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Pomalyst Side Effects

Generic Name: pomalidomide

Note: This page contains side effects data for the generic drug pomalidomide. It is possible that some of the dosage forms included below may not apply to the brand name Pomalyst.

It is possible that some side effects of Pomalyst may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to pomalidomide: oral capsule

As well as its needed effects, pomalidomide (the active ingredient contained in Pomalyst) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking pomalidomide, check with your doctor immediately:

More common
  • Abdominal or stomach pain
  • 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
  • depression
  • difficult, burning, or painful urination
  • difficulty with breathing
  • dizziness
  • dry mouth
  • ear congestion
  • fast or irregular heartbeat
  • fever
  • frequent urge to urinate
  • headache
  • incoherent speech
  • increased thirst
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • metallic taste
  • muscle pain or cramps
  • muscle weakness
  • nasal congestion
  • nausea or vomiting
  • 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
  • tightness in the chest
  • trembling or shaking of the hands or feet
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • weakness in the arms, hands, legs, or feet
Less common
  • Anxiety
  • dizziness or lightheadedness
  • fainting
  • pain, redness, or swelling in the arm or leg
  • sudden shortness of breath or troubled breathing
Incidence not known
  • Difficulty in passing urine (dribbling)
  • weakness or heaviness of the legs
  • yellow eyes or skin

Some pomalidomide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

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

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