Summary
Commonly reported side effects of pomalidomide include: anemia, anxiety, confusion, dizziness, neuropathy, neutropenia, peripheral neuropathy, and thrombocytopenia. Other side effects include: acute myocardial infarction, cerebrovascular accident, and febrile neutropenia. Continue reading for a comprehensive list of adverse effects.
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
- 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
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
- 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%): 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]
