Pomalidomide Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 22, 2024.

Applies to pomalidomide: oral capsule.

Precautions

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

Using this medicine while you are pregnant can harm your unborn baby. Pregnancy tests are required before and during treatment with this medicine. Women who are sexually active must use 2 forms of effective birth control together to avoid pregnancy. You should begin using birth control 4 weeks before starting treatment with this medicine. Continue the birth control 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.

Men who are sexually active must protect their female partner from getting pregnant. Pomalidomide will appear in the semen so male patients must not donate sperm. 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 even if you have had a vasectomy. Use a condom for sex during treatment with this medicine, 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 while you are taking this medicine and for at least 4 weeks after your last dose.

Using this medicine may increase your risk for having blood clots (eg, deep vein thrombosis, pulmonary embolism, stroke, or heart attack). Your risk for these serious problems is even greater if you have high blood pressure or high cholesterol, or if you smoke cigarettes. Contact your doctor right away if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.

Do not receive pembrolizumab together with pomalidomide or similar medicines and dexamethasone.

Pomalidomide 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis or angioedema, which may be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions 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, cough, sore throat, trouble breathing or swallowing, swelling of your hands, face, mouth, or throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, 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 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.

Pomalidomide may increase your risk of having new cancers (eg, acute myelogenous leukemia). Talk with your doctor about this risk.

This medicine may make you dizzy or confused. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).

Avoid cigarette smoking while using this medicine. The blood level may be lower than normal if you smoke.

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 or vitamin supplements.

Serious side effects of pomalidomide

Along with its needed effects, pomalidomide 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 pomalidomide:

Other side effects of pomalidomide

Some side effects of pomalidomide 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:

For healthcare professionals

Applies to pomalidomide: oral capsule.

Cardiovascular adverse events

• Common (1% to 10%): Deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, cardiac failure
• Frequency not reported: Atrial fibrillation, angina pectoris, congestive cardiac failure, hypotension^[Ref]

Hematologic

• Very common (10% or more): Neutropenia (53%), anemia (46%), thrombocytopenia (27%), leukopenia (20%), lymphopenia (15%)
• Common (1% to 10%): Febrile neutropenia, neutropenic sepsis, decreased neutrophil count, decreased white blood cell count, decreased platelet count, pancytopenia
• Frequency not reported: Decreased lymphocyte count, septic shock, decreased hemoglobin^[Ref]

Hepatic

• Common (1% to 10%): Increased ALT
• Uncommon (0.1% to 1%): Hepatitis, hyperbilirubinemia
• Frequency not reported: Increased AST
• Postmarketing reports: Hepatic failure^[Ref]

Hypersensitivity

• Postmarketing reports: Allergic reactions (e.g., angioedema, urticaria)^[Ref]

Nervous system

• Very common (10% or more): Dizziness (22%), peripheral neuropathy (22%), neuropathy (18%), headache (15%), tremor (13%), confusional state (13%)
• Common (1% to 10%): Depressed level of consciousness, vertigo
• Frequency not reported: Syncope
• Postmarketing reports: Tumor lysis syndrome^[Ref]

Oncologic

• Frequency not reported: Second primary malignancies (e.g., acute myelogenous leukemia)
• Postmarketing reports: Tumor lysis syndrome^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (45%), upper respiratory tract infection (37%), pneumonia (34%), cough (22%), epistaxis (17%), productive cough (13%), oropharyngeal pain (11%)
• Common (1% to 10%): Interstitial lung disease, bronchopneumonia, bronchitis, nasopharyngitis, epistaxis
• Frequency not reported: Pneumonitis, chronic obstructive pulmonary disease, pneumocystis jiroveci pneumonia, respiratory syncytial viral, pneumonia streptococcal, lobar pneumonia, lung infection, respiratory failure, bronchospasm^[Ref]

Dermatologic

• Very common (10% or more): Rash (21%), hyperhidrosis (16%), pruritus (15%), night sweats (13%), dry skin (11%)
• Frequency not reported: Cellulitis^[Ref]

Gastrointestinal

• Very common (10% or more): Constipation (37%), nausea (36%), diarrhea (36%), vomiting (14%)
• Very rare (less than 0.01%): Clostridium difficile colitis
• Frequency not reported: Abdominal pain^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (17%)
• Common (1% to 10%): Urinary retention, pelvic pain
• Frequency not reported: Urosepsis^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (23%), hypercalcemia (22%), hyperglycemia (15%), decreased weight (15%), hyponatremia (13%), hypokalemia (12%), hypocalcemia (12%), increased weight (11%)
• Common (1% to 10%): Dehydration, hyperkalemia
• Frequency not reported: Failure to thrive^[Ref]

Musculoskeletal

• Very common (10% or more): Back pain (35%), musculoskeletal chest pain (23%), muscle spasms (22%), bone pain (18%), arthralgia (17%), muscular weakness (14%), musculoskeletal pain (12%)
• Common (1% to 10%): Extremity pain
• Frequency not reported: Femur fracture, fall, compression fracture, spinal compression fracture^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (16%), anxiety (13%)
• Frequency not reported: Mental status change^[Ref]

Renal

• Very common (10% or more): Increased blood creatinine (19%), renal failure (15%)^[Ref]

Other

• Very common (10% or more): Fatigue and asthenia (63%), pyrexia (32%), peripheral edema (25%), chills (13%)
• Frequency not reported: Pain, general physical health deterioration, non-cardiac chest pain, multi-organ failure, viral infection^[Ref]

Immunologic

• Very common (10% or more): Infection (55%)
• Common (1% to 10%): Sepsis^[Ref]

See also:

Further information

Pomalidomide 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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