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Thalomid

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Thalomid

Thalomid Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Thalomid (thalidomide) is used to treat and prevent the debilitating and disfiguring skin sores caused by erythema nodosum leprosum (ENL), an inflammatory complication of leprosy. It is also used together with another medicine called dexamethasone to treat multiple myeloma (bone marrow cancer). It is an immunomodulatory agent. Common side effects include drowsiness, dizziness, constipation, weakness, and dry skin.

Dose and treatment regimen depends on the condition being treated. 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 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, breast-feeding 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Thalomid in Detail - Patient Information: Side Effects

Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Thalomid (Thalidomide) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Thalomid Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, constipation, weakness, and dry skin may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Thalidomide may cause possibly severe nerve damage, which may be permanent. This may occur during treatment or after treatment has stopped. Tell your doctor immediately if you develop any of the following symptoms: numbness/tingling/pain/burning in the feet or hands, muscle weakness/cramps, feeling of tightness in the feet.

People with multiple myeloma who are treated with this medication may rarely get other cancers (such as acute leukemia). Consult your doctor for more details.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., confusion, anxiety), shaking (tremor), shortness of breath, arm/leg swelling, fast/slow heartbeat, signs of infection (e.g., fever, persistent sore throat).

Get medical help right away if you have any very serious side effects, including: seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Thalomid (Thalidomide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Thalomid FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described in detail in other labeling sections:

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.

Clinical Trials Experience

Most patients taking thalidomide can be expected to experience adverse reactions.

Teratogenicity

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 or synthetic condom during any sexual contact with females of reproductive potential, even if he has undergone a successful vasectomy.

Venous and Arterial Thromboembolism

An increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism), ischemic heart disease (including myocardial infarction), and stroke have been reported in patients with multiple myeloma treated with thalidomide [see Venous and Arterial Thromboembolism].

Peripheral Neuropathy

Peripheral neuropathy is a very common, potentially severe, adverse reaction of treatment with thalidomide that may result in irreversible damage. Peripheral neuropathy generally occurs following chronic use over a period of months. However, reports following relatively short-term use also exist. Incidence of neuropathy events leading to discontinuation, dose reduction or interruption increases with cumulative dose and duration of therapy. Symptoms may occur some time after thalidomide treatment has been stopped and may resolve slowly or not at all.

Somnolence, dizziness, and rash are the most commonly observed adverse reactions associated with the use of thalidomide. Adverse event profiles from clinical trials are summarized in the sections that follow.

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 drug 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 Drug Reactions Reported in ≥ 10% of Patients in the THALOMID/Dexamethasone Arm (Study 1 - Safety Population; N=204)

Organ System Class/ Preferred Term Thal + Dex *
(N=102)
All Grades n (%)
Grade 3/4
n(%)
Dex Alone*
(N=102) All Grades
n (%)
Grade 3/4
n(%)
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 (18) 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 drug reactions ( ≥ 10%) that were observed. Table 3 lists the most common Grade 3/4 adverse drug 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 events; 37% (86/234) from the THALOMID/dexamethasone arm and 15% (35/232) from the placebo/dexamethasone arm.

Table 2: Adverse Drug Reactions Reported in ≥ 10% of Patients in the THALOMID/Dexamethasone Arm (Study 2 - Safety Population; N=466)

MedDRA System Organ Class/
Preferred Term
Thal/Dex
(N=234)*
n (%)
Placebo/Dex
(N=232)*
n (%)
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)
  Paraesthesia 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)
*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.
MedDRA = Medical Dictionary for Regulatory Activities; NOS = not otherwise specified.

Table 3: Grade 3/4 Adverse Drug Reactions Reported in > 2% of Patients in the THALOMID/Dexamethasone Arm (Study 2 - Safety Population; N=466)

MedDRA System Organ Class/
Preferred Term
THALOMID/Dex
(N=234)*
n (%)
Placebo/Dex
(N=232)*
n (%)
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)
*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.
MedDRA = Medical Dictionary for Regulatory Activities; NOS = not otherwise specified.

Less Common Adverse Drug Reactions in Multiple Myeloma Controlled Clinical Trials

In Study 2, THALOMID in combination with dexamethasone in patients with multiple myeloma, the following adverse drug reactions not described above were reported*:

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

* All 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 Events (AEs) Reported in Celgene-sponsored Controlled Clinical Trials

Body System/
Adverse Event
All AEs Reported in Patients with ENL AEs Reported in ≥ 3 HIV-seropositive Patients
Thalidomide
50 to 300 mg/day
(N=24)
100 mg/day
(N=36)
200 mg/day
(N=32)
Placebo
(N=35)
Body as a Whole 16 (66.7%) 18 (50.0%) 19 (59.4%) 13 (37.1%)
  Abdominal pain 1 (4.2%) 1 (2.8%) 1 (3.1%) 4 (11.4%)
  Accidental injury 1 (4.2%) 2 (5.6%) 0 1 (2.9%)
  Asthenia 2 (8.3%) 2 (5.6%) 7 (21.9%) 1 (2.9%)
  Back pain 1 (4.2%) 2 (5.6%) 0 0
  Chills 1 (4.2%) 0 3 (9.4%) 4 (11.4%)
  Facial edema 1 (4.2%) 0 0 0
  Fever 0 7 (19.4%) 7 (21.9%) 6 (17.1%)
  Headache 3 (12.5%) 6 (16.7%) 6 (18.7%) 4 (11.4%)
  Infection 0 3 (8.3%) 2 (6.3%) 1 (2.9%)
  Malaise 2 (8.3%) 0 0 0
  Neck pain 1 (4.2%) 0 0 0
  Neck rigidity 1 (4.2%) 0 0 0
  Pain 2 (8.3%) 0 1 (3.1%) 2 (5.7%)
Digestive System 5 (20.8%) 16 (44.4%) 16 (50.0%) 15 (42.9%)
  Anorexia 0 1 (2.8%) 3 (9.4%) 2 (5.7%)
  Constipation 1 (4.2%) 1 (2.8%) 3 (9.4%) 0
  Diarrhea 1 (4.2%) 4 (11.1%) 6 (18.7%) 6 (17.1%)
  Dry mouth 0 3 (8.3%) 3 (9.4%) 2 (5.7%)
  Flatulence 0 3 (8.3%) 0 2 (5.7%)
  Liver function tests multiple abnormalities 0 0 3 (9.4%) 0
  Nausea 1 (4.2%) 0 4 (12.5%) 1 (2.9%)
  Oral moniliasis 1 (4.2%) 4 (11.1%) 2 (6.3%) 0
  Tooth pain 1 (4.2%) 0 0 0
Hemic and Lymphatic 0 8 (22.2%) 13 (40.6%) 10 (28.6%)
  Anemia 0 2 (5.6%) 4 (12.5%) 3 (8.6%)
  Leukopenia 0 6 (16.7%) 8 (25.0%) 3 (8.6%)
  Lymphadenopathy 0 2 (5.6%) 4 (12.5%) 3 (8.6%)
Metabolic and Endocrine Disorders 1 (4.2%) 8 (22.2%) 12 (37.5%) 8 (22.9%)
  Edema peripheral 1 (4.2%) 3 (8.3%) 1 (3.1%) 0
  Hyperlipemia 0 2 (5.6%) 3 (9.4%) 1 (2.9%)
  SGOT increased 0 1 (2.8%) 4 (12.5%) 2 (5.7%)
Nervous System 13 (54.2%) 19 (52.8%) 18 (56.3%) 12 (34.3%)
  Agitation 0 0 3 (9.4%) 0
  Dizziness 1 (4.2%) 7 (19.4%) 6 (18.7%) 0
  Insomnia 0 0 3 (9.4%) 2 (5.7%)
  Nervousness 0 1 (2.8%) 3 (9.4%) 0
  Neuropathy 0 3 (8.3%) 0 0
  Paresthesia 0 2 (5.6%) 5 (15.6%) 4 (11.4%)
  Somnolence 9 (37.5%) 13 (36.1%) 12 (37.5%) 4 (11.4%)
  Tremor 1 (4.2%) 0 0 0
  Vertigo 2 (8.3%) 0 0 0
Respiratory System 3 (12.5%) 9 (25.0%) 6 (18.7%) 9 (25.7%)
  Pharyngitis 1 (4.2%) 3 (8.3%) 2 (6.3%) 2 (5.7%)
  Rhinitis 1 (4.2%) 0 0 4 (11.4%)
  Sinusitis 1 (4.2%) 3 (8.3%) 1 (3.1%) 2 (5.7%)
Skin and Appendages 10 (41.7%) 17 (47.2%) 18 (56.3%) 19 (54.3%)
  Acne 0 4 (11.1%) 1 (3.1%) 0
  Dermatitis fungal 1 (4.2%) 2 (5.6%) 3 (9.4%) 0
  Nail disorder 1 (4.2%) 0 1 (3.1%) 0
  Pruritus 2 (8.3%) 1 (2.8%) 2 (6.3%) 2 (5.7%)
  Rash 5 (20.8%) 9 (25.0%) 8 (25.0%) 11 (31.4%)
  Rash maculopapular 1 (4.2%) 6 (16.7%) 6 (18.7%) 2 (5.7%)
  Sweating 0 0 4 (12.5%) 4 (11.4%)
Urogenital System 2 (8.3%) 6 (16.7%) 2 (6.3%) 4 (11.4%)
  Albuminuria 0 3 (8.3%) 1 (3.1%) 2 (5.7%)
  Hematuria   0 4 (11.1%) 0 1 (2.9%)
  Impotence 2 (8.3%) 1 (2.8%) 0 0

Other Adverse Events 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 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. 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 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 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 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.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of THALOMID. 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.

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

Digestive System: Intestinal perforation, gastrointestinal perforations, intestinal obstruction.

Metabolic and Endocrine: Electrolyte imbalance including hypercalcemia or hypocalcemia, hyperkalemia and hypokalemia, hyponatremia, hypothyroidism, 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 epilepticus, Parkinson's disease, stroke.

Skin and Appendages: Erythema multiforme, toxic epidermal necrolysis.

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

Respiratory System: Pleural effusion.

Reproductive System and Breast Disorders: amenorrhea, sexual dysfunction.

Immune System Disorders: Hypersensitivity, angioedema/urticaria.

Ear and Labyrinthine Disorders: Hearing impairment/deafness.

Renal and Urinary Disorders: Renal failure.

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, suicide attempt, interstitial lung disease and severe infections (e.g., fatal sepsis including septic shock).

Read the entire FDA prescribing information for Thalomid (Thalidomide) »

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Thalomid - User Reviews

Thalomid User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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