity to Thalomid® (thalidomide) and bradycardia in patients treated with thalidomide have been reported.

Somnolence, dizziness, and rash are the most commonly observed adverse events associated with the use of thalidomide. Thalidomide has been studied in controlled and uncontrolled clinical trials in patients with multiple myeloma and ENL and in people who are HIV-seropositive. In addition, thalidomide has been administered investigationally for more than 20 years in numerous indications. Adverse event profiles from these uses are summarized in the sections that follow.

Other Adverse Events

Due to the nature of the longitudinal data that form the basis of this product’s safety evaluation, no determination has been made of the causal relationship between the reported adverse events listed below and thalidomide. These lists are of various adverse events noted by investigators in patients to whom they had administered thalidomide under various conditions. The use of thalidomide may not limit disease progression and/or death.

Adverse Events in Multiple Myeloma Controlled Clinical Trial

The safety analysis was conducted on 204 patients who received study drug in the randomized trial. Table 6 lists the most common treatment–emergent signs and symptoms (occurring at ≥ 10%) that were observed. The most frequently reported adverse events were constipation, sensory neuropathy, confusion, hypocalcemia, edema, dyspnea, thrombosis/embolism, and rash/desquamation (occurring in ≥20% of patients and with a frequency of ≥ 10% in patients treated with Thalomid® (thalidomide)/dexamethasone compared with dexamethasone alone).

Twenty-three percent of patients (47/204) discontinued due to adverse events; thirty percent (31/102) from the Thalomid® (thalidomide)/dexamethasone arm and sixteen percent (16/102) from the dexamethasone alone arm.

Incidence in ENL Controlled Clinical Trials

Table 7 lists treatment-emergent signs and symptoms that occurred in Thalomid® (thalidomide)-treated patients in controlled clinical trials in ENL. Doses ranged from 50 to 300 mg/day. All adverse events were mild to moderate in severity, and none resulted in discontinuation. Table 7 also lists treatment-emergent adverse events that occurred in at least three of the Thalomid® (thalidomide)-treated HIV-seropositive patients who participated in an 8-week, placebo-controlled clinical trial. Events that were more frequent in the placebo-treated group are not included.

Other Adverse Events Observed in ENL Patients

Thalidomide in doses up to 400 mg/day has been administered investigationally in the United States over a 19-year period in 1465 patients with ENL. The published literature describes the treatment of an additional 1678 patients. To provide a meaningful estimate of the proportion of the individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using a modified COSTART dictionary/terminology. These categories are used in the listing below. All reported events are included except those already listed in the previous table. Due to the fact that these data were collected from uncontrolled studies, the incidence rate cannot be determined. As mentioned previously, no causal relationship between thalidomide and these events can be conclusively determined at this time. These are reports of all adverse events noted by investigators in patients to whom they had administered thalidomide.

Body as a Whole: Abdomen enlarged, fever, photosensitivity, upper extremity pain.

Cardiovascular System: Bradycardia, hypertension, hypotension, peripheral vascular disorder, tachycardia, vasodilation.

Digestive System: Anorexia, appetite increase/weight gain, dry mouth, dyspepsia, enlarged liver, eructation, flatulence, increased liver function tests, intestinal obstruction, vomiting.

Hemic and Lymphatic: ESR decrease, eosinophilia, granulocytopenia, hypochromic anemia, leukemia, leukocytosis, leukopenia, MCV elevated, RBC abnormal, spleen palpable, thrombocytopenia.

Metabolic and Endocrine: ADH inappropriate, amyloidosis, bilirubinemia, BUN increased, creatinine increased, cyanosis, diabetes, edema, electrolyte abnormalities, hyperglycemia, hyperkalemia, hyperuricemia, hypocalcemia, hypoproteinemia, LDH increased, phosphorus decreased, SGPT increased.

Muscular Skeletal: Arthritis, bone tenderness, hypertonia, joint disorder, leg cramps, myalgia, myasthenia, periosteal disorder.

Nervous System: Abnormal thinking, agitation, amnesia, anxiety, causalgia, circumoral paresthesia, confusion, depression, euphoria, hyperesthesia, insomnia, nervousness, neuralgia, neuritis, neuropathy, paresthesia, peripheral neuritis, psychosis.

Respiratory System: Cough, emphysema, epistaxis, pulmonary embolus, rales, upper respiratory infection, voice alteration.

Skin and Appendages: Acne, alopecia, dry skin, eczematous rash, exfoliative dermatitis, ichthyosis, perifollicular thickening, skin necrosis, seborrhea, sweating, urticaria, vesiculobullous rash.

Special Senses: Amblyopia, deafness, dry eye, eye pain, tinnitus.

Urogenital: Decreased creatinine clearance, hematuria, orchitis, proteinuria, pyuria, urinary frequency.

Other Adverse Events Observed in HIV-seropositive Patients

In addition to controlled clinical trials, Thalomid® (thalidomide) has been used in uncontrolled studies in 145 patients. Less frequent adverse events that have been reported in these HIV-seropositive patients treated with Thalomid® (thalidomide) were grouped into a smaller number of standardized categories using modified COSTART dictionary/terminology and these categories are used in the listing below. Adverse events that have already been included in the tables and narrative above, or that are too general to be informative are not listed.

Body as a Whole: Ascites, AIDS, allergic reaction, cellulitis, chest pain, chills and fever, cyst, decreased CD4 count, facial edema, flu syndrome, hernia, thyroid hormone level altered, moniliasis, photosensitivity reaction, sarcoma, sepsis, viral infection.

Cardiovascular System: Angina pectoris, arrhythmia, atrial fibrillation, bradycardia, cerebral ischemia, cerebrovascular accident, congestive heart failure, deep thrombophlebitis, heart arrest, heart failure, hypertension, hypotension, murmur, myocardial infarct, palpitation, pericarditis, peripheral vascular disorder, postural hypotension, syncope, tachycardia, thrombophlebitis, thrombosis.

Digestive System: Cholangitis, cholestatic jaundice, colitis, dyspepsia, dysphagia, esophagitis, gastroenteritis, gastrointestinal disorder, gastrointestinal hemorrhage, gum disorder, hepatitis, pancreatitis, parotid gland enlargement, periodontitis, stomatitis, tongue discoloration, tooth disorder.

Hemic and Lymphatic: Aplastic anemia, macrocytic anemia, megaloblastic anemia, microcytic anemia.

Metabolic and Endocrine: Avitaminosis, bilirubinemia, dehydration, hypercholesteremia, hypoglycemia, increased alkaline phosphatase, increased lipase, increased serum creatinine, peripheral edema.

Muscular Skeletal: Myalgia, myasthenia.

Nervous System: Abnormal gait, ataxia, decreased libido, decreased reflexes, dementia, dysesthesia, dyskinesia, emotional lability, hostility, hypalgesia, hyperkinesia, incoordination, meningitis, neurologic disorder, tremor, vertigo.

Respiratory System: Apnea, bronchitis, lung disorder, lung edema, pneumonia (including Pneumocystis carinii pneumonia), rhinitis.

Skin and Appendages: Angioedema, benign skin neoplasm, eczema, herpes simplex, incomplete Stevens-Johnson syndrome, nail disorder, pruritus, psoriasis, skin discoloration, skin disorder.

Special Senses: Conjunctivitis, eye disorder, lacrimation disorder, retinitis, taste perversion.

Other Adverse Events Observed in Post-Marketing Use

Cardiovascular System: Cardiac arrhythmias including atrial fibrillation, bradycardia, tachycardia, sick sinus syndrome and EKG abnormalities.

Digestive System: Intestinal perforation.

Metabolic and Endocrine: Electrolyte imbalance including hypercalcemia or hypocalcemia, hyperkalemia and hypokalemia, hyponatremia, hypothyroidism, and increased alkaline phosphatase, tumor lysis syndrome.

Nervous System: Changes in mental status or mood including depression and suicide attempts, disturbances in consciousness including lethargy, syncope, loss of consciousness or stupor, seizures including grand mal convulsions and status epilepicus.

Skin and Appendages: Erythema multiforme.

Hemic and Lymphatic: Decreased white blood cell counts including neutropenia and febrile neutropenia, changes in prothrombin time.

Respiratory System: Pleural effusion.

Other Adverse Events in the Published Literature or Reported from Other Sources

The following additional events have been identified either in the published literature or from spontaneous reports from other sources: acute renal failure, amenorrhea, aphthous stomatitis, bile duct obstruction, carpal tunnel, chronic myelogenous leukemia, diplopia, dysesthesia, dyspnea, enuresis, erythema nodosum, erythroleukemia, foot drop, galactorrhea, gynecomastia, hangover effect, hypomagnesemia, hypothyroidism, lymphedema, lymphopenia, metrorrhagia, migraine, myxedema, nodular sclerosing Hodgkin’s disease, nystagmus, oliguria, pancytopenia, petechiae, purpura, Raynaud’s syndrome, stomach ulcer, and suicide attempt.

Side Effects by Body System

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

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.

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

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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