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Dacogen Side Effects

Generic Name: decitabine

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

For the Consumer

Applies to decitabine: intravenous powder for solution

Along with its needed effects, decitabine (the active ingredient contained in Dacogen) 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 or nurse immediately if any of the following side effects occur while taking decitabine:

More common
  • Black, tarry stools
  • bladder pain
  • bleeding after defecation
  • bleeding gums
  • blood in urine or stools
  • bloody or cloudy urine
  • blue lips and fingernails
  • blurred vision
  • body aches or pain
  • chest pain
  • chills
  • coma
  • congestion
  • convulsions
  • cough
  • coughing that sometimes produces a pink frothy sputum
  • decreased urination
  • difficult, burning, or painful urination
  • difficult, fast, noisy breathing, sometimes with wheezing
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • drowsiness
  • dry mouth
  • dryness of throat
  • facial swelling
  • fainting
  • fast or irregular heartbeat
  • feeling unusually cold
  • fever
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • headache
  • hives or welts
  • hoarseness
  • increased hunger
  • increased sweating
  • increased thirst
  • increased urination
  • itching, pain, redness, swelling, tenderness, or warmth on skin
  • lightheadedness
  • loss of appetite
  • lower back or side pain
  • mood or mental changes
  • muscle pain or cramps
  • muscle spasms or twitching
  • nausea or vomiting
  • nervousness
  • numbness or tingling in hands, feet, or lips
  • pale skin
  • pinpoint red spots on skin
  • redness or pain at the catheter site
  • runny nose
  • seizures
  • shivering
  • shortness of breath
  • skin rash
  • small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
  • small red or purple spots on skin, lips or in mouth
  • sneezing
  • sore mouth or tongue
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • stomach pain and bloating
  • sunken eyes
  • swelling of face, hands, ankles, feet, or lower legs
  • swollen, painful, or tender lymph glands in neck, armpit, or groin
  • tightness in chest
  • trembling
  • trouble in swallowing
  • troubled breathing with exertion
  • uncomfortable swelling around anus
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • voice changes
  • weakness or heaviness of legs
  • wheezing
  • white patches in mouth and/or on tongue
  • wrinkled skin
  • yellow eyes or skin
Less common
  • Collection of blood under skin
  • deep, dark purple bruise
  • diarrhea
  • pain or tenderness around eyes and cheekbones
  • pain, warmth, or burning in fingers, toes, and legs
  • problems with vision or hearing
  • skin scrape or burn
  • stuffy nose
  • swelling at injection site

Some side effects of decitabine 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
  • Acid or sour stomach
  • anxiety
  • back pain
  • belching
  • bumps on skin
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest discomfort
  • constipation
  • difficulty swallowing
  • fall
  • hair loss, thinning of hair
  • heartburn
  • indigestion
  • loose stools
  • muscle stiffness
  • pain in arms or legs
  • pain in joints
  • sleeplessness
  • stomach discomfort or upset
  • swelling or inflammation of the mouth
  • trouble sleeping
  • unable to sleep
  • unusual drowsiness, dullness, or feeling of sluggishness
Less common
  • Difficulty in moving
  • general feeling of discomfort or illness
  • muscle aching
  • pain in the tongue
  • postnasal drip
  • pressure in the stomach
  • swollen joints

For Healthcare Professionals

Applies to decitabine: intravenous powder for injection

Hematologic

Very common (10% or more): Neutropenia (90%), thrombocytopenia (89%), anemia (68%), febrile neutropenia (29%), leukopenia (28%), lymphadenopathy (12%)
Common (1% to 10%): Thrombocythemia
Uncommon (0.1% to 1%): Pancytopenia[Ref]

Gastrointestinal

Very common (10% or more): Nausea (42%), constipation (35%), diarrhea (34%), vomiting (25%), abdominal pain (14%), oral mucosal petechiae (13%), stomatitis (12%), dyspepsia (12%), ascites (10%)
Common (1% to 10%): Gingival bleeding, hemorrhoids, loose stools, tongue ulceration, dysphagia, oral soft tissue disorder, lip ulceration, abdominal distension, upper abdominal pain, gastroesophageal reflux disease, glossodynia
Frequency not reported: Enterocolitis (including neutropenic colitis, cecitis)[Ref]

Respiratory

Very common (10% or more): Cough (40%), pneumonia (24%), pharyngitis (16%), epistaxis (14%), lung crackles (14%), breath sounds decreased (10%), hypoxia (10%)
Common (1% to 10%): Sinusitis, rales, postnasal drip
Frequency not reported: Interstitial lung disease[Ref]

Other

Very common (10% or more): Pyrexia (53%), peripheral edema (25%), rigors (22%), edema (18%), pain (13%), lethargy (12%), tenderness (11%), blood alkaline phosphatase increased (11%), blood urea increased (10%)
Common (1% to 10%): Fall, chest wall pain, intermittent pyrexia, malaise, crepitations, blood lactate dehydrogenase increased, blood albumin decreased, blood bicarbonate increased, blood chloride decreased, decreased total protein, blood bilirubin decreased[Ref]

Metabolic

Very common (10% or more): Hyperglycemia (33%), hypoalbuminemia (24%), hypomagnesemia (24%), hypokalemia (22%), hyponatremia (19%), appetite decreased (16%), anorexia (16%), hyperkalemia (13%)
Common (1% to 10%): Dehydration[Ref]

Nervous system

Very common (10% or more): Headache (28%), dizziness (18%), hypoesthesia (11%)[Ref]

Psychiatric

Very common (10% or more): Insomnia (28%), confusion (12%), anxiety (11%)[Ref]

Immunologic

Very common (10% or more): Bacterial, viral, fungal infections (63%), candida infection (10%)
Common (1% to 10%): Septic shock, sepsis, staphylococcal infection, oral candidiasis, bacteremia[Ref]

Dermatologic

Very common (10% or more): Ecchymosis (22%), rash (19%), erythema (14%), cellulitis (12%) skin lesion (11%), pruritus (11%)
Common (1% to 10%): Alopecia, urticaria, swelling face
Uncommon (0.1% to 1%): Acute febrile neutrophilic dermatosis (Sweet's syndrome)[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (20%), pain in limb (19%), back pain (17%)
Common (1% to 10%): Chest wall pain, musculoskeletal discomfort, myalgia[Ref]

Cardiovascular

Very common (10% or more): Petechiae (39%), pallor (23%), cardiac murmur (16%)
Common (1% to 10%): Pulmonary edema, hypotension, hematoma[Ref]

Hepatic

Very common (10% or more): Hyperbilirubinemia (14%)[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity including anaphylaxis[Ref]

Ocular

Common (1% to 10%): Blurred vision[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (15%)
Common (1% to 10%): Dysuria, urinary frequency
.[Ref]

Local

Common (1% to 10%): Injection site erythema, injection site pain, injection site swelling[Ref]

References

1. "Product Information. Decitabine (decitabine)." Accord Healthcare Inc, Durham, NC.

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

Some side effects of Dacogen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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