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Pomalyst Side Effects

Generic Name: pomalidomide

Note: This document contains side effect information about pomalidomide. Some of the dosage forms listed on this page may not apply to the brand name Pomalyst.

For the Consumer

Applies to pomalidomide: oral capsule

Along with its needed effects, pomalidomide (the active ingredient contained in Pomalyst) 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

  • Black, tarry stools
  • bladder pain
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine or stools
  • bloody nose
  • body aches or pain
  • burning, numbness, tingling, or painful sensations
  • chest pain
  • chills
  • cloudy urine
  • confusion
  • constipation
  • cough
  • decreased or increased urination
  • difficult, burning, or painful urination
  • difficulty with breathing
  • discouragement
  • dizziness
  • dry mouth
  • ear congestion
  • fast or irregular heartbeat
  • feeling sad or empty
  • fever
  • frequent urge to urinate
  • headache
  • incoherent speech
  • increased thirst
  • irritability
  • lack of appetite
  • loss of appetite
  • loss of interest or pleasure
  • loss of voice
  • lower back or side pain
  • metallic taste
  • muscle pain or cramps
  • muscle weakness
  • nasal congestion
  • nausea
  • numbness or tingling in the hands, feet, or lips
  • pain
  • pale skin
  • pinpoint red spots on the skin
  • rapid weight gain
  • runny nose
  • shakiness in the legs, arms, hands, or feet
  • sneezing
  • sore throat
  • stomach pain
  • tightness in the chest
  • trembling or shaking of the hands or feet
  • trouble concentrating
  • trouble sleeping
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • vomiting
  • weakness in the arms, hands, legs, or feet

Less Common

  • Anxiety
  • dizziness or lightheadedness
  • fainting
  • pain, redness, or swelling in the arm or leg
  • troubled breathing

Incidence Not Known

  • Blistering, peeling, or loosening of the skin
  • diarrhea
  • difficulty in passing urine (dribbling)
  • itching
  • joint pain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • unusual tiredness or weakness
  • weakness or heaviness of the legs
  • yellow eyes or skin

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

  • Back pain
  • blurred vision
  • decreased appetite
  • difficulty with moving
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased sweating
  • lack or loss of strength
  • muscle spasms or stiffness
  • night sweats
  • rash

Incidence Not Known

  • Feeling of constant movement of self or surroundings
  • sensation of spinning

For Healthcare Professionals

Applies to pomalidomide: oral capsule

Cardiovascular

Common (1% to 10%): Thromboembolic events (venous: deep vein thrombosis, pulmonary embolism; and arterial: myocardial infarction, stroke), cardiac failure

Frequency not reported: Atrial fibrillation, angina pectoris, congestive cardiac failure, hypotension[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 53.3%), anemia (up to 45.7%), thrombocytopenia (up to 27%), leukopenia (up to 19.6%), lymphopenia (up to 15.2%)

Common (1% to 10%): Febrile neutropenia, neutropenic sepsis, 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 (up to 22.4%), peripheral neuropathy (up to 21.5%), neuropathy (up to 18%), headache (up to 15%), tremor (up to 13.4%), confusional state (up to 13.4%)

Common (1% to 10%): Depressed level of consciousness, vertigo

Frequency not reported: Syncope[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 (up to 44.6%), upper respiratory tract infection (up to 37.4%), pneumonia (33.9%), cough (up to 22.3%), epistaxis (up to 16.8%), productive cough (up to 12.5%), oropharyngeal pain (up to 10.7%)

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 (up to 20.6%), hyperhidrosis (up to 16.1%), pruritus (up to 15%), night sweats (up to 12.5%), dry skin (up to 10.7%)

Frequency not reported: Cellulitis[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 36.6%), nausea (up to 36.4%), diarrhea (up to 35.7%), vomiting (up to 14.3%)

Very rare (less than 0.01%): Clostridium difficile colitis

Frequency not reported: Abdominal pain[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 17%)

Common (1% to 10%): Urinary retention, pelvic pain

Frequency not reported: Urosepsis[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 23.4%), hypercalcemia (up to 21.5%), hyperglycemia (up to 15.2%), decreased weight (up to 15%), hyponatremia (up to 12.5%), hypokalemia (up to 12.1%), hypocalcemia (up to 11.6%), increased weight (up to 10.7%)

Common (1% to 10%): Dehydration, hyperkalemia

Frequency not reported: Failure to thrive[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 34.6%), musculoskeletal chest pain (23.4%), muscle spasms (21.5%), bone pain (up to 18%), arthralgia (up to 16.8%), muscular weakness (up to 14%), musculoskeletal pain (up to 12.1%)

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 (up to 16.1%), anxiety (up to 13.1%)

Frequency not reported: Mental status change[Ref]

Renal

Very common (10% or more): Increased blood creatinine (up to 18.7%), renal failure (up to 15%)[Ref]

Other

Very common (10% or more): Fatigue and asthenia (up to 62.5%), infection (up to 55%), pyrexia (up to 32.1%), peripheral edema (up to 25.2%), chills (up to 12.5%)

Frequency not reported: Pain, general physical health deterioration, non-cardiac chest pain, multi-organ failure, viral infection[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Pomalyst (pomalidomide)." QLT Phototherapeutics Inc, Vancouver, AZ.

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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