Drug · FAERS side-effect profile with label screen
Anti-Thymocyte Globulin (Rabbit) side effects: what 8,019 FDA adverse event reports show
Drug class
Immunoglobulin G
FDA label (Established Pharmacologic Class)
Brand names
Thymoglobulin
openFDA label
Who reports
8,019 reports · 97% serious · 2,038 with death outcome · 43% female
openFDA FAERS counts, all years, deduplication not applied
Used for
THYMOGLOBULIN is indicated for the prophylaxis and treatment of acute rejection in adult and pediatric patients receiving a kidney transplant in conjunction with concomitant immunosuppression. THYMOGLOBULIN is an immunoglobulin G indicated for the prophylaxis and treatment of acute rejection in adult and pediatric patients receiving a kidney transplant in conjunction with concomitant immunosuppression. ( 1 )
FDA label, Indications and Usage
What it is
THYMOGLOBULIN ® (anti-thymocyte globulin [rabbit]) is a purified, pasteurized, immunoglobulin G, obtained by immunization of rabbits with human thymocytes. This immunosuppressive product contains cytotoxic antibodies directed against antigens expressed on human T-lymphocytes.
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) 8Likely indication confounding 3Lab value / disease marker 2Not in label — unassessed 26
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.
- 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. 974 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 |
|---|---|---|---|---|---|---|
| Protothecosis | 30 | 1,228.2 795.6–1,896.0ROR 1,232.8 · χ² 24,094 / p <1e-300 | 542.6 EB05 398.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 100% (drug 43%) · 90% clinician | no trial data cached |
| Pyelonephritis fungal | 15 | 678.7 384.5–1,198.2ROR 680.0 · χ² 7,508 / p <1e-300 | 318.8 EB05 205.1 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Delayed graft function | 110 | 482.5 394.1–590.7ROR 489.2 · χ² 44,121 / p <1e-300 | 379.7 EB05 323.8 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=110 · 98% clinician | no trial data cached |
| Encephalitis cytomegalovirus | 66 | 471.5 363.0–612.4ROR 475.4 · χ² 25,803 / p <1e-300 | 357.4 EB05 290.7 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 7% (drug 43%) · 94% clinician | no trial data cached |
| Retinopathy haemorrhagic | 10 | 460.6 235.1–902.3ROR 461.1 · χ² 3,511 / p <1e-300 | 224.1 EB05 130.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Donor specific antibody present | 22 | 446.8 284.3–702.2ROR 448.0 · χ² 7,965 / p <1e-300 | 286.2 EB05 199.2 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=22 · 95% clinician | no trial data cached |
| Perinephric abscess | 21 | 416.6 262.9–660.3ROR 417.7 · χ² 7,143 / p <1e-300 | 270.5 EB05 186.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 67% (drug 43%) · 100% clinician | no trial data cached |
| Chimerism | 12 | 407.2 221.6–748.3ROR 407.8 · χ² 3,856 / p <1e-300 | 225.8 EB05 137.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Renal graft loss | 11 | 405.3 214.7–765.0ROR 405.8 · χ² 3,492 / p <1e-300 | 218.2 EB05 130.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Heart transplant rejection | 138 | 398.1 333.2–475.6ROR 405.1 · χ² 47,014 / p <1e-300 | 329.2 EB05 285.7 · IC025 +7.0 3/3 methods agree | Labeled (related wording) related wording | serious n=138 | no trial data cached |
| Graft loss | 93 | 380.1 306.1–472.1ROR 384.6 · χ² 30,320 / p <1e-300 | 310.3 EB05 260.8 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=93 · ♀ 16% (drug 43%) · 97% clinician | no trial data cached |
| Engraft failure | 36 | 377.4 266.2–535.1ROR 379.1 · χ² 11,464 / p <1e-300 | 280.3 EB05 211.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=36 · 100% clinician | no trial data cached |
| Graft versus host disease in intestine | 16 | 362.0 214.6–610.6ROR 362.7 · χ² 4,739 / p <1e-300 | 230.4 EB05 150.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Pancreas transplant rejection | 23 | 333.3 216.0–514.2ROR 334.2 · χ² 6,456 / p <1e-300 | 237.2 EB05 166.5 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=23 · 96% clinician | no trial data cached |
| New onset diabetes after transplantation | 18 | 311.6 191.1–507.9ROR 312.3 · χ² 4,698 / p <1e-300 | 214.9 EB05 143.8 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=18 | no trial data cached |
| Emphysematous pyelonephritis | 17 | 265.7 161.4–437.6ROR 266.3 · χ² 3,828 / p <1e-300 | 189.9 EB05 125.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Adenoviral hepatitis | 21 | 260.4 166.3–407.7ROR 261.1 · χ² 4,696 / p <1e-300 | 194.9 EB05 134.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=21 · 95% clinician | no trial data cached |
| Epstein-barr viraemia | 97 | 256.3 208.3–315.4ROR 259.5 · χ² 22,209 / p <1e-300 | 223.0 EB05 188.2 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=96 · 97% clinician | no trial data cached |
| Renal graft infection | 19 | 233.4 146.0–373.0ROR 233.9 · χ² 3,821 / p <1e-300 | 176.4 EB05 119.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Chronic allograft nephropathy | 64 | 231.2 179.2–298.3ROR 233.0 · χ² 13,251 / p <1e-300 | 199.7 EB05 161.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=64 · ♀ 13% (drug 43%) · 94% clinician | no trial data cached |
| Acute graft versus host disease in skin | 223 | 230.0 200.9–263.3ROR 236.5 · χ² 46,472 / p <1e-300 | 207.5 EB05 185.6 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=220 · 99% clinician | no trial data cached |
| Serum sickness | 217 | 221.5 193.1–254.0ROR 227.6 · χ² 43,664 / p <1e-300 | 200.5 EB05 179.1 · IC025 +6.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=208 · 95% clinician | no trial data cached |
| Polyomavirus viraemia | 78 | 221.3 175.8–278.6ROR 223.5 · χ² 15,553 / p <1e-300 | 194.3 EB05 160.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=77 · 100% clinician | no trial data cached |
| Acute graft versus host disease in intestine | 106 | 213.8 175.6–260.3ROR 216.6 · χ² 20,534 / p <1e-300 | 190.7 EB05 162.1 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=105 · 99% clinician | no trial data cached |
| Graft dysfunction | 21 | 204.4 131.1–318.6ROR 204.9 · χ² 3,752 / p <1e-300 | 161.8 EB05 111.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Urinary tract candidiasis | 13 | 193.8 110.3–340.4ROR 194.1 · χ² 2,143 / p <1e-300 | 143.0 EB05 88.9 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Acute graft versus host disease in liver | 49 | 190.6 142.7–254.6ROR 191.8 · χ² 8,431 / p <1e-300 | 166.2 EB05 130.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=47 · 100% clinician | no trial data cached |
| Colitis erosive | 10 | 185.5 97.7–352.4ROR 185.8 · χ² 1,544 / p <1e-300 | 130.7 EB05 75.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Epstein-barr virus associated lymphoproliferative disorder | 117 | 184.9 153.5–222.8ROR 187.6 · χ² 19,799 / p <1e-300 | 167.9 EB05 143.9 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | serious n=117 · 94% clinician | no trial data cached |
| Cytomegalovirus test positive | 115 | 181.6 150.5–219.2ROR 184.3 · χ² 19,132 / p <1e-300 | 165.1 EB05 141.3 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious n=113 · 97% clinician | no trial data cached |
| Bk virus infection | 215 | 179.4 156.5–205.6ROR 184.3 · χ² 35,500 / p <1e-300 | 165.4 EB05 147.6 · IC025 +6.7 3/3 methods agree | Labeled (related wording) related wording | serious n=214 · 95% clinician | no trial data cached |
| Complications of transplanted kidney | 142 | 177.8 150.2–210.4ROR 181.0 · χ² 23,190 / p <1e-300 | 162.8 EB05 141.5 · IC025 +6.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=140 · 94% clinician | no trial data cached |
| Aeromonas infection | 11 | 175.1 95.1–322.4ROR 175.4 · χ² 1,624 / p <1e-300 | 128.2 EB05 76.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Genital herpes simplex | 13 | 171.9 98.1–301.3ROR 172.2 · χ² 1,914 / p <1e-300 | 130.8 EB05 81.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Cytomegalovirus gastrointestinal infection | 18 | 167.0 103.7–268.9ROR 167.4 · χ² 2,636 / p <1e-300 | 134.8 EB05 90.2 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Polyomavirus-associated nephropathy | 133 | 158.7 133.4–188.8ROR 161.3 · χ² 19,483 / p <1e-300 | 146.4 EB05 126.7 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=133 · 99% clinician | no trial data cached |
| Transplant rejection | 446 | 154.2 140.5–169.3ROR 163.3 · χ² 63,949 / p <1e-300 | 144.7 EB05 133.8 · IC025 +6.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 87.1 · 95% clinician | no trial data cached |
| Acute graft versus host disease | 257 | 154.1 136.1–174.4ROR 159.2 · χ² 36,754 / p <1e-300 | 143.9 EB05 129.8 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=255 · 96% clinician | no trial data cached |
| Acute cholecystitis necrotic | 10 | 149.1 78.8–281.9ROR 149.3 · χ² 1,254 / p 6e-275 | 111.6 EB05 64.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Renal transplant failure | 53 | 148.1 112.4–195.2ROR 149.1 · χ² 7,185 / p <1e-300 | 133.5 EB05 105.9 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=53 · 94% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Pyrexia (fever) | 678 | 5.1 4.8–5.5ROR 5.5 · χ² 2,282 / p <1e-300 | 5.1 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 95% clinician | no trial data cached |
| Off label use (used outside approved label) | 650 | 2.0 1.8–2.1ROR 2.0 · χ² 317 / p 3e-71 | 2.0 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.1 · 95% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 503 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.499 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.7 · 95% clinician | no trial data cached |
| Cytomegalovirus infection | 451 | 72.9 66.5–79.8ROR 77.1 · χ² 31,040 / p <1e-300 | 70.7 EB05 65.4 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 41.4 · 93% clinician | no trial data cached |
| Transplant rejection | 446 | 154.2 140.5–169.3ROR 163.3 · χ² 63,949 / p <1e-300 | 144.7 EB05 133.8 · IC025 +6.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 87.1 · 95% clinician | no trial data cached |
| Febrile neutropenia | 327 | 13.0 11.7–14.4ROR 13.5 · χ² 3,594 / p <1e-300 | 12.9 EB05 11.7 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 · 98% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 306 | 1.2 1.1–1.4ROR 1.3 · χ² 15 / p 6e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.3 · 93% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 280 | 6.6 5.9–7.4ROR 6.8 · χ² 1,323 / p 6e-290 | 6.5 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 274 | 6.4 5.7–7.2ROR 6.6 · χ² 1,255 / p 3e-275 | 6.4 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 96% clinician | no trial data cached |
| Pneumonia (lung infection) | 265 | 2.1 1.9–2.4ROR 2.2 · χ² 163 / p 1e-37 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.3 · 97% clinician | no trial data cached |
| Product use in unapproved indication | 258 | 2.8 2.5–3.1ROR 2.8 · χ² 292 / p 1e-65 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 · 94% clinician | no trial data cached |
| Acute graft versus host disease | 257 | 154.1 136.1–174.4ROR 159.2 · χ² 36,754 / p <1e-300 | 143.9 EB05 129.8 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=255 · 96% clinician | no trial data cached |
| Hypotension (low blood pressure) | 250 | 3.3 2.9–3.7ROR 3.3 · χ² 394 / p 5e-88 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 · 95% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 249 | 4.3 3.8–4.8ROR 4.4 · χ² 626 / p 2e-138 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · 96% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 239 | 11.3 9.9–12.8ROR 11.6 · χ² 2,220 / p <1e-300 | 11.2 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 91% clinician | no trial data cached |
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.
- Protothecosis — n=30, PRR 1,228.2
- Delayed graft function — n=110, PRR 482.5
- Encephalitis cytomegalovirus — n=66, PRR 471.5
- Perinephric abscess — n=21, PRR 416.6
- Graft loss — n=93, PRR 380.1
- Engraft failure — n=36, PRR 377.4
- Adenoviral hepatitis — n=21, PRR 260.4
- Epstein-barr viraemia — n=97, PRR 256.3
- Chronic allograft nephropathy — n=64, PRR 231.2
- Acute graft versus host disease in skin — n=223, PRR 230.0
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 Anti-Thymocyte Globulin (Rabbit)?
In FDA FAERS, the most frequently co-reported reaction terms for Anti-Thymocyte Globulin (Rabbit) are pyrexia, cytomegalovirus infection, transplant rejection, febrile neutropenia, diarrhoea, thrombocytopenia. 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 Anti-Thymocyte Globulin (Rabbit) have an FDA boxed warning?
No. The FDA label retrieved for Anti-Thymocyte Globulin (Rabbit) has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Anti-Thymocyte Globulin (Rabbit) 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 bbd8ab99-552e-4b81-aca4-6b0c7af8b9ae, effective 20260624; matched on
openfda.generic_name.exact:"ANTI-THYMOCYTE GLOBULIN (RABBIT)") - 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, 1,014 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
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.