Drug · FAERS side-effect profile with label screen
Azacitidine For side effects: what 18,083 FDA adverse event reports show
Drug class
Nucleoside Metabolic Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Azacitidine
openFDA label
Who reports
18,083 reports · 97% serious · 5,996 with death outcome · 40% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if.
FDA label, Indications and Usage
What it is
Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 1Likely indication confounding 10Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 24
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 985 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Flt3 gene mutation | 12 | 4,573.3 1,290.6–16,205.0ROR 4,576.3 · χ² 10,075 / p <1e-300 | 371.7 EB05 226.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Allogenic stem cell transplantation | 50 | 549.7 392.4–769.9ROR 551.2 · χ² 18,124 / p <1e-300 | 325.2 EB05 256.4 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=49 | not reported in cached trials |
| Acute myeloid leukaemia refractory | 51 | 507.0 364.7–704.9ROR 508.5 · χ² 17,495 / p <1e-300 | 310.6 EB05 245.4 · IC025 +5.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=51 | not reported in cached trials |
| Protothecosis | 25 | 420.3 265.8–664.6ROR 420.9 · χ² 7,343 / p <1e-300 | 249.1 EB05 177.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 40%) · 100% clinician | not reported in cached trials |
| Emphysematous cholecystitis | 13 | 401.7 213.6–755.6ROR 402.0 · χ² 3,554 / p <1e-300 | 207.3 EB05 128.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Corynebacterium bacteraemia | 20 | 368.8 222.8–610.4ROR 369.2 · χ² 5,272 / p <1e-300 | 220.5 EB05 150.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Acute myeloid leukaemia recurrent | 454 | 314.8 284.0–348.9ROR 322.9 · χ² 111,111 / p <1e-300 | 244.5 EB05 226.2 · IC025 +7.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=453 · 91% clinician | not reported in cached trials |
| Parainfluenza virus infection | 12 | 298.3 158.0–562.9ROR 298.5 · χ² 2,589 / p <1e-300 | 172.4 EB05 105.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Cord blood transplant therapy | 17 | 285.8 168.0–486.2ROR 286.1 · χ² 3,635 / p <1e-300 | 182.3 EB05 120.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=17 | not reported in cached trials |
| Chimerism | 14 | 216.3 122.2–382.9ROR 216.5 · χ² 2,345 / p <1e-300 | 146.2 EB05 92.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Bacillus bacteraemia | 17 | 211.3 126.0–354.4ROR 211.5 · χ² 2,828 / p <1e-300 | 149.0 EB05 98.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Blastic plasmacytoid dendritic cell neoplasia | 10 | 168.1 86.6–326.5ROR 168.2 · χ² 1,306 / p 2e-286 | 115.1 EB05 66.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Leukostasis syndrome | 16 | 164.8 97.6–278.3ROR 164.9 · χ² 2,136 / p <1e-300 | 123.3 EB05 80.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Minimal residual disease | 51 | 141.5 105.8–189.3ROR 141.9 · χ² 6,208 / p <1e-300 | 120.5 EB05 95.2 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=51 · 94% clinician | not reported in cached trials |
| Transformation to acute myeloid leukaemia | 69 | 136.0 106.0–174.5ROR 136.5 · χ² 8,144 / p <1e-300 | 117.8 EB05 96.2 · IC025 +5.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=69 | not reported in cached trials |
| Differentiation syndrome | 67 | 119.9 93.2–154.1ROR 120.3 · χ² 7,042 / p <1e-300 | 105.4 EB05 85.9 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=67 · 99% clinician | NCT03416179: 2/160 (1.2%) control (serious AE) |
| Acute myeloid leukaemia | 1,299 | 105.6 99.9–111.5ROR 113.7 · χ² 123,173 / p <1e-300 | 96.6 EB05 92.3 · IC025 +6.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 57.5 · 93% clinician | not reported in cached trials |
| Congenital aplasia | 23 | 100.0 65.3–153.1ROR 100.1 · χ² 1,983 / p <1e-300 | 85.7 EB05 60.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 10% (drug 40%) · 100% clinician | not reported in cached trials |
| Geotrichum infection | 16 | 94.3 56.6–157.0ROR 94.4 · χ² 1,279 / p 2e-280 | 79.2 EB05 51.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Blast cell count increased | 76 | 90.4 71.6–114.2ROR 90.8 · χ² 6,146 / p <1e-300 | 82.2 EB05 67.8 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=75 | not reported in cached trials |
| Aeromonas infection | 12 | 85.2 47.4–153.2ROR 85.3 · χ² 853 / p 1e-187 | 70.8 EB05 43.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Pneumonia adenoviral | 13 | 84.4 48.1–148.3ROR 84.5 · χ² 922 / p 8e-203 | 70.9 EB05 44.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Red blood cell transfusion | 25 | 77.3 51.5–115.8ROR 77.4 · χ² 1,692 / p <1e-300 | 68.8 EB05 49.0 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=25 | not reported in cached trials |
| Adenoviral hepatitis | 14 | 74.4 43.4–127.8ROR 74.5 · χ² 885 / p 1e-194 | 64.1 EB05 40.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Chronic myelomonocytic leukaemia | 36 | 66.3 47.4–92.7ROR 66.4 · χ² 2,127 / p <1e-300 | 60.8 EB05 45.9 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications | serious n=36 · ♀ 13% (drug 40%) | not reported in cached trials |
| Bacillus infection | 33 | 64.6 45.5–91.7ROR 64.7 · χ² 1,896 / p <1e-300 | 59.2 EB05 44.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=33 · 100% clinician | not reported in cached trials |
| Chloroma | 22 | 63.7 41.5–97.8ROR 63.8 · χ² 1,227 / p 4e-269 | 57.5 EB05 40.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=22 · 95% clinician | not reported in cached trials |
| Blood product transfusion dependent | 21 | 60.3 38.9–93.5ROR 60.4 · χ² 1,108 / p 3e-243 | 54.7 EB05 37.7 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 · 90% clinician | not reported in cached trials |
| Tissue infiltration | 14 | 58.2 34.0–99.6ROR 58.2 · χ² 696 / p 1e-153 | 51.8 EB05 32.8 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | not reported in cached trials |
| Graft versus host disease in lung | 21 | 53.6 34.6–83.0ROR 53.7 · χ² 986 / p 1e-216 | 49.1 EB05 33.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | not reported in cached trials |
| Myelosuppression | 1,502 | 53.5 51.0–56.3ROR 58.3 · χ² 74,052 / p <1e-300 | 51.2 EB05 49.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 30.4 · 98% clinician | not reported in cached trials |
| Refractory anaemia with an excess of blasts | 14 | 53.5 31.3–91.5ROR 53.6 · χ² 640 / p 2e-141 | 48.1 EB05 30.4 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications | serious n=14 | not reported in cached trials |
| Anorectal infection | 11 | 52.4 28.6–95.9ROR 52.4 · χ² 482 / p 3e-107 | 46.4 EB05 27.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | NCT03416179: 1/201 (0.5%) control (serious AE) |
| Platelet transfusion | 55 | 52.1 39.8–68.3ROR 52.3 · χ² 2,590 / p <1e-300 | 49.1 EB05 39.2 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=55 · ♀ 61% (drug 40%) | not reported in cached trials |
| Primary myelofibrosis | 13 | 49.5 28.4–86.3ROR 49.6 · χ² 547 / p 3e-121 | 44.6 EB05 27.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Pneumonia fungal | 157 | 48.9 41.7–57.3ROR 49.3 · χ² 7,016 / p <1e-300 | 46.7 EB05 40.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=157 · 91% clinician | NCT03416179: 2/162 (1.2%) on Azacitidine For; 2/201 (1.0%) control (serious AE) |
| Blast cells present | 19 | 47.8 30.2–75.7ROR 47.9 · χ² 792 / p 1e-174 | 44.1 EB05 29.8 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=19 | not reported in cached trials |
| Granulocyte count decreased | 67 | 45.3 35.5–57.8ROR 45.4 · χ² 2,748 / p <1e-300 | 43.1 EB05 35.1 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=67 · 99% clinician | not reported in cached trials |
| Cytopenia | 449 | 45.2 41.2–49.7ROR 46.4 · χ² 18,657 / p <1e-300 | 43.5 EB05 40.2 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 26.2 · 91% clinician | NCT03416179: 1/160 (0.6%) on Azacitidine For; 3/201 (1.5%) control (serious AE) |
| Periorbital cellulitis | 20 | 45.0 28.8–70.4ROR 45.1 · χ² 786 / p 3e-173 | 41.8 EB05 28.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Azacitidine For as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).
- NCT03416179 — A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib I (N=730, PHASE3; 334 AE terms posted; arms: Intensive Study: Glasdegib + Cytarabine ; Intensive Study: Placebo + Cytarabine + ; Non-intensive Study: Glasdegib + Azaciti; Non-intensive Study: Placebo + Azacitidi)
- NCT04313881 — Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (N=539, PHASE3; 339 AE terms posted; arms: Magrolimab + Azacitidine; Placebo + Azacitidine)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 1,995 | 36.0 34.5–37.5ROR 40.3 · χ² 65,990 / p <1e-300 | 34.9 EB05 33.7 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.8 · 95% clinician | NCT03416179: 20/160 (12.5%) on Azacitidine For; 17/201 (8.5%) control (serious AE) |
| Death | 1,847 | 2.5 2.4–2.6ROR 2.7 · χ² 1,712 / p <1e-300 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 1.5 | NCT03416179: 4/162 (2.5%) on Azacitidine For; 2/160 (1.2%) control (serious AE) |
| Off label use (used outside approved label) | 1,528 | 2.0 1.9–2.1ROR 2.1 · χ² 847 / p 2e-186 | 2.0 EB05 2.0 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.1 | not reported in cached trials |
| Myelosuppression | 1,502 | 53.5 51.0–56.3ROR 58.3 · χ² 74,052 / p <1e-300 | 51.2 EB05 49.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 30.4 · 98% clinician | not reported in cached trials |
| Neutropenia (low neutrophils (infection-fighting cells)) | 1,359 | 11.7 11.2–12.4ROR 12.6 · χ² 13,293 / p <1e-300 | 11.6 EB05 11.1 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.1 · 95% clinician | NCT03416179: 20/160 (12.5%) on Azacitidine For; 17/201 (8.5%) control (serious AE) |
| Acute myeloid leukaemia | 1,299 | 105.6 99.9–111.5ROR 113.7 · χ² 123,173 / p <1e-300 | 96.6 EB05 92.3 · IC025 +6.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 57.5 · 93% clinician | not reported in cached trials |
| Pneumonia (lung infection) | 1,058 | 3.8 3.6–4.0ROR 4.0 · χ² 2,212 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 · 93% clinician | NCT03416179: 36/160 (22.5%) on Azacitidine For; 11/201 (5.5%) control (serious AE) |
| Drug ineffective (drug did not work) | 1,006 | 0.9 0.8–0.9ROR 0.9 · χ² 16 / p 4e-5 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.5 · 93% clinician | not reported in cached trials |
| Pyrexia (fever) | 998 | 3.3 3.2–3.6ROR 3.5 · χ² 1,665 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | NCT03416179: 11/160 (6.9%) on Azacitidine For; 6/201 (3.0%) control (serious AE) |
| Thrombocytopenia (low platelets) | 981 | 10.3 9.7–10.9ROR 10.8 · χ² 8,183 / p <1e-300 | 10.2 EB05 9.7 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.2 · 96% clinician | NCT03416179: 1/160 (0.6%) on Azacitidine For; 3/201 (1.5%) control (serious AE) |
| Anaemia (low red blood cells) | 792 | 4.8 4.5–5.2ROR 5.0 · χ² 2,412 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.1 · 95% clinician | NCT03416179: 5/160 (3.1%) on Azacitidine For; 1/201 (0.5%) control (serious AE) |
| Infection | 684 | 5.5 5.1–5.9ROR 5.7 · χ² 2,534 / p <1e-300 | 5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 91% clinician | NCT03416179: 1/162 (0.6%) on Azacitidine For; 5/160 (3.1%) control (serious AE) |
| Sepsis (blood infection) | 660 | 6.9 6.4–7.4ROR 7.1 · χ² 3,317 / p <1e-300 | 6.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 93% clinician | NCT03416179: 5/160 (3.1%) on Azacitidine For; 2/201 (1.0%) control (serious AE) |
| Pancytopenia (all blood cells low) | 636 | 13.4 12.4–14.4ROR 13.8 · χ² 7,206 / p <1e-300 | 13.2 EB05 12.4 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · 93% clinician | not reported in cached trials |
| Platelet count decreased | 600 | 6.6 6.1–7.1ROR 6.8 · χ² 2,822 / p <1e-300 | 6.5 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | NCT03416179: 1/162 (0.6%) on Azacitidine For (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Allogenic stem cell transplantation — n=50, PRR 549.7
- Protothecosis — n=25, PRR 420.3
- Corynebacterium bacteraemia — n=20, PRR 368.8
- Minimal residual disease — n=51, PRR 141.5
- Congenital aplasia — n=23, PRR 100.0
- Bacillus infection — n=33, PRR 64.6
- Chloroma — n=22, PRR 63.7
- Graft versus host disease in lung — n=21, PRR 53.6
- Myelosuppression — n=1,502, PRR 53.5
- Pneumonia fungal — n=157, PRR 48.9 (also seen in trial arm)
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Azacitidine For?
In FDA FAERS, the most frequently co-reported reaction terms for Azacitidine For are febrile neutropenia, myelosuppression, neutropenia, acute myeloid leukaemia, pneumonia, pyrexia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Azacitidine For have an FDA boxed warning?
No. The FDA label retrieved for Azacitidine For has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Azacitidine For causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0095c67b-42f3-47e6-92db-f77843727bca, effective 20241216; matched on
openfda.generic_name.exact:"AZACITIDINE FOR") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,025 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
AZACITIDINE FOR, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.