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

Summary

Common side effects of Dacogen include: neutropenia and thrombocytopenia. Continue reading for a comprehensive list of adverse effects.

Applies to decitabine: intravenous powder for solution.

Serious side effects of Dacogen

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

Less common

• Collection of blood under the skin
• deep, dark purple bruise
• diarrhea
• pain or tenderness around the eyes and cheekbones
• pain, warmth, or burning in the fingers, toes, and legs
• problems with vision or hearing
• skin scrape or burn
• stuffy nose
• swelling at the injection site

Incidence not known

• Fever sores on the skin

Other side effects of Dacogen

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

• Anxiety
• back pain
• belching
• bumps on the skin
• chest discomfort
• constipation
• falls
• hair loss or thinning of the hair
• heartburn
• indigestion
• loose stools
• muscle stiffness
• pain in the arms or legs
• pain in joints
• stomach discomfort or upset
• swelling or inflammation of the mouth
• trouble sleeping
• unusual drowsiness, dullness, or feeling of sluggishness

Less common

• Difficulty in moving
• general feeling of discomfort or illness
• 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]