Summary

Commonly reported side effects of thalidomide include: asthenia. Continue reading for a comprehensive list of adverse effects.

Applies to thalidomide: oral capsule.

Serious side effects of Thalidomide

Along with its needed effects, thalidomide 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
• black, tarry stools
• chest pain
• chills
• confusion
• cough
• dizziness or lightheadedness
• dry mouth
• fainting
• fast heartbeat
• fever
• irregular heartbeat
• irritability
• loss of taste
• lower back or side pain
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle weakness
• nervousness
• numbness and tingling around the mouth, fingertips, or feet
• pain in the chest, groin, or legs, especially the calves
• pain, redness, or swelling in the arm or leg
• painful or difficult urination
• pale skin
• peeling and loosening of the skin
• restlessness
• seizures
• severe, sudden headache
• skin rash
• shakiness in the legs, arms, hands, or feet
• slurred speech
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach cramps
• sudden, unexplained shortness of breath
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• swollen glands
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• tingling, burning, numbness, or pain in the hands, arms, feet, or legs
• trembling or shaking of hands or feet
• trouble sleeping
• troubled breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision changes

Rare

• Blood in the urine
• decreased urination

Incidence not known

• Bleeding gums
• blistering of the skin
• blood in the stools
• difficulty with speaking
• inability to move the arms, legs, or facial muscles
• inability to speak
• itching skin
• muscle jerking of the arms and legs
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• slow speech
• sudden loss of consciousness

Other side effects of Thalidomide

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
• dry skin
• diarrhea
• dizziness
• drowsiness
• loss of appetite
• nausea
• stomach pain
• weight changes

Less common

• Headache
• increased appetite

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.^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

Ocular

Common (1% to 10%): Blurred vision

Frequency not reported: Amblyopia, dry eye, eye pain

Postmarketing reports: Diplopia, nystagmus^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity/allergic reactions, angioedema^[Ref]

Immunologic

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

Postmarketing reports: Viral infections^[Ref]

Oncologic

Frequency not reported: Acute myeloid leukemia, myelodysplastic syndromes

Postmarketing reports: Chronic myelogenous leukemia, nodular sclerosing Hodgkin's disease, erythroleukemia^[Ref]

Renal

Frequency not reported: Increased BUN, increased creatinine

Postmarketing reports: Renal failure, acute renal failure^[Ref]