Dacogen Side Effects

Generic Name: decitabine

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

Side Effects of Dacogen - for the Consumer

Dacogen

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dacogen:

Constipation; cough; diarrhea; dizziness; hair loss; headache; joint or muscle pain; loss of appetite; nausea; stomach pain or upset; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine you produce; chest pain; confusion; depression; difficulty swallowing; fainting; fast or irregular heartbeat; fever, chills, or sore throat; numbness of an arm or leg; one-sided weakness; pain, swelling, or redness at the injection site; severe headache or dizziness; severe stomach pain or vomiting; shortness of breath; sores or white patches in the mouth; swelling; unusual bruising or bleeding; unusual tiredness or weakness; vision or speech changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Hematologic

Hematologic side effects including neutropenia (up to 90%), thrombocytopenia (up to 89%), anemia (up to 82%), febrile neutropenia (up to 29%), leukopenia (up to 28%), lymphadenopathy (12%), pancytopenia (5%), and thrombocythemia (5%) have been reported.

General

General side effects including pyrexia (53%), fatigue (46%), pyrexia (36%), peripheral edema (up to 27%), rigors (22%), edema (up to 18%), chills (16%), asthenia (15%), pain (13%), lethargy (12%), tenderness (11%), mucosal inflammation (9%), fall (8%), chest discomfort (7%), intermittent pyrexia (6%), chest pain (6%), malaise (5%), pain (5%), and crepitations (5%) have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 42%), constipation (up to 35%), diarrhea (up to 34%), vomiting (up to 25%), abdominal pain (14%), oral mucosal petechiae (13%), stomatitis (up to 12%), dyspepsia (up to 12%), ascites (10%), gingival bleeding (8%), hemorrhoids (8%), loose stools (7%), tongue ulceration (7%), dysphagia (up to 6%), oral soft tissue disorder (6%), toothache (6%), abdominal pain upper (up to 6%), lip ulceration (5%), abdominal distension (5%), gastroesophageal reflux disease (5%), oral pain (5%), and glossodynia (5%) have been reported.

Respiratory

Respiratory side effects including cough (up to 40%), dyspnea (29%), pharyngitis (16%), lung crackles (14%), epistaxis (13%), decreased breath sounds (10%), hypoxia (10%), pharyngolaryngeal pain (8%), rales (8%), pleural effusion (5%), sinus congestion (5%), and postnasal drip (5%) have been reported.

Other

Other side effects have included vascular disorders such as petechiae (39%), pallor (23%), and hematoma (5%). Other side effects such as laboratory abnormalities including increased blood alkaline phosphatase (11%), increased aspartate aminotransferase (10%), increased blood urea (10%), decreased weight (9% ), contusions (9%), increased blood lactate dehydrogenase (8%), decreased blood albumin (7%), increased blood bilirubin (6% ), increased blood bicarbonate (6%), decreased blood chloride (6%), ear pain (6%), abnormal breath sounds (5% ), decreased protein total (5%), decreased blood bicarbonate (5%), and decreased blood bilirubin (5%) have also been reported.

Metabolic

Metabolic side effects including hyperglycemia (up to 33%), hypoalbuminemia (24%), hypomagnesemia (up to 24%), anorexia (up to 23%), hypokalemia (up to 22%), hyponatremia (19%), decreased appetite (up to 16%), hyperkalemia (13%), and dehydration (up to 8%) have been reported.

Nervous system

Nervous system side effects including headache (up to 28%), dizziness (up to 21%), and hypoesthesia (11%) have been reported.

Psychiatric

Psychiatric side effects including insomnia (up to 28%), confusional state (up to 12%), anxiety (up to 11%) and depression (9%) have been reported.

Immunologic

Immunologic side effects have included infections and infestations such as pneumonia (22%), cellulitis (12%), candidal infection (10%), catheter related infection (8%), urinary tract infection (7%), staphylococcal infection (7%), oral candidiasis (6%), sinusitis (5%), and bacteremia (5%).

Dermatologic

Dermatologic side effects including ecchymosis (up to 22%), rash (19%), erythema (up to 14%), petechiae (12%), skin lesion (11%), pruritus (11%), rash (11%), alopecia (8%), dry skin (8%), urticaria (6%), facial swelling (6%), night sweats (5%), and cases of Sweet's syndrome (acute febrile neutrophilic dermatosis) have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (up to 20%), limb pain (19%), back pain (up to 18%), pain in extremity (18%), myalgia (up to 9%), chest wall pain (7%), muscle spasms (7%), musculoskeletal discomfort (6%), bone pain (6%), muscular weakness (5%), and musculoskeletal pain (5%) have been reported.

Cardiovascular

Cardiovascular side effects including cardiac murmur (16%), hypotension (up to 11%), tachycardia (8%), hypertension (6%), pulmonary edema (6%) and congestive cardiac failure (5%) have been reported.

Hepatic

Hepatic side effects including hyperbilirubinemia (14%) have been reported.

Hypersensitivity

Hypersensitivity side effects including transfusion reactions (7%) have been reported.

Ocular

Ocular side effects including blurred vision (6%) have been reported.

Genitourinary

Genitourinary side effects including dysuria (6%) and urinary frequency (5%) have been reported.

Local

Local side effects including catheter site erythema (5%), catheter site pain (5%), and injection site swelling (5%) have been reported.

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