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Pomalidomide Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 12, 2023.

Applies to pomalidomide: oral capsule.

Warning

Oral route (Capsule)

Pomalidomide is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue, and thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females who can become pregnant, obtain 2 negative pregnancy test before treatment initiation. It is required that females of reproductive potential use 2 forms of contraception or abstain from heterosexual sex during and for 4 weeks after stopping treatment with pomalidomide. The only way to acquire pomalidomide is through a restricted distribution program called POMALYST REMS. DVT, pulmonary embolism, myocardial infarction, and stroke have been reported in patients with multiple myeloma treated with pomalidomide. Thromboprophylaxis is recommended, and the regimen choice should be based on assessment of the underlying risk factors of the patient.

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:

More common

Less common

Incidence not known

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:

More common

Incidence not known

For Healthcare Professionals

Applies to pomalidomide: oral capsule.

Cardiovascular

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]

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Pomalyst (pomalidomide). QLT Phototherapeutics Inc. 2013.

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.

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