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Thalomid Side Effects

Generic name: thalidomide

Medically reviewed by Last updated on Apr 20, 2022.

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.


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

For the Consumer

Applies to thalidomide: oral capsule


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.

Side effects requiring immediate medical attention

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
  • 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


  • 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

Side effects not requiring immediate medical attention

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

Less common

  • Headache
  • increased appetite

For Healthcare Professionals

Applies to thalidomide: oral capsule


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]


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]


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]


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]


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]


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]


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]


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]


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]


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]


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]


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]


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]


Common (1% to 10%): Blurred vision

Frequency not reported: Amblyopia, dry eye, eye pain

Postmarketing reports: Diplopia, nystagmus[Ref]


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


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

Postmarketing reports: Viral infections[Ref]


Frequency not reported: Acute myeloid leukemia, myelodysplastic syndromes

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


Frequency not reported: Increased BUN, increased creatinine

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


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Further information

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.