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Thalomid

Generic Name: thalidomide (tha LID oh mide)
Brand Names: Thalomid
Thalomid is used to treat skin sores caused by erythema nodosum leprosum, a complication of leprosy. Learn about side effects, interactions and indications.
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Drug Information:
Thalomid (thalidomide) affects the immune system. It promotes immune responses to help slow tumor growth. Thalomid is used together with dexamethasone to treat multiple myeloma (bone marrow cancer). Thalomid is also used to treat and prevent moderate to severe skin lesions caused by leprosy. Thalomid is available only in a 28-day supply from a certified pharmacy under a special program called Thalomid REMS. You must be registered in the program and agree to use birth control as required. You will be limited to a 28-day supply of medicine each time your prescription is refilled. Learn more

Thalomid Side Effects

Thalomid Side Effects

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.

In Summary

Common side effects of Thalomid include: asthenia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to thalidomide: oral capsule

Warning

Oral route (Capsule)

Thalidomide can cause severe birth defects or embryofetal death, even with 1 dose, if taken during pregnancy. Thalidomide distribution is restricted through the THALOMID REMS(TM) program (formerly known as the S.T.E.P.S.® program). The use of thalidomide in multiple myeloma patients results in an increased risk of VTE , such as DVT and pulmonary embolism. Coadministration of dexamethasone increases this risk. Monitor for thromboembolism and consider thromboprophylaxis for individualized cases.

Along with its needed effects, thalidomide (the active ingredient contained in Thalomid) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking thalidomide:

More common

  • Anxiety
  • chest pain
  • cough
  • dizziness or lightheadedness
  • fainting
  • fast heartbeat
  • muscle weakness
  • pain, redness, or swelling in the arm or leg
  • tingling, burning, numbness, or pain in the hands, arms, feet, or legs
  • troubled breathing

Rare

  • Blood in the urine
  • decreased urination
  • fever, alone or with chills and sore throat
  • irregular heartbeat
  • low blood pressure
  • skin rash

Incidence not known

  • Black, tarry stools
  • bleeding gums
  • blistering of the skin
  • blood in the stools
  • confusion
  • difficulty with speaking
  • double vision
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • itching skin
  • muscle jerking of the arms and legs
  • peeling and loosening of the skin
  • pinpoint red spots on the skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • seizures
  • slow speech
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden loss of consciousness
  • unusual bleeding or bruising

Some side effects of thalidomide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Constipation
  • diarrhea
  • drowsiness
  • nausea
  • stomach pain

Less common

  • Dry skin
  • dryness of the mouth
  • headache
  • increased appetite
  • mood changes

For Healthcare Professionals

Applies to thalidomide: oral capsule

General

In uncontrolled studies with HIV-seropositive patients, there were reports of adverse events (e.g., increased HIV viral load, decreased CD4 count, AIDS) that were not reported in other patient populations; consult the manufacturer product information.

Metabolic

Very common (10% or more): Hypocalcemia (95%), anorexia (28%), weight loss (23%), weight gain (22%)

Common (1% to 10%): Hypokalemia, hyperlipidemia

Rare (less than 0.1%): Increased appetite

Frequency not reported: Increased appetite, electrolyte abnormalities, hyperkalemia, hypocalcemia, hypoproteinemia, increased lactate dehydrogenase (LDH), decreased phosphorus

Postmarketing reports: Tumor lysis syndrome, hypercalcemia, hyponatremia, hypomagnesemia

Other

Very common (10% or more): Fatigue (79%), edema (56%), peripheral edema (34%), asthenia (24%), pyrexia/fever (24%)

Common (1% to 10%): Accidental injury, chills, infection, pain, malaise, weakness, lethargy

Frequency not reported: Tinnitus, palpable spleen

Postmarketing reports: Sepsis, septic shock, hearing impairment/deafness, hangover effect

Gastrointestinal

Very common (10% or more): Constipation (55%), nausea (28%), diarrhea (18.7%), dry mouth (12%), oral moniliasis (11.1%), dyspepsia (11%)

Common (1% to 10%): Abdominal pain, vomiting, flatulence

Uncommon (0.1% to 1%): Diverticular perforation, peritonitis

Very rare (less than 0.01%): Intestinal obstruction

Frequency not reported: Enlarged abdomen, eructation

Postmarketing reports: Gastrointestinal (GI) perforation, GI hemorrhage, pancreatitis, bile duct obstruction, stomach ulcer, aphthous stomatitis

Nervous system

Very common (10% or more): Sensory neuropathy (54%), drowsiness/somnolence/sedation (37.5%), tremor (26%), dizziness/lightheadedness (23%), motor neuropathy (22%), headache (18.7%), depressed level of consciousness (16%), paresthesia (15.6%), sensory peripheral neuropathy (10%)

Common (1% to 10%): Cerebrovascular accident/event, syncope, vertigo, abnormal coordination, transient ischemic event, ataxia, amnesia, causalgia, circumoral paresthesia, hyperesthesia, dysesthesia

Frequency not reported: Neuritis, peripheral neuritis, neuralgia, hypertonia

Postmarketing reports: Seizures, convulsions, Parkinson's disease/worsening of Parkinson's disease symptoms, posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS), stupor, stroke, carpal tunnel, Raynaud's syndrome, migraine, foot drop

Hematologic

Very common (10% or more): Neutropenia (42.7%), decreased leukocytes (35%), decreased neutrophils (31%), leukopenia (25.8%), anemia (13.7%), lymphadenopathy (12.5%), lymphopenia (12.1%), thrombocytopenia (11.3%)

Very rare (less than 0.01%): Eosinophilia

Frequency not reported: Increased/decreased platelet count, decreased erythrocyte sedimentation rate (ESR), granulocytopenia, hypochromic anemia, leukocytosis, elevated mean corpuscular volume (MCV), abnormal red blood cell (RBC) count

Postmarketing reports: Febrile neutropenia, pancytopenia, decreased white blood cell (WBC) count, prothrombin time changes, lymphedema

Respiratory

Very common (10% or more): Dyspnea (42%), pneumonia (15%)

Common (1% to 10%): Bronchopneumonia, pulmonary embolism, pharyngitis, sinusitis, interstitial lung disease

Uncommon (0.1% to 1%): Bronchitis

Very rare (less than 0.01%): Bronchospasm

Frequency not reported: Cough, emphysema, epistaxis, rales, upper respiratory infection, voice alteration

Musculoskeletal

Very common (10% or more): Muscle weakness (40%), myalgia (17%), arthralgia (13%)

Common (1% to 10%): Muscle cramps

Frequency not reported: Upper extremity pain, arthritis, bone tenderness, joint disorder, leg cramps, myasthenia, periosteal disorder

Dermatologic

Very common (10% or more): Rash/desquamation (30%), rash (25%), dry skin (21%), maculopapular rash (18.7%), sweating (12.5%), acne (11.1%)

Common (1% to 10%): Fungal dermatitis, nail disorder, pruritus, toxic skin eruption, urticaria

Very rare (less than 0.01%): Severe skin reactions (Stevens-Johnson Syndrome, toxic epidermal necrolysis), facial edema, photosensitivity, alopecia, eczematous rash, exfoliative dermatitis, ichthyosis, perifollicular thickening, skin necrosis, seborrhea, sweating, vesiculobullous rash

Postmarketing reports: Erythema multiforme, erythema nodosum, purpura, petechiae

Psychiatric

Very common (10% or more): Confusion (28%), anxiety/agitation (26%), depression (10%)

Common (1% to 10%): Insomnia, nervousness, abnormal thinking, euphoria, impotence, altered mood/mood changes/mental status changes

Very rare (less than 0.01%): Decreased libido

Frequency not reported: Psychosis

Postmarketing reports: Sexual dysfunction, suicide attempts

Cardiovascular

Very common (10% or more): Thrombosis/embolism (22%), deep vein thrombosis (13%)

Common (1% to 10%): Atrial fibrillation, myocardial ischemia/infarction, bradycardia, cardiac failure, hypotension

Uncommon (0.1% to 1%): Orthostatic hypotension

Rare (less than 0.1%): Tachycardia, cardiac arrhythmia

Frequency not reported: Hypertension, peripheral vascular disorder, vasodilation, cyanosis

Postmarketing reports: Atrioventricular block, pulmonary hypertension, sick sinus syndrome, electrocardiogram (ECG) abnormalities

Endocrine

Very common (10% or more): Hyperglycemia (15%)

Very rare (less than 0.01%): Hypothyroidism, menstruation abnormalities, amenorrhea

Frequency not reported: Diabetes, inappropriate antidiuretic hormone (ADH)

Postmarketing reports: Myxedema, galactorrhea, gynecomastia

Hepatic

Very common (10% or more): Abnormal bilirubin level (14%), increased SGOT (12.5%)

Common (1% to 10%): Abnormal liver function tests

Frequency not reported: Enlarged liver, bilirubinemia, increased SGPT

Postmarketing reports: Increased alkaline phosphatase

Genitourinary

Very common (10% or more): Hematuria (11.1%)

Common (1% to 10%): Albuminuria

Frequency not reported: Hyperuricemia, proteinuria, pyuria, urinary frequency, orchitis

Postmarketing reports: Oliguria, enuresis, metrorrhagia

Ocular

Common (1% to 10%): Blurred vision

Frequency not reported: Amblyopia, dry eye, eye pain

Postmarketing reports: Diplopia, nystagmus

Hypersensitivity

Frequency not reported: Hypersensitivity/allergic reactions, angioedema

Immunologic

Frequency not reported: Viral reactivation (herpes zoster, hepatitis B, cytomegalovirus), increased HIV viral load/RNA levels, amyloidosis

Postmarketing reports: Viral infections

Oncologic

Frequency not reported: Acute myeloid leukemia, myelodysplastic syndromes

Postmarketing reports: Chronic myelogenous leukemia, nodular sclerosing Hodgkin's disease, erythroleukemia

Renal

Frequency not reported: Increased BUN, increased creatinine

Postmarketing reports: Renal failure, acute renal failure

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Thalomid