Azathioprine side effects: what 87,582 FDA adverse event reports show
Who reports
87,582 reports · 87% serious · 8,696 with death outcome · 62% female
Used for
Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation.
What it is
Azathioprine is a thiopurine that is 6-mercaptopurine in which the mercapto hydrogen is replaced by a 1-methyl-4-nitroimidazol-5-yl group. It is a prodrug for mercaptopurine and is used as an immunosuppressant, prescribed for the treatment of inflammatory conditions and after organ transplantation and also for...
Boxed warning
- MALIGNANCY Chronic immunosuppression with azathioprine, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 1,270 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Synovial fluid analysis | 79 | 2,654.9 1,225.7–5,750.7ROR 2,657.3 · χ² 16,843 / p <1e-300 | 206.2 EB05 170.8 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=79 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Grip strength | 119 | 254.5 196.4–329.8ROR 254.8 · χ² 14,311 / p <1e-300 | 120.4 EB05 103.3 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=119 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Hepatosplenic t-cell lymphoma | 155 | 171.2 139.2–210.5ROR 171.5 · χ² 15,081 / p <1e-300 | 98.3 EB05 86.0 · IC025 +6.0 3/3 methods agree | Labeled — boxed warning exact term | serious n=155 · ♀ 31% (drug 62%) · 100% clinician | not reported in cached trials |
| Pulmonary vasculitis | 212 | 160.9 135.1–191.6ROR 161.3 · χ² 19,909 / p <1e-300 | 95.1 EB05 84.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=212 · ♀ 0% (drug 62%) | not reported in cached trials |
| Lupus vulgaris | 437 | 139.3 123.8–156.8ROR 140.0 · χ² 37,602 / p <1e-300 | 87.5 EB05 80.9 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=437 · ♀ 100% (drug 62%) · 95% clinician | not reported in cached trials |
| Blood iron abnormal | 359 | 138.4 121.5–157.7ROR 139.0 · χ² 30,753 / p <1e-300 | 87.1 EB05 79.8 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=357 · ♀ 100% (drug 62%) | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 235 | 130.4 111.2–152.9ROR 130.7 · χ² 19,330 / p <1e-300 | 83.7 EB05 75.1 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious n=235 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Total lung capacity abnormal | 129 | 122.9 99.3–152.0ROR 123.0 · χ² 10,163 / p <1e-300 | 80.1 EB05 69.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=128 · ♀ 0% (drug 62%) | not reported in cached trials |
| Retinitis | 491 | 99.8 89.8–110.9ROR 100.4 · χ² 33,660 / p <1e-300 | 70.2 EB05 65.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=491 · ♀ 100% (drug 62%) · 94% clinician | not reported in cached trials |
| Sle arthritis | 84 | 99.8 77.3–128.8ROR 99.9 · χ² 5,699 / p <1e-300 | 69.3 EB05 57.7 · IC025 +5.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=84 · ♀ 100% (drug 62%) · 100% clinician | NCT00094458: 1/163 (0.6%) control (serious AE) |
| Ileocaecal resection | 93 | 93.1 73.2–118.4ROR 93.2 · χ² 6,005 / p <1e-300 | 66.1 EB05 55.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=93 · 100% clinician | not reported in cached trials |
| Capillaritis | 73 | 89.4 68.3–117.1ROR 89.5 · χ² 4,561 / p <1e-300 | 64.0 EB05 52.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=73 · ♀ 0% (drug 62%) · 100% clinician | not reported in cached trials |
| Elbow deformity | 88 | 80.9 63.5–103.0ROR 80.9 · χ² 5,106 / p <1e-300 | 59.7 EB05 49.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=88 · ♀ 100% (drug 62%) | not reported in cached trials |
| Coombs positive haemolytic anaemia | 108 | 72.6 58.5–90.1ROR 72.7 · χ² 5,772 / p <1e-300 | 55.2 EB05 47.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=108 · ♀ 0% (drug 62%) · 100% clinician | not reported in cached trials |
| Bone erosion | 814 | 71.4 66.0–77.2ROR 72.0 · χ² 43,286 / p <1e-300 | 54.9 EB05 51.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=814 · ♀ 92% (drug 62%) | not reported in cached trials |
| Overlap syndrome | 152 | 67.6 56.4–80.9ROR 67.7 · χ² 7,695 / p <1e-300 | 52.4 EB05 45.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=152 · ♀ 100% (drug 62%) | not reported in cached trials |
| Seronegative arthritis | 247 | 67.5 58.6–77.7ROR 67.7 · χ² 12,521 / p <1e-300 | 52.5 EB05 47.2 · IC025 +5.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=247 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Cholestasis of pregnancy | 100 | 67.0 53.7–83.7ROR 67.1 · χ² 5,010 / p <1e-300 | 51.9 EB05 43.9 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=99 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Granuloma skin | 181 | 66.8 56.7–78.8ROR 67.0 · χ² 9,091 / p <1e-300 | 52.0 EB05 45.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=180 · ♀ 100% (drug 62%) | not reported in cached trials |
| Spirometry abnormal | 125 | 64.6 53.0–78.8ROR 64.7 · χ² 6,093 / p <1e-300 | 50.5 EB05 43.5 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=125 · ♀ 0% (drug 62%) | not reported in cached trials |
| Deep vein thrombosis postoperative | 413 | 63.8 57.2–71.1ROR 64.1 · χ² 20,034 / p <1e-300 | 50.3 EB05 46.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=413 · ♀ 100% (drug 62%) · 94% clinician | not reported in cached trials |
| Facet joint syndrome | 644 | 61.4 56.3–66.9ROR 61.8 · χ² 30,294 / p <1e-300 | 48.8 EB05 45.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=644 · ♀ 100% (drug 62%) · 96% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 404 | 59.9 53.7–66.8ROR 60.2 · χ² 18,610 / p <1e-300 | 47.9 EB05 44.1 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=404 · ♀ 100% (drug 62%) · 96% clinician | not reported in cached trials |
| Nodular regenerative hyperplasia | 142 | 59.7 49.6–71.7ROR 59.7 · χ² 6,486 / p <1e-300 | 47.5 EB05 41.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=142 · ♀ 0% (drug 62%) · 100% clinician | not reported in cached trials |
| Rheumatic fever | 871 | 59.5 55.3–64.1ROR 60.1 · χ² 39,971 / p <1e-300 | 47.7 EB05 45.1 · IC025 +5.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=871 · ♀ 100% (drug 62%) · 94% clinician | not reported in cached trials |
| Dislocation of vertebra | 421 | 55.8 50.2–62.0ROR 56.1 · χ² 18,270 / p <1e-300 | 45.2 EB05 41.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=421 · ♀ 100% (drug 62%) · 95% clinician | not reported in cached trials |
| Mite allergy | 120 | 55.4 45.4–67.5ROR 55.4 · χ² 5,141 / p <1e-300 | 44.7 EB05 38.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=120 · ♀ 0% (drug 62%) | not reported in cached trials |
| Antineutrophil cytoplasmic antibody positive | 128 | 50.9 42.1–61.7ROR 51.0 · χ² 5,111 / p <1e-300 | 41.8 EB05 36.1 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=128 · ♀ 0% (drug 62%) | not reported in cached trials |
| Clear cell renal cell carcinoma | 111 | 46.2 37.7–56.6ROR 46.3 · χ² 4,066 / p <1e-300 | 38.6 EB05 32.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=111 | not reported in cached trials |
| Eosinophilic granulomatosis with polyangiitis | 324 | 45.7 40.6–51.4ROR 45.8 · χ² 11,818 / p <1e-300 | 38.3 EB05 34.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=323 · ♀ 20% (drug 62%) | not reported in cached trials |
| X-ray abnormal | 282 | 44.8 39.5–50.9ROR 45.0 · χ² 10,113 / p <1e-300 | 37.7 EB05 34.2 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=282 · ♀ 100% (drug 62%) | not reported in cached trials |
| Tenosynovitis stenosans | 88 | 44.6 35.5–56.0ROR 44.7 · χ² 3,117 / p <1e-300 | 37.4 EB05 31.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=88 · ♀ 100% (drug 62%) · 100% clinician | not reported in cached trials |
| Terminal ileitis | 94 | 44.1 35.4–55.0ROR 44.2 · χ² 3,301 / p <1e-300 | 37.1 EB05 31.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=94 | not reported in cached trials |
| Ileal stenosis | 272 | 43.1 37.9–49.1ROR 43.3 · χ² 9,428 / p <1e-300 | 36.5 EB05 33.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=272 | NCT00094458: 1/17 (5.9%) on Azathioprine (serious AE) |
| Anti-cyclic citrullinated peptide antibody positive | 1,037 | 40.8 38.2–43.6ROR 41.3 · χ² 34,294 / p <1e-300 | 34.9 EB05 33.2 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious PRR 23.3 · ♀ 100% (drug 62%) · 94% clinician | not reported in cached trials |
| Swollen joint count increased | 448 | 40.1 36.2–44.3ROR 40.3 · χ² 14,547 / p <1e-300 | 34.3 EB05 31.7 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=448 · ♀ 100% (drug 62%) · 95% clinician | not reported in cached trials |
| Mycotic allergy | 121 | 40.0 33.0–48.5ROR 40.1 · χ² 3,902 / p <1e-300 | 34.2 EB05 29.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=121 · ♀ 0% (drug 62%) | not reported in cached trials |
| C-reactive protein abnormal | 911 | 39.6 36.9–42.5ROR 40.0 · χ² 29,308 / p <1e-300 | 34.0 EB05 32.2 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=910 · ♀ 93% (drug 62%) | NCT00094458: 1/18 (5.6%) control |
| Lung transplant rejection | 93 | 38.8 31.2–48.3ROR 38.8 · χ² 2,907 / p <1e-300 | 33.2 EB05 27.9 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=92 · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 790 | 37.9 35.2–40.8ROR 38.2 · χ² 24,412 / p <1e-300 | 32.7 EB05 30.9 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=790 · ♀ 100% (drug 62%) · 93% 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 Azathioprine 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 (3 of 40 signal terms matched).
- NCT00094458 — Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease n (N=508, PHASE3; 215 AE terms posted; arms: W30-Azathioprine + Placebo; W30-Infliximab + Placebo; W30-Infliximab + Azathioprine; W50-Azathioprine + Placebo)
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 13,304 | 3.7 3.7–3.8ROR 4.2 · χ² 27,071 / p <1e-300 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | not reported in cached trials |
| Drug ineffective (drug did not work) | 13,008 | 2.4 2.3–2.4ROR 2.6 · χ² 10,982 / p <1e-300 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | not reported in cached trials |
| Condition aggravated | 6,552 | 5.3 5.2–5.4ROR 5.6 · χ² 22,608 / p <1e-300 | 5.2 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | not reported in cached trials |
| Arthralgia (joint pain) | 5,866 | 3.4 3.3–3.5ROR 3.6 · χ² 10,120 / p <1e-300 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | NCT00094458: 1/163 (0.6%) control (serious AE) |
| Diarrhoea (diarrhea) | 5,484 | 2.1 2.0–2.1ROR 2.1 · χ² 3,016 / p <1e-300 | 2.0 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT00094458: 1/163 (0.6%) control (serious AE) |
| Nausea | 5,224 | 1.6 1.5–1.6ROR 1.6 · χ² 1,177 / p 3e-258 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 | NCT00094458: 1/17 (5.9%) on Azathioprine; 46/161 (28.6%) control |
| Fatigue (tiredness) | 5,137 | 1.6 1.5–1.6ROR 1.6 · χ² 1,150 / p 2e-252 | 1.6 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.7 | NCT00094458: 6/17 (35.3%) on Azathioprine; 22/161 (13.7%) control |
| Headache | 4,420 | 1.7 1.6–1.7ROR 1.7 · χ² 1,288 / p 2e-282 | 1.7 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.0 | NCT00094458: 1/17 (5.9%) on Azathioprine; 19/161 (11.8%) control |
| Pain | 4,228 | 1.6 1.6–1.7ROR 1.7 · χ² 1,106 / p 9e-243 | 1.6 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT00094458: 4/179 (2.2%) on Azathioprine; 1/161 (0.6%) control (serious AE) |
| Pyrexia (fever) | 4,069 | 2.8 2.8–2.9ROR 2.9 · χ² 4,855 / p <1e-300 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.2 | NCT00094458: 1/179 (0.6%) on Azathioprine; 1/161 (0.6%) control (serious AE) |
| Pneumonia (lung infection) | 3,947 | 2.9 2.9–3.0ROR 3.0 · χ² 5,092 / p <1e-300 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.0 | NCT00094458: 1/179 (0.6%) on Azathioprine; 1/161 (0.6%) control (serious AE) |
| Abdominal pain | 3,825 | 4.0 3.9–4.1ROR 4.1 · χ² 8,514 / p <1e-300 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | NCT00094458: 4/179 (2.2%) on Azathioprine; 1/161 (0.6%) control (serious AE) |
| Dyspnoea (shortness of breath) | 3,764 | 1.6 1.5–1.6ROR 1.6 · χ² 857 / p 9e-189 | 1.6 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.4 | NCT00094458: 1/17 (5.9%) on Azathioprine; 2/161 (1.2%) control |
| Malaise (feeling unwell) | 3,723 | 2.0 2.0–2.1ROR 2.1 · χ² 1,988 / p <1e-300 | 2.0 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT00094458: 1/8 (12.5%) on Azathioprine; 1/161 (0.6%) control |
| Drug intolerance | 3,698 | 9.5 9.2–9.8ROR 9.9 · χ² 27,252 / p <1e-300 | 9.2 EB05 8.9 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · ♀ 83% (drug 62%) | not reported in cached trials |
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.
- Grip strength — n=119, PRR 254.5
- Pulmonary vasculitis — n=212, PRR 160.9
- Lupus vulgaris — n=437, PRR 139.3
- Total lung capacity abnormal — n=129, PRR 122.9
- Retinitis — n=491, PRR 99.8
- Ileocaecal resection — n=93, PRR 93.1
- Capillaritis — n=73, PRR 89.4
- Elbow deformity — n=88, PRR 80.9
- Coombs positive haemolytic anaemia — n=108, PRR 72.6
- Bone erosion — n=814, PRR 71.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Azathioprine ↔ Bone-marrow suppression (pancytopenia).
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 Azathioprine?
In FDA FAERS, the most frequently co-reported reaction terms for Azathioprine are arthralgia, diarrhoea, nausea, fatigue, headache, pain. 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 Azathioprine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: - MALIGNANCY Chronic immunosuppression with azathioprine, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease.
Do FAERS signals prove that Azathioprine 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 2ffa2fce-895d-469e-8667-b078560aec5f, effective 20250204; matched on
openfda.generic_name.exact:"AZATHIOPRINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 2265 description (ChEBI)
- 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, 1,310 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
AZATHIOPRINE, 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.