Thalidomide Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 11, 2025.

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:

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:

Precautions

It is very important that your doctor check your progress closely at regular visits to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for unwanted effects.

Women should take the necessary precautions to avoid pregnancy while taking thalidomide. Begin 2 forms of effective birth control together 4 weeks before starting treatment, during treatment, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Talk to your doctor about the most effective forms of birth control for you and your partner. Call your doctor right away if you think you are pregnant.

Women who can get pregnant must have a negative pregnancy test before starting treatment with this medicine. Pregnancy tests may be done weekly for the first month during treatment, and then every 2 to 4 weeks.

Men who are sexually active must protect their female partner from getting pregnant. Thalidomide will appear in the semen of male patients. If you are sexually active, you must use a latex or synthetic condom every time you have sex with a woman who could get pregnant. If you have had a vasectomy, you still have to use a latex condom during sex. You must use a condom during treatment, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Call your doctor right away if you think your sexual partner may be pregnant.

Do not donate blood or sperm while you are taking this medicine and for at least 4 weeks after your last dose.

You must not share this medicine with anyone, even someone who has similar symptoms.

This medicine may increase your risk of having blood clots, a heart attack, or stroke. Check with your doctor right away if you have shortness of breath, chest pain, or leg pain or swelling. These could be symptoms of blood clots. Symptoms of stroke include confusion, difficulty with speaking, double vision, inability to move the arms, legs, or facial muscles, or slow speech.

Do not receive pembrolizumab together with thalidomide and dexamethasone if you have multiple myeloma.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you feel lightheaded, getting up slowing after sitting or lying down may help.

Thalidomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause nerve damage. Check with your doctor right away if you have tingling, burning, numbness, or pain in your hands or feet. These could be symptoms of a nerve condition called peripheral neuropathy.

Check with your doctor right away if you have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Thalidomide may cause a serious type of reaction called tumor lysis syndrome in patients with multiple myeloma. Call your doctor right away if you have less urine than normal, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using thalidomide.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

For healthcare professionals

Applies to thalidomide: oral capsule.

General adverse events

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]

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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