Thalidomide Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 16, 2023.

Applies to thalidomide: oral capsule.

Important warnings This medicine can cause some serious health issues

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.

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]

Further information

Thalidomide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer