Cyclophosphamide For side effects: what 175,993 FDA adverse event reports show
Drug class
Alkylating drug
Label matched
Cyclophosphamide For Injection (Cyclophosphamide)
Who reports
175,993 reports · 96% serious · 35,641 with death outcome · 55% female
Used for
Cyclophosphamide for Injection is an alkylating drug indicated for treatment of adults and pediatric patients with: • Malignant Diseases: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burk.
What it is
Cyclophosphamide is a phosphorodiamide that is 1,3,2-oxazaphosphinan-2-amine 2-oxide substituted by two 2-chloroethyl groups at the amino nitrogen atom.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,327 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 |
|---|---|---|---|---|---|---|
| Lymphoid tissue hypoplasia | 139 | 2,025.4 993.2–4,130.4ROR 2,027.0 · calibrated p 3e-17 ✓ | 109.5 EB05 95.1 · IC025 +6.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=139 · ♀ 0% (drug 55%) | no trial arm names this drug |
| Thymus hypoplasia | 140 | 544.0 366.7–806.9ROR 544.4 · calibrated p 2e-13 ✓ | 95.6 EB05 83.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=140 · ♀ 0% (drug 55%) | no trial arm names this drug |
| Human bocavirus infection | 116 | 187.8 140.0–252.0ROR 187.9 · calibrated p 1e-9 ✓ | 71.7 EB05 61.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=116 | no trial arm names this drug |
| Diffuse large b-cell lymphoma recurrent | 1,247 | 166.5 152.7–181.5ROR 167.7 · calibrated p 2e-9 ✓ | 69.1 EB05 65.9 · IC025 +6.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=1,246 · 93% clinician | no trial arm names this drug |
| Cystitis viral | 177 | 103.7 84.7–126.9ROR 103.8 · calibrated p 1e-7 ✓ | 55.0 EB05 48.6 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=174 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Mantle cell lymphoma recurrent | 190 | 95.1 78.5–115.1ROR 95.2 · calibrated p 2e-7 ✓ | 52.5 EB05 46.6 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=190 · ♀ 30% (drug 55%) · 93% clinician | no trial arm names this drug |
| B-cell lymphoma recurrent | 230 | 87.9 74.1–104.3ROR 88.0 · calibrated p 3e-7 ✓ | 50.3 EB05 45.1 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=230 | no trial arm names this drug |
| Diffuse large b-cell lymphoma refractory | 391 | 86.5 75.9–98.6ROR 86.7 · calibrated p 4e-7 ✓ | 50.0 EB05 45.9 · IC025 +5.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=391 · 91% clinician | no trial arm names this drug |
| Blood stem cell transplant failure | 89 | 83.7 63.7–109.8ROR 83.7 · calibrated p 7e-7 ✓ | 48.6 EB05 40.7 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=88 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Viral haemorrhagic cystitis | 284 | 80.2 68.9–93.2ROR 80.3 · calibrated p 6e-7 ✓ | 47.8 EB05 43.3 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=284 · 100% clinician | no trial arm names this drug |
| Engraftment syndrome | 231 | 77.2 65.3–91.1ROR 77.3 · calibrated p 9e-7 ✓ | 46.7 EB05 41.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=229 · ♀ 34% (drug 55%) | no trial arm names this drug |
| Primary amyloidosis | 92 | 67.9 52.5–87.8ROR 67.9 · calibrated p 3e-6 ✓ | 42.9 EB05 36.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=92 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Encephalitis cytomegalovirus | 155 | 66.4 54.5–80.9ROR 66.5 · calibrated p 3e-6 ✓ | 42.5 EB05 37.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=155 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Cytomegalovirus infection reactivation | 1,352 | 55.1 51.6–58.8ROR 55.5 · calibrated p 7e-6 ✓ | 37.7 EB05 36.1 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=1,348 · 98% clinician | no trial arm names this drug |
| Acute graft versus host disease in skin | 871 | 54.8 50.6–59.4ROR 55.1 · calibrated p 7e-6 ✓ | 37.6 EB05 35.5 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=866 · 98% clinician | no trial arm names this drug |
| Acute graft versus host disease | 1,426 | 53.1 49.9–56.5ROR 53.5 · calibrated p 9e-6 ✓ | 36.8 EB05 35.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=1,418 · 96% clinician | no trial arm names this drug |
| Engraft failure | 88 | 52.9 41.1–68.0ROR 52.9 · calibrated p 1e-5 ✓ | 36.4 EB05 30.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=87 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Follicular lymphoma | 256 | 50.9 44.0–59.0ROR 51.0 · calibrated p 1e-5 ✓ | 35.7 EB05 32.1 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=251 · 93% clinician | no trial arm names this drug |
| Cystitis bacterial | 100 | 49.4 39.1–62.4ROR 49.4 · calibrated p 2e-5 ✓ | 34.8 EB05 29.4 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=100 | no trial arm names this drug |
| Congenital aplasia | 85 | 49.3 38.3–63.5ROR 49.3 · calibrated p 2e-5 ✓ | 34.7 EB05 28.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=85 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Diffuse large b-cell lymphoma stage iv | 94 | 48.7 38.3–62.0ROR 48.7 · calibrated p 2e-5 ✓ | 34.4 EB05 29.0 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=94 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Chronic graft versus host disease | 1,056 | 48.5 45.2–52.1ROR 48.8 · calibrated p 2e-5 ✓ | 34.5 EB05 32.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=1,054 · 97% clinician | no trial arm names this drug |
| Cystitis haemorrhagic | 1,125 | 46.1 43.1–49.4ROR 46.4 · calibrated p 2e-5 ✓ | 33.3 EB05 31.7 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=1,120 · 95% clinician | no trial arm names this drug |
| Venoocclusive disease | 700 | 46.0 42.1–50.2ROR 46.2 · calibrated p 2e-5 ✓ | 33.2 EB05 31.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=695 · ♀ 34% (drug 55%) · 91% clinician | no trial arm names this drug |
| Norovirus test positive | 90 | 45.6 35.8–58.2ROR 45.6 · calibrated p 3e-5 ✓ | 32.9 EB05 27.5 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=90 | no trial arm names this drug |
| Ovarian failure | 143 | 42.7 35.3–51.8ROR 42.8 · calibrated p 4e-5 ✓ | 31.4 EB05 27.3 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=141 · ♀ 100% (drug 55%) · 100% clinician | no trial arm names this drug |
| Disseminated aspergillosis | 123 | 42.2 34.3–51.8ROR 42.2 · calibrated p 5e-5 ✓ | 31.1 EB05 26.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=123 · ♀ 0% (drug 55%) | no trial arm names this drug |
| Lymphoma transformation | 94 | 41.8 33.0–52.9ROR 41.8 · calibrated p 5e-5 ✓ | 30.9 EB05 26.0 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=94 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Venoocclusive liver disease | 1,273 | 41.4 38.9–44.2ROR 41.7 · calibrated p 4e-5 ✓ | 30.8 EB05 29.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=1,262 · 96% clinician | no trial arm names this drug |
| Human polyomavirus infection | 132 | 40.4 33.1–49.2ROR 40.4 · calibrated p 6e-5 ✓ | 30.1 EB05 26.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=130 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Human herpesvirus 6 infection | 477 | 39.6 35.7–43.9ROR 39.7 · calibrated p 6e-5 ✓ | 29.8 EB05 27.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=476 · 91% clinician | no trial arm names this drug |
| Acute graft versus host disease in liver | 180 | 39.4 33.3–46.7ROR 39.5 · calibrated p 6e-5 ✓ | 29.6 EB05 26.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=179 · 95% clinician | no trial arm names this drug |
| Hepatitis b reactivation | 791 | 39.3 36.3–42.6ROR 39.5 · calibrated p 6e-5 ✓ | 29.6 EB05 27.9 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=778 · 94% clinician | no trial arm names this drug |
| Acute graft versus host disease in intestine | 348 | 39.1 34.6–44.2ROR 39.2 · calibrated p 6e-5 ✓ | 29.5 EB05 27.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=347 · 100% clinician | no trial arm names this drug |
| Graft versus host disease in skin | 543 | 38.8 35.2–42.8ROR 38.9 · calibrated p 6e-5 ✓ | 29.4 EB05 27.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=543 · 98% clinician | no trial arm names this drug |
| Bk virus infection | 810 | 37.8 35.0–40.9ROR 38.0 · calibrated p 7e-5 ✓ | 28.8 EB05 27.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=808 · ♀ 31% (drug 55%) · 96% clinician | no trial arm names this drug |
| Secondary immunodeficiency | 283 | 36.8 32.2–42.1ROR 36.9 · calibrated p 9e-5 ✓ | 28.2 EB05 25.5 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=283 · ♀ 100% (drug 55%) | no trial arm names this drug |
| Chronic graft versus host disease in skin | 213 | 36.2 31.0–42.2ROR 36.2 · calibrated p 1e-4 ✓ | 27.8 EB05 24.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=213 · 100% clinician | no trial arm names this drug |
| B-cell type acute leukaemia | 167 | 35.9 30.2–42.7ROR 36.0 · calibrated p 1e-4 ✓ | 27.6 EB05 24.3 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=167 · 95% clinician | no trial arm names this drug |
| Complications of bone marrow transplant | 83 | 34.8 27.2–44.5ROR 34.8 · calibrated p 1e-4 ✓ | 26.9 EB05 22.4 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=82 | no trial arm names this drug |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Neutropenia / agranulocytosis | 27,115 | 14.514.4–14.7 | signal |
| Opportunistic infection | 6,685 | 6.16.0–6.2 | signal |
| Thrombocytopenia | 9,657 | 5.45.3–5.5 | signal |
| Interstitial lung disease | 3,391 | 4.34.2–4.5 | signal |
| Anaemia | 8,615 | 3.53.4–3.6 | signal |
| Serious infection | 19,607 | 3.13.0–3.1 | signal |
| Liver injury | 6,336 | 2.52.5–2.6 | signal |
| Heart failure | 3,725 | 2.52.4–2.6 | signal |
| Hyponatraemia | 1,565 | 2.32.2–2.5 | signal |
| Osteonecrosis | 1,025 | 2.12.0–2.3 | signal |
| Kidney injury | 7,273 | 1.91.9–2.0 | raised |
| Venous thromboembolism | 3,415 | 1.91.8–2.0 | raised |
| Arrhythmia / qt | 2,355 | 1.51.4–1.5 | raised |
| Pancreatitis | 880 | 1.31.2–1.4 | raised |
| Gi bleeding | 1,749 | 1.11.1–1.2 | raised |
| Seizure | 1,838 | 1.11.1–1.2 | raised |
Trial evidence (ClinicalTrials.gov)
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) | 16,346 | 2.3 2.2–2.3ROR 2.4 · calibrated p 0.858 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 1.9 · serious PRR 2.4 · 94% clinician | no trial arm names this drug |
| Febrile neutropenia | 14,529 | 33.3 32.7–33.9ROR 36.2 · calibrated p 9e-5 ✓ | 26.1 EB05 25.8 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 23.3 · serious PRR 15.6 · 96% clinician | no trial arm names this drug |
| Neutropenia (low neutrophils (infection-fighting cells)) | 10,580 | 10.0 9.8–10.2ROR 10.6 · calibrated p 0.026 ✓ | 9.3 EB05 9.2 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 7.4 · serious PRR 5.7 · 95% clinician | no trial arm names this drug |
| Drug ineffective (drug did not work) | 10,573 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.277 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 1.2 · serious PRR 1.6 · 95% clinician | no trial arm names this drug |
| Pyrexia (fever) | 9,242 | 3.2 3.2–3.3ROR 3.4 · calibrated p 0.519 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 2.4 · 92% clinician | no trial arm names this drug |
| Disease progression | 8,096 | 8.7 8.5–8.9ROR 9.1 · calibrated p 0.044 ✓ | 8.2 EB05 8.0 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 7.1 · serious PRR 5.5 · 96% clinician | no trial arm names this drug |
| Pneumonia (lung infection) | 6,667 | 2.5 2.4–2.5ROR 2.5 · calibrated p 0.793 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 1.5 · 94% clinician | no trial arm names this drug |
| Thrombocytopenia (low platelets) | 6,523 | 7.3 7.2–7.5ROR 7.6 · calibrated p 0.078 | 7.0 EB05 6.8 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.5 · serious PRR 4.3 · 96% clinician | no trial arm names this drug |
| Product use in unapproved indication | 6,513 | 3.2 3.2–3.3ROR 3.3 · calibrated p 0.530 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 2.9 · serious PRR 4.0 · 95% clinician | no trial arm names this drug |
| Nausea | 6,251 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.269 | 0.9 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | age-adj. PRR 0.8 · serious PRR 1.0 | no trial arm names this drug |
| Anaemia (low red blood cells) | 6,149 | 3.9 3.8–4.0ROR 4.0 · calibrated p 0.370 | 3.8 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.2 · serious PRR 2.5 · 94% clinician | no trial arm names this drug |
| Sepsis (blood infection) | 5,729 | 6.4 6.2–6.6ROR 6.6 · calibrated p 0.117 | 6.1 EB05 6.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.0 · serious PRR 3.7 · 94% clinician | no trial arm names this drug |
| Diarrhoea (diarrhea) | 5,488 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.318 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | age-adj. PRR 0.9 · serious PRR 1.0 · 91% clinician | no trial arm names this drug |
| Death | 5,221 | 0.7 0.7–0.7ROR 0.7 · calibrated p 0.136 | 0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | age-adj. PRR 0.6 · serious PRR 0.4 · 91% clinician | no trial arm names this drug |
| Vomiting | 4,910 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.479 | 1.2 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | age-adj. PRR 1.0 · serious PRR 1.1 · 92% clinician | no trial arm names this drug |
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.
- Thymus hypoplasia — n=140, PRR 544.0
- Human bocavirus infection — n=116, PRR 187.8
- Engraftment syndrome — n=231, PRR 77.2
- Primary amyloidosis — n=92, PRR 67.9
- Encephalitis cytomegalovirus — n=155, PRR 66.4
- Acute graft versus host disease in skin — n=871, PRR 54.8
- Acute graft versus host disease — n=1,426, PRR 53.1
- Engraft failure — n=88, PRR 52.9
- Congenital aplasia — n=85, PRR 49.3
- Chronic graft versus host disease — n=1,056, PRR 48.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Cyclophosphamide ↔ Haemorrhagic cystitis.
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 Cyclophosphamide For?
In FDA FAERS, the most frequently co-reported reaction terms for Cyclophosphamide For are febrile neutropenia, neutropenia, pyrexia, pneumonia, thrombocytopenia, nausea. 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 Cyclophosphamide For have an FDA boxed warning?
No. The FDA label retrieved for Cyclophosphamide For has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cyclophosphamide 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 6fde2705-a2d8-4d48-9618-b9d99d051373, effective 20250103; matched on
openfda.generic_name.exact:"CYCLOPHOSPHAMIDE FOR INJECTION") - PubChem CID 2907 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, 1,367 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
CYCLOPHOSPHAMIDE FOR, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.