Medical Editor: John P. Cunha, DO, FACOEP
What Is Thalomid?
Thalomid (thalidomide) is an immunomodulatory agent used to treat and prevent the debilitating and disfiguring skin sores caused by erythema nodosum leprosum (ENL), an inflammatory complication of leprosy. Thalomid is also used together with another medicine called dexamethasone to treat multiple myeloma (bone marrow cancer).
What Are Side Effects of Thalomid?
Common side effects of Thalomid include:
- muscle weakness,
- dry skin,
- tremors or shaking,
- bone pain,
- sleep problems (insomnia),
- nausea, or
- loss of appetite.
Thalomid may cause possibly severe nerve damage, which may be permanent. This may occur during treatment or after treatment with Thalomid has stopped. Tell your doctor if you develop any of the following symptoms while taking Thalomid:
- numbness/tingling/pain/burning in the feet or hands,
- muscle weakness or cramps, or
- a feeling of tightness in the feet.
Dosage for Thalomid
Dose and treatment regimen depends on the condition being treated.
What Drugs, Substances, or Supplements Interact with Thalomid?
Thalomid may interact with cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety, hormonal birth control, HIV medicines, griseofulvin, rifampin, rifabutin, phenytoin, or carbamazepine. Tell your doctor all prescription and over-the-counter medications you use.
Thalomid During Pregnancy and Breastfeeding
Thalomid must not be used during pregnancy due to the risk of severe birth defects and other serious, sometimes fatal harm to a fetus. If you are female and become pregnant or think you may be pregnant, if your period is late or you have unusual menstrual bleeding, or if you stop using 2 forms of birth control, stop taking thalidomide and tell your doctor. If you are male and have had unprotected sex with a woman who can become pregnant, or if you think your sexual partner may be pregnant, tell both of your doctors. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.
Our Thalomid (thalidomide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Call your doctor at once if you have:
- numbness, tingling, or burning pain in your hands or feet;
- slow heartbeats, shallow breathing, severe drowsiness, feeling like you might pass out;
- severe or ongoing constipation;
- a seizure (convulsions);
- signs of bleeding--easy bruising, nosebleeds, bleeding gums, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- signs of a stroke or blood clot--sudden numbness or weakness, problems with vision or speech, chest pain, shortness of breath, swelling or redness in an arm or leg;
- heart attack symptoms--chest pain spreading to your jaw or shoulder, nausea, sweating;
- low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores; or
- signs of tumor cell breakdown--confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.
Your thalidomide doses may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- low blood cell counts;
- headache, dizziness, drowsiness, weakness, tired feeling;
- anxiety, agitation, confusion;
- numbness, tremors, muscle weakness;
- nausea, loss of appetite, constipation;
- weight gain or loss;
- swelling, trouble breathing;
- rash, dry or peeling skin; or
- low calcium level--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Thalomid (Thalidomide)
The following clinically significant adverse reactions are described in detail in other labeling sections:
- Teratogenicity [see BOX WARNING, WARNINGS AND PRECAUTIONS, and PATIENT INFORMATION]
- Venous and Arterial Thromboembolism [see BOX WARNING, WARNINGS AND PRECAUTIONS, and PATIENT INFORMATION]
- Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see WARNINGS AND PRECAUTIONS]
- Drowsiness and Somnolence [see WARNINGS AND PRECAUTIONS]
- Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
- Dizziness and Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
- Neutropenia [see WARNINGS AND PRECAUTIONS]
- Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
- Increased HIV Viral Load [see WARNINGS AND PRECAUTIONS]
- Bradycardia [see WARNINGS AND PRECAUTIONS]
- Severe Cutaneous Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Most patients taking THALOMID can be expected to experience adverse reactions.
Adverse Reactions In Multiple Myeloma Controlled Clinical Trials
The safety analyses were conducted in two controlled clinical studies (Study 1 and Study 2). The safety analysis in Study 1 was conducted on 204 patients who received treatment. Table 1 lists the most common adverse reactions (≥ 10%). The most frequently reported adverse reactions were fatigue, hypocalcemia, edema, constipation, sensory neuropathy, dyspnea, muscle weakness, leukopenia, neutropenia, rash/desquamation, confusion, anorexia, nausea, anxiety/agitation, tremor, fever, weight loss, thrombosis/embolism, neuropathy-motor, weight gain, dizziness, and dry skin.
Twenty-three percent of patients (47/204) discontinued due to adverse reactions; 30% (31/102) from the THALOMID/dexamethasone arm and 16% (16/102) from the dexamethasone alone arm.
Table 1: Adverse Reactions Reported in ≥10% of Patients in the THALOMID/Dexamethasone Arm (Study 1 - Safety Population; N=204)
|Thal + Dex*
|Metabolic/Laboratory||97 (95)||33 (32)||96 (94)||30 (29)|
|Hypocalcemia||73 (72)||11 (11)||60 (59)||5 (5)|
|Neurology||92 (90)||30 (29)||76 (74)||18 (18)|
|Neuropathy-sensory||55 (54)||4 (4)||28 (28)||1 (1)|
|Confusion||29 (28)||9 (9)||12 (12)||3 (3)|
|Anxiety/agitation||26 (26)||1 (1)||14 (14)||3 (3)|
|Tremor||26 (26)||1 (1)||6 (6)||0 (0)|
|Neuropathy-motor||22 (22)||8 (8)||16 (16)||5 (5)|
|Dizziness/ lightheadedness||20 (20)||1 (1)||14 (14)||0 (0)|
|Depressed level of consciousness||16 (16)||3 (3)||3 (3)||3 (3)|
|Constitutional Symptoms||91 (89)||19 (19)||84 (82)||16 (16)|
|Fatigue||81 (79)||17 (17)||72 (71)||13 (13)|
|Fever||24 (24)||1 (1)||20 (20)||3 (3)|
|Weight loss||23 (23)||1 (1)||21 (21)||2 (2)|
|Weight gain||22 (22)||1 (1)||13 (13)||0 (0)|
|Blood/Bone Marrow||88 (86)||29 (29)||96 (94)||19 (19)|
|Leukocytes (decreased)||36 (35)||6 (6)||30 (29)||3 (3)|
|Neutrophils (decreased)||32 (31)||10 (10)||24 (24)||10 (10)|
|Gastrointestinal||83 (81)||22 (22)||70 (69)||8 (8)|
|Constipation||56 (55)||8 (8)||29 (28)||1 (1)|
|Anorexia||29 (28)||4 (4)||25 (24)||2 (2)|
|Nausea||29 (28)||5 (5)||23 (22)||1 (1)|
|Mouth dryness||12 (12)||1 (1)||6 (6)||0 (0)|
|Cardiovascular||70 (69)||37 (36)||60 (59)||21 (21)|
|Edema||58 (56)||6 (6)||47 (46)||4 (4)|
|Thrombosis/embolism||23 (22)||21 (21)||5 (5)||5 (5)|
|Pain||64 (63)||10 (10)||66 (65)||15 (15)|
|Myalgia||17 (17)||0 (0)||14 (14)||1 (1)|
|Arthralgia||13 (13)||0 (0)||10 (10)||2 (2)|
|Pulmonary||52 (51)||19 (19)||51 (50)||20 (20)|
|Dyspnea||43 (42)||13 (13)||32 (31)||15 (15)|
|Dermatology/Skin||48 (47)||5 (5)||35 (34)||2 (2)|
|Rash/desquamation||31 (30)||4 (4)||18 (18)||2 (2)|
|Dry skin||21 (21)||0 (0)||11 (11)||0 (0)|
|Hepatic||47 (46)||7 (7)||45 (44)||4 (4)|
|Bilirubin||14 (14)||2 (2)||10 (10)||2 (2)|
|Musculoskeletal||42 (41)||9 (9)||41 (40)||14 (14)|
|Muscle weakness||41 (40)||6 (6)||38 (37)||13 (13)|
|* Treatment-emergent adverse reactions reported in ≥10% of patients in THALOMID/dexamethasone arm and with a ≥1% difference in the THALOMID/dexamethasone arm compared to the dexamethasone alone arm.|
The safety analysis in Study 2 was conducted on 466 patients who received treatment. Table 2 lists the most common adverse reactions (≥10%) that were observed. Table 3 lists the most common Grade 3/4 adverse reactions (occurring at >2%) that were observed. The adverse reactions most often reported by patients treated with THALOMID/dexamethasone were constipation, peripheral edema, tremor, asthenia, dizziness and fatigue. Adverse reactions with a frequency at least 2-fold higher in the THALOMID/dexamethasone group than in the placebo/dexamethasone group include constipation, tremor, deep vein thrombosis and peripheral sensory neuropathy.
Twenty-six percent of patients (121/466) discontinued due to adverse reactions; 37% (86/234) from the THALOMID/dexamethasone arm and 15% (35/232) from the placebo/dexamethasone arm.
Table 2: Adverse Reactions Reported in ≥10% of Patients in the THALOMID/Dexamethasone Arm (Study 2 - Safety Population; N=466)
|Patients with at least 1 Adverse Reaction||233 (99)||230 (99)|
|General Disorders and Administration Site Conditions||176 (75)||149 (64)|
|Edema peripheral||80 (34)||57 (25)|
|Asthenia||56 (24)||47 (20)|
|Fatigue||50 (21)||36 (16)|
|Edema NOS||31 (13)||19 (8)|
|Gastrointestinal Disorders||162 (69)||149 (64)|
|Constipation||116 (50)||49 (21)|
|Nausea||30 (13)||27 (12)|
|Dyspepsia||27 (11)||21 (9)|
|Nervous System Disorders||161 (69)||138 (60)|
|Tremor||62 (26)||29 (12)|
|Dizziness||51 (23)||32 (14)|
|Paresthesia||27 (12)||15 (6)|
|Peripheral sensory neuropathy||24 (10)||12 (5)|
|Infections and Infestations||139 (59)||138 (60)|
|Pneumonia NOS||35 (15)||28 (12)|
|Psychiatric Disorders||90 (38)||97 (42)|
|Anxiety||27 (12)||22 (10)|
|Depression||24 (10)||19 (8)|
|Metabolism and Nutrition Disorders||96 (41)||89 (38)|
|Hyperglycemia NOS||36 (15)||32 (14)|
|Vascular Disorders||92 (39)||53 (23)|
|Deep vein thrombosis||30 (13)||4 (2)|
|NOS = not otherwise specified.
* All adverse reactions reported in ≥10% of patients in THALOMID/dexamethasone arm and with a ≥1% difference in proportion of patients between the THALOMID/dexamethasone arm compared to the placebo/dexamethasone arm.
Table 3: Grade 3/4 Adverse Reactions Reported in >2% of Patients in the THALOMID/Dexamethasone Arm (Study 2 - Safety Population; N=466)
|Infections and Infestations||50 (21)||36 (16)|
|Pneumonia NOS||17 (7)||14 (6)|
|Bronchopneumonia NOS||7 (3)||3 (1)|
|General Disorders and Administration Site Conditions||44 (19)||26 (11)|
|Asthenia||11 (5)||4 (2)|
|Metabolism and Nutrition Disorders||33 (14)||34 (15)|
|Hypokalemia||7 (3)||3 (1)|
|Nervous System Disorders||47 (20)||20 (9)|
|Syncope||8 (3)||1 (<1)|
|Peripheral neuropathy NOS||8 (3)||0 (0)|
|Cerebrovascular accident||6 (3)||1 (<1)|
|Cardiac Disorders||35 (15)||27 (11)|
|Atrial fibrillation||11 (5)||8 (3)|
|Myocardial ischemia||6 (3)||2 (1)|
|Vascular Disorders||42 (18)||14 (6)|
|Deep vein thrombosis||27 (12)||4 (2)|
|Gastrointestinal Disorders||26 (11)||22 (10)|
|Constipation||7 (3)||2 (1)|
|Investigations||21 (9)||21 (9)|
|Weight increased||8 (3)||4 (2)|
|Blood and Lymphatic System Disorders||24 (10)||17 (7)|
|Neutropenia||8 (3)||6 (3)|
|Respiratory, Thoracic, and Mediastinal Disorders||27 (12)||13 (6)|
|Pulmonary embolism||16 (7)||4 (2)|
|Psychiatric Disorders||19 (8)||8 (3)|
|Anxiety||5 (2)||3 (1)|
|Confusional state||5 (2)||2 (1)|
|Ear and Labyrinth Disorders||6 (3)||0 (0)|
|Vertigo||5 (2)||0 (0)|
|NOS = not otherwise specified.
* All Grade 3/4 adverse reactions with >2% of patients in THALOMID/dexamethasone arm and with a higher frequency in the THALOMID/dexamethasone arm compared to the placebo/dexamethasone arm.
Less Common Adverse Reactions In Multiple Myeloma Controlled Clinical Trials
In Study 2, THALOMID in combination with dexamethasone in patients with multiple myeloma, the following adverse reactions not described above were reported1:
Gastrointestinal disorders: Vomiting NOS, dry mouth, peritonitis, diverticular perforation
Nervous system disorders: Somnolence, hypoesthesia, polyneuropathy NOS, transient ischemic attack
Respiratory, thoracic, and mediastinal disorders: Bronchitis NOS
Psychiatric disorders: Mood alteration NOS
Vascular disorders: Hypotension NOS, orthostatic hypotension
Cardiac disorders: Bradycardia NOS
Eye disorders: Blurred vision
1All adverse reactions with ≥3% of patients in THALOMID/dexamethasone arm and with a ≥1% difference in proportion of patients between the THALOMID/dexamethasone arm compared to the placebo/dexamethasone arm. All grade 3/4 and serious adverse reactions reported >2 patients in THALOMID/dexamethasone arm and with a percentage higher in the THALOMID/dexamethasone arm compared to the placebo/dexamethasone arm have been considered for possible inclusion. In any cases medical judgment has been applied for consideration of causality assessment.
Adverse Reactions In Erythema Nodosum Leprosum (ENL) Clinical Trials
Table 4 lists treatment-emergent signs and symptoms that occurred in THALOMID-treated patients in clinical trials in ENL. The most common adverse reactions (≥10%) reported in patients with ENL were somnolence, rash, headache. Doses ranged from 50 to 300 mg/day. All adverse reactions were mild to moderate in severity, and none resulted in discontinuation.
Table 4: Summary of Adverse Reactions (ARs) Reported in Celgene-sponsored Controlled Clinical Trials
|All ARs Reported in Patients with ENL||ARs Reported in ≥3 HIV-seropositive Patients|
|Body System/Adverse Reaction||THALOMID
50 to 300 mg/day
100 mg/day (N=36)
200 mg/day (N=32)
|Blood and Lymphatic||0||8 (22)||13 (41)||10 (29)|
|Anemia||0||2 (6)||4 (13)||3 (9)|
|Leukopenia||0||6 (17)||8 (25)||3 (9)|
|Lymphadenopathy||0||2 (6)||4 (13)||3 (9)|
|Body as a Whole||16 (67)||18 (50)||19 (59)||13 (37)|
|Abdominal pain||1 (4)||1 (3)||1 (3)||4 (11)|
|Accidental injury||1 (4)||2 (6)||0||1 (3)|
|Asthenia||2 (8)||2 (6)||7 (22)||1 (3)|
|Back pain||1 (4)||2 (6)||0||0|
|Chills||1 (4)||0||3 (9)||4 (11)|
|Facial edema||1 (4)||0||0||0|
|Fever||0||7 (19)||7 (22)||6 (17)|
|Headache||3 (13)||6 (17)||6 (19)||4 (11)|
|Infection||0||3 (8)||2 (6)||1 (3)|
|Neck pain||1 (4)||0||0||0|
|Neck rigidity||1 (4)||0||0||0|
|Pain||2 (8)||0||1 (3)||2 (6)|
|Digestive System||5 (21)||16 (44)||16 (50)||15 (43)|
|Anorexia||0||1 (3)||3 (9)||2 (6)|
|Constipation||1 (4)||1 (3)||3 (9)||0|
|Diarrhea||1 (4)||4 (11)||6 (19)||6 (17)|
|Dry mouth||0||3 (8)||3 (9)||2 (6)|
|Flatulence||0||3 (8)||0||2 (6)|
|Liver function tests multiple abnormalities||0||0||3 (9)||0|
|Nausea||1 (4)||0||4 (13)||1 (3)|
|Oral moniliasis||1 (4)||4 (11)||2 (6)||0|
|Tooth pain||1 (4)||0||0||0|
|Metabolic and Endocrine Disorders||1 (4)||8 (22)||12 (38)||8 (23)|
|Edema peripheral||1 (4)||3 (8)||1 (3)||0|
|Hyperlipidemia||0||2 (6)||3 (9)||1 (3)|
|SGOT increased||0||1 (3)||4 (13)||2 (6)|
|Nervous System||13 (54)||19 (53)||18 (56)||12 (34)|
|Dizziness||1 (4)||7 (19)||6 (19)||0|
|Insomnia||0||0||3 (9)||2 (6)|
|Nervousness||0||1 (3)||3 (9)||0|
|Paresthesia||0||2 (6)||5 (16)||4 (11)|
|Somnolence||9 (38)||13 (36)||12 (38)||4 (11)|
|Respiratory System||3 (13)||9 (25)||6 (19)||9 (26)|
|Pharyngitis||1 (4)||3 (8)||2 (6)||2 (6)|
|Rhinitis||1 (4)||0||0||4 (11)|
|Sinusitis||1 (4)||3 (8)||1 (3)||2 (6)|
|Skin and Appendages||10 (42)||17 (47)||18 (56)||19 (54)|
|Acne||0||4 (11)||1 (3)||0|
|Dermatitis fungal||1 (4)||2 (6)||3 (9)||0|
|Nail disorder||1 (4)||0||1 (3)||0|
|Pruritus||2 (8)||1 (3)||2 (6)||2 (6)|
|Rash||5 (21)||9 (25)||8 (25)||11 (31)|
|Rash maculopapular||1 (4)||6 (17)||6 (19)||2 (6)|
|Sweating||0||0||4 (13)||4 (11)|
|Urogenital System||2 (8)||6 (17)||2 (6)||4 (11)|
|Albuminuria||0||3 (8)||1 (3)||2 (6)|
|Hematuria||0||4 (11)||0||1 (3)|
|Impotence||2 (8)||1 (3)||0||0|
Other Adverse Reactions Observed In ENL Patients
THALOMID 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 reactions, 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. No causal relationship between THALOMID 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 THALOMID.
Blood and Lymphatic: ESR decrease, eosinophilia, granulocytopenia, hypochromic anemia, leukemia, leukocytosis, leukopenia, MCV elevated, RBC abnormal, spleen palpable, thrombocytopenia.
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.
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 Reactions Observed In HIV-Seropositive Patients
In addition to controlled clinical trials, THALOMID has been used in uncontrolled studies in 145 patients. Less frequent adverse reactions that have been reported in these HIV-seropositive patients treated with THALOMID were grouped into a smaller number of standardized categories using modified COSTART dictionary/terminology and these categories are used in the listing below. Adverse reactions that have already been included in the tables and narrative above, or that are too general to be informative are not listed.
Blood and Lymphatic: Aplastic anemia, macrocytic anemia, megaloblastic anemia, microcytic anemia.
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.
Metabolic and Endocrine: Avitaminosis, bilirubinemia, dehydration, hypercholesterolemia, 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.
The following additional adverse reactions have been identified during post approval use of THALOMID and are not already included in Clinical Trials Experience [see Clinical Trials Experience]. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic: Decreased white blood cell counts including febrile neutropenia, changes in prothrombin time, pancytopenia, chronic myelogenous leukemia, nodular sclerosing Hodgkin's disease, erythroleukemia, lymphedema, lymphopenia.
Body as a Whole: Hangover effect
Cardiovascular System: Sick sinus syndrome, EKG abnormalities, pulmonary hypertension.
Digestive System: Intestinal perforation, gastrointestinal perforations, bile duct obstruction, stomach ulcer, aphthous, stomatitis.
Ear and Labyrinthine Disorders: Hearing impairment.
Immune System Disorders: Hypersensitivity including anaphylaxis, solid organ transplant rejection.
Infections and infestations: Severe infections (e.g., fatal sepsis including septic shock), viral infections (including varicella zoster virus, cytomegalovirus, and hepatitis B virus reactivation) and progressive multifocal leukoencephalopathy (PML).
Metabolic and Endocrine: Electrolyte imbalance including hypercalcemia, hyponatremia and hypomagnesemia, hypothyroidism, increased alkaline phosphatase, tumor lysis syndrome, myxedema.
Nervous System: Changes in mental status or mood including suicide attempts, disturbances in consciousness including lethargy, loss of consciousness or stupor, seizures including grand mal convulsions and status epilepticus, Parkinson's disease, stroke, carpal tunnel, Raynaud's syndrome, migraine, foot drop.
Renal and Urinary Disorders: Renal failure, acute renal failure, oliguria, enuresis.
Reproductive System and Breast Disorders: amenorrhea, sexual dysfunction, galactorrhea, gynecomastia, metrorrhagia.
Respiratory System: Pleural effusion, interstitial lung disease.
Skin and Appendages: Erythema multiforme, erythema nodosum, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), purpura, petechiae.
Special Senses: Diplopia, nystagmus
Opioids, Antihistamines, Antipsychotics, Anti-Anxiety Agents, Or Other CNS Depressants (Including Alcohol)
The use of opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants concomitantly with THALOMID may cause an additive sedative effect and should be avoided.
Drugs Which Cause Bradycardia
The use of drugs which slow cardiac conduction concomitantly with THALOMID may cause an additive bradycardic effect and should be used with caution. Cardiovascular medications which may cause bradycardia include calcium channel blockers, beta blockers, alpha/beta-adrenergic blockers, and digoxin. Non-cardiac drugs that may cause bradycardia include H2 blockers (e.g., famotidine, cimetidine), lithium, tricyclic antidepressants and neuromuscular blockers (succinylcholine).
In 16 healthy men, the pharmacokinetic profile of a single 0.5 mg digoxin dose was similar with and without the coadministration of THALOMID 200 mg/day at steady state levels. The single dose of digoxin had no effect on the pharmacokinetic profile of THALOMID. The safety of long-term concomitant use of THALOMID and digoxin has not been evaluated.
Drugs Which Cause Peripheral Neuropathy
The use of drugs which cause peripheral neuropathy (e.g., bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol) can cause an additive effect and should be used with caution.
Hormonal contraceptives increase the risk of thromboembolism. It is not known whether concomitant use of hormonal contraceptives further increases the risk of thromboembolism with THALOMID.
In 10 healthy women, the pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of a single dose containing 1.0 mg of norethindrone acetate and 75 mcg of ethinyl estradiol were studied. The results were similar with and without coadministration of THALOMID 200 mg/day to steady-state levels.
In 13 healthy men, the pharmacokinetic profile and international normalized ratio (INR) of prothrombin time for warfarin, following a single oral dose of 25 mg, were similar with and without the coadministration of THALOMID 200 mg/day at steady-state levels. The single dose of warfarin had no effect on the pharmacokinetic profile of thalidomide.
Drugs That Interfere With Hormonal Contraceptives
Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements such as St. John's Wort with hormonal contraceptive agents may reduce the effectiveness of the contraception up to one month after discontinuation of these concomitant therapies. Therefore, females requiring treatment with one or more of these drugs must use two OTHER effective or highly effective methods of contraception while taking THALOMID.
Concomitant Therapies That May Increase The Risk Of Thromboembolism
Erythropoietic agents, or other agents that may increase the risk of thromboembolism, such as estrogen containing therapies, should be used with caution in multiple myeloma patients receiving THALOMID with dexamethasone [see WARNINGS AND PRECAUTIONS].
Drug Abuse And Dependence
Physical and psychological dependence has not been reported in patients taking THALOMID; however, as with other tranquilizers/hypnotics, thalidomide has been reported to result in habituation to its soporific effects.
Read the entire FDA prescribing information for Thalomid (Thalidomide)
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