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Cyclophosphamide For side effects: what 175,993 FDA adverse event reports show

Cyclophosphamide For Injection · 1,367 reaction terms · 561,290 drug–reaction co-reports · data 2026-09-14
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Drug class

Alkylating drug

FDA label, Indications wording of the closest related product

Label matched

Cyclophosphamide For Injection (Cyclophosphamide)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

175,993 reports · 96% serious · 35,641 with death outcome · 55% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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.

PubChem CID 2907 (ChEBI)

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) 9Likely indication confounding 9Lab value / disease marker 1Not in label — unassessed 20
What the badges mean

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.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Lymphoid tissue hypoplasia1392,025.4
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 hypoplasia140544.0
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 — unassessedserious n=140 · ♀ 0% (drug 55%)no trial arm names this drug
Human bocavirus infection116187.8
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 — unassessedserious n=116no trial arm names this drug
Diffuse large b-cell lymphoma recurrent1,247166.5
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% clinicianno trial arm names this drug
Mantle cell lymphoma recurrent19095.1
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% clinicianno trial arm names this drug
B-cell lymphoma recurrent23087.9
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=230no trial arm names this drug
Diffuse large b-cell lymphoma refractory39186.5
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% clinicianno trial arm names this drug
Engraftment syndrome23177.2
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 — unassessedserious n=229 · ♀ 34% (drug 55%)no trial arm names this drug
Primary amyloidosis9267.9
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 — unassessedserious n=92 · ♀ 0% (drug 55%) · 100% clinicianno trial arm names this drug
Encephalitis cytomegalovirus15566.4
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 — unassessedserious n=155 · ♀ 0% (drug 55%) · 100% clinicianno trial arm names this drug
Acute graft versus host disease in skin87154.8
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 — unassessedserious n=866 · 98% clinicianno trial arm names this drug
Acute graft versus host disease1,42653.1
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 — unassessedserious n=1,418 · 96% clinicianno trial arm names this drug
Engraft failure8852.9
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 — unassessedserious n=87 · ♀ 0% (drug 55%) · 100% clinicianno trial arm names this drug
Follicular lymphoma25650.9
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% clinicianno trial arm names this drug
Congenital aplasia8549.3
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 — unassessedserious n=85 · ♀ 0% (drug 55%) · 100% clinicianno trial arm names this drug
Diffuse large b-cell lymphoma stage iv9448.7
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% clinicianno trial arm names this drug
Chronic graft versus host disease1,05648.5
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 — unassessedserious n=1,054 · 97% clinicianno trial arm names this drug
Venoocclusive disease70046.0
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 — unassessedserious n=695 · ♀ 34% (drug 55%) · 91% clinicianno trial arm names this drug
Norovirus test positive9045.6
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 markerserious n=90no trial arm names this drug
Ovarian failure14342.7
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% clinicianno trial arm names this drug
Disseminated aspergillosis12342.2
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 — unassessedserious n=123 · ♀ 0% (drug 55%)no trial arm names this drug
Lymphoma transformation9441.8
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% clinicianno trial arm names this drug
Venoocclusive liver disease1,27341.4
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 — unassessedserious n=1,262 · 96% clinicianno trial arm names this drug
Human polyomavirus infection13240.4
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 — unassessedserious n=130 · ♀ 0% (drug 55%) · 100% clinicianno trial arm names this drug
Human herpesvirus 6 infection47739.6
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 — unassessedserious n=476 · 91% clinicianno trial arm names this drug
Acute graft versus host disease in liver18039.4
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 — unassessedserious n=179 · 95% clinicianno trial arm names this drug
Acute graft versus host disease in intestine34839.1
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 — unassessedserious n=347 · 100% clinicianno trial arm names this drug
Graft versus host disease in skin54338.8
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 — unassessedserious n=543 · 98% clinicianno trial arm names this drug
Bk virus infection81037.8
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 — unassessedserious n=808 · ♀ 31% (drug 55%) · 96% clinicianno trial arm names this drug
Chronic graft versus host disease in skin21336.2
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 — unassessedserious n=213 · 100% clinicianno trial arm names this drug
B-cell type acute leukaemia16735.9
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% clinicianno 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.

ConceptReportsPRR 95% CIReading
Neutropenia / agranulocytosis27,11514.514.4–14.7signal
Opportunistic infection6,6856.16.0–6.2signal
Thrombocytopenia9,6575.45.3–5.5signal
Interstitial lung disease3,3914.34.2–4.5signal
Anaemia8,6153.53.4–3.6signal
Serious infection19,6073.13.0–3.1signal
Liver injury6,3362.52.5–2.6signal
Heart failure3,7252.52.4–2.6signal
Hyponatraemia1,5652.32.2–2.5signal
Osteonecrosis1,0252.12.0–2.3signal
Kidney injury7,2731.91.9–2.0raised
Venous thromboembolism3,4151.91.8–2.0raised
Arrhythmia / qt2,3551.51.4–1.5raised
Pancreatitis8801.31.2–1.4raised
Gi bleeding1,7491.11.1–1.2raised
Seizure1,8381.11.1–1.2raised

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Cyclophosphamide For only as a background or rescue medication (NCT02883049, NCT00103285); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Off label use (used outside approved label)16,3462.3
2.2–2.3ROR 2.4 · calibrated p 0.858
2.2 EB05 2.2 · IC025 +1.1
3/3 methods agree
Reporting / coding artifactage-adj. PRR 1.9 · serious PRR 2.4 · 94% clinicianno trial arm names this drug
Febrile neutropenia14,52933.3
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% clinicianno trial arm names this drug
Neutropenia (low neutrophils (infection-fighting cells))10,58010.0
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% clinicianno trial arm names this drug
Drug ineffective (drug did not work)10,5731.0
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 artifactage-adj. PRR 1.2 · serious PRR 1.6 · 95% clinicianno trial arm names this drug
Pyrexia (fever)9,2423.2
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% clinicianno trial arm names this drug
Disease progression8,0968.7
8.5–8.9ROR 9.1 · calibrated p 0.044 ✓
8.2 EB05 8.0 · IC025 +3.0
3/3 methods agree
Reporting / coding artifactage-adj. PRR 7.1 · serious PRR 5.5 · 96% clinicianno trial arm names this drug
Pneumonia (lung infection)6,6672.5
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% clinicianno trial arm names this drug
Thrombocytopenia (low platelets)6,5237.3
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% clinicianno trial arm names this drug
Product use in unapproved indication6,5133.2
3.2–3.3ROR 3.3 · calibrated p 0.530
3.2 EB05 3.1 · IC025 +1.6
3/3 methods agree
Reporting / coding artifactage-adj. PRR 2.9 · serious PRR 4.0 · 95% clinicianno trial arm names this drug
Nausea6,2510.9
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 1.0no trial arm names this drug
Anaemia (low red blood cells)6,1493.9
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% clinicianno trial arm names this drug
Sepsis (blood infection)5,7296.4
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% clinicianno trial arm names this drug
Diarrhoea (diarrhea)5,4881.0
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% clinicianno trial arm names this drug
Death5,2210.7
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 reactionage-adj. PRR 0.6 · serious PRR 0.4 · 91% clinicianno trial arm names this drug
Vomiting4,9101.3
1.2–1.3ROR 1.3 · calibrated p 0.479
1.2 EB05 1.2 · IC025 +0.3Labeled adverse reaction
exact term
age-adj. PRR 1.0 · serious PRR 1.1 · 92% clinicianno 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.

✓ 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

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.