What the label lists and what reports show
Decitabine side effects
Decitabine's FDA label: “Most common adverse reactions (> 50%) are neutropenia, thrombocytopenia, anemia, and pyrexia.” FAERS holds 4,243 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (455 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the decitabine FDA label on DailyMed (effective August 6, 2026, Sagent Pharmaceuticals); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (> 50%) are neutropenia, thrombocytopenia, anemia, and pyrexia.
Table 1: Adverse Reactions Reported in ≥ 5% of Patients in the Decitabine for Injection Group and at a Rate Greater than Supportive Care in the Controlled Trial in MDS
| Reaction | Decitabine for Injection N = 83 (%) | Supportive Care N = 81 (%) |
|---|---|---|
| Neutropenia | 75 (90) | 58 (72) |
| Thrombocytopenia | 74 (89) | 64 (79) |
| Anemia NOS | 68 (82) | 60 (74) |
| Febrile neutropenia | 24 (29) | 5 (6) |
| Leukopenia NOS | 23 (28) | 11 (14) |
| Lymphadenopathy | 10 (12) | 6 (7) |
| Thrombocythemia | 4 (5) | 1 (1) |
| Pulmonary edema NOS | 5 (6) | 0 (0) |
| Vision blurred | 5 (6) | 0 (0) |
| Nausea | 35 (42) | 13 (16) |
| Constipation | 29 (35) | 11 (14) |
| Diarrhea NOS | 28 (34) | 13 (16) |
| Vomiting NOS | 21 (25) | 7 (9) |
| Abdominal pain NOS | 12 (14) | 5 (6) |
| Oral mucosal petechiae | 11 (13) | 4 (5) |
| Stomatitis | 10 (12) | 5 (6) |
| Dyspepsia | 10 (12) | 1 (1) |
| Ascites | 8 (10) | 2 (2) |
| Gingival bleeding | 7 (8) | 5 (6) |
| Hemorrhoids | 7 (8) | 3 (4) |
| Loose stools | 6 (7) | 3 (4) |
| Tongue ulceration | 6 (7) | 2 (2) |
| Dysphagia | 5 (6) | 2 (2) |
| Oral soft tissue disorder NOS | 5 (6) | 1 (1) |
| Lip ulceration | 4 (5) | 3 (4) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (> 50%) are neutropenia, thrombocytopenia, anemia, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Decitabine for Injection was studied in 3 single-arm studies (N = 66, N = 98, N = 99) and 1 controlled supportive care study (N = 83 Decitabine for Injection, N = 81 supportive care). The data described below reflect exposure to Decitabine for Injection in 83 patients in the MDS trial. In the trial, patients received 15 mg/m 2 intravenously every 8 hours for 3 days every 6 weeks. The median number of Decitabine for Injection cycles was 3 (range 0 to 9). Most Common Adverse Reactions: neutropenia, thrombocytopenia, anemia, fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.
Source: FDA drug label, Sagent Pharmaceuticals, effective August 6, 2026 (SPL set 749f8d8c-e378-42a1-b94a-136b606dadb4), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,243 reports list decitabine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,154 are coded as a death and 1,533 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Decitabine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions