What the label lists and what reports show
Cedazuridine and decitabine side effects
Cedazuridine and decitabine's FDA label: “In MDS or CMML, the most common adverse reactions (incidence ≥ 20%) are fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper …” FAERS holds 875 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 fatigue (119 reports).
- No generic listed
Check it at the source: the cedazuridine and decitabine FDA label on DailyMed (effective May 25, 2026, Taiho Pharmaceutical Co., Ltd.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of INQOVI?INQOVI may cause serious side effects, including: Low blood cell counts. Low blood counts (white blood cells, platelets, and red blood cells) are common with INQOVI but can also be serious and lead to infections that may be life-threatening. If your blood cell counts are too low, your healthcare provider may need to delay treatment with INQOVI, lower your dose of INQOVI, or in some cases give you a medicine to help treat low blood cell counts. Your healthcare provider may need to give you antibiotic medicines to prevent or treat infections or fever while your blood cell counts are low. Your healthcare provider will check your blood cell counts before you start treatment and regularly during treatment with INQOVI. […]
Source: FDA drug label, Taiho Pharmaceutical Co., Ltd., effective May 25, 2026 (SPL set 91a0f80b-f865-4d06-a40d-4d148d99ee71), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn MDS or CMML, the most common adverse reactions (incidence ≥ 20%) are fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased.
Table 3: Adverse Reactions (≥10%) in Patients Who Received INQOVI in Pooled Safety Population
| Reaction | All Grades (%) | Grades 3 or 4 (%) | All Grades (%) | Grades 3 or 4 (%) | All Grades (%) | Grades 3 or 4 (%) |
|---|---|---|---|---|---|---|
| Fatigue Includes fatigue, asthenia, and lethargy | 29 | 2 | 25 | 0 | 55 | 5 |
| Hemorrhage Includes contusion, epistaxis, petechiae, hematuria, conjunctival hemorrhage,… | 24 | 2 | 17 | 0 | 43 | 3 |
| Edema Includes edema peripheral, peripheral swelling, swelling face, fluid overload,… | 10 | 0 | 11 | 0 | 30 | 0.5 |
| Pyrexia | 7 | 0 | 7 | 0 | 19 | 1 |
| Constipation Includes constipation and feces hard | 20 | 0 | 23 | 0 | 44 | 0 |
| Mucositis Includes oropharyngeal pain, stomatitis, mouth ulceration, proctalgia, oral… | 18 | 1 | 24 | 2 | 41 | 4 |
| Nausea | 25 | 0 | 16 | 0 | 40 | 0.5 |
| Diarrhea Includes diarrhea and feces soft | 16 | 0 | 11 | 0 | 37 | 1 |
| Transaminase increased Includes alanine aminotransferase increased, aspartate… | 12 | 1 | 3 | 0 | 21 | 3 |
| Abdominal pain Includes abdominal pain, abdominal pain upper, abdominal pain lower,… | 9 | 0 | 7 | 0 | 19 | 1 |
| Vomiting | 5 | 0 | 5 | 0 | 15 | 0 |
| Myalgia Includes myalgia, pain in extremity, muscle spasms, pain, musculoskeletal pain,… | 9 | 2 | 16 | 1 | 42 | 3 |
| Arthralgia Includes arthralgia, back pain, neck pain, joint stiffness, pain in jaw, joint… | 9 | 1 | 13 | 1 | 40 | 3 |
| Dyspnea Includes dyspnea, dyspnea exertional, hypoxia, wheezing, chronic obstructive… | 17 | 3 | 9 | 3 | 38 | 6 |
| Cough Includes cough and productive cough | 7 | 0 | 8 | 0 | 28 | 0 |
| Febrile neutropenia | 10 | 10 | 13 | 13 | 33 | 32 |
| Rash Includes maculo-papular rash, rash, erythema, skin lesion, folliculitis, dermatitis,… | 12 | 1 | 11 | 1 | 33 | 0.5 |
| Dizziness Includes dizziness, vertigo, postural dizziness, and positional vertigo | 16 | 1 | 11 | 0 | 33 | 2 |
| Headache Includes headache, sinus pain, and sinus headache | 22 | 0 | 13 | 0 | 30 | 0 |
| Neuropathy Includes hypoesthesia, paresthesia, neuropathy peripheral, gait disturbance,… | 4 | 0 | 8 | 0 | 13 | 0 |
| Decreased appetite | 10 | 1 | 6 | 0 | 24 | 2 |
| Upper respiratory tract infection Includes upper respiratory tract infection,… | 6 | 0 | 3 | 0 | 23 | 1 |
| Pneumonia Includes pneumonia, pneumonitis, atypical pneumonia, and lung infection | 7 | 7 | 7 | 5 | 21 | 15 |
| Sepsis Includes sepsis, bacteremia, septic shock, endocarditis, pseudomonal bacteremia,… | 6 | 6 | 2 | 1 | 14 | 11 |
| Cellulitis Includes cellulitis, catheter site cellulitis, and infected bite | 4 | 1 | 3 | 2 | 12 | 5 |
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) ] In MDS or CMML, the most common adverse reactions (incidence ≥ 20%) are fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased. The most common Grade 3 or 4 laboratory abnormalities (≥ 50%) were leukocytes decreased, platelet count decreased, neutrophil count decreased, and hemoglobin decreased. ( 6.1 ) In AML in combination with venetoclax, the most common adverse reactions (incidence ≥ 20%) are neutropenia, febrile neutropenia, thrombocytopenia, hemorrhage, anemia, infection (bacterial/viral), diarrhea, fatigue, mucositis, constipation, arthralgia, dyspnea, decreased appetite, edema, nausea, white blood cell count decreased, sepsis, pneumonia, rash, transaminitis, myalgia, arrhythmia, and abdominal pain. The most common Grade 3 or 4 laboratory abnormalities (≥ 50%) were leukocytes decreased, lymphocytes decreased, platelets decreased, and hemoglobin decreased.
Source: FDA drug label, Taiho Pharmaceutical Co., Ltd., effective May 25, 2026 (SPL set 91a0f80b-f865-4d06-a40d-4d148d99ee71), via openFDA; the full label on DailyMed
What do FAERS reports show?
875 reports list cedazuridine and decitabine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 176 are coded as a death and 340 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, 17 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?
- Cedazuridine and 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