Drug · FAERS side-effect profile with label screen
Cytarabine side effects: what 59,730 FDA adverse event reports show
Drug class
Nucleoside Metabolic Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Who reports
59,730 reports · 97% serious · 13,675 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.
FDA label, Indications and Usage
What it is
DESCRIPTION Cytarabine Injection, an antineoplastic, is a sterile solution of cytarabine for intravenous, intrathecal or subcutaneous administration.
FDA label, Description section
Boxed warning
Only physicians experienced in cancer chemotherapy should use cytarabine injection. For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity.
FDA 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 — boxed warning 1Labeled adverse reaction 1Labeled (related wording) 1Likely indication confounding 8Lab value / disease marker 2Not in label — unassessed 27
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.
- 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). 1,180 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 |
|---|---|---|---|---|---|---|
| Lymphoid tissue hypoplasia | 144 | 16,580.1 5,285.1–52,013.9ROR 16,620.2 · calibrated p 6e-22 ✓ | 324.7 EB05 282.6 · IC025 +7.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=144 · ♀ 0% (drug 42%) | no trial arm names this drug |
| Thymus hypoplasia | 147 | 2,207.7 1,422.6–3,425.9ROR 2,213.1 · calibrated p 6e-20 ✓ | 288.3 EB05 251.3 · IC025 +6.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=147 · ♀ 0% (drug 42%) | no trial arm names this drug |
| Human bocavirus infection | 132 | 814.2 595.7–1,112.9ROR 816.0 · calibrated p 1e-15 ✓ | 235.0 EB05 203.2 · IC025 +6.7 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=132 · ♀ 100% (drug 42%) | no trial arm names this drug |
| Cytarabine syndrome | 39 | 374.2 237.9–588.6ROR 374.4 · calibrated p 1e-11 ✓ | 165.7 EB05 126.4 · IC025 +5.3 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 23.8 (11.9–47.6) | Labeled adverse reaction exact term | serious n=38 · ♀ 100% (drug 42%) | no trial arm names this drug |
| Geotrichum infection | 80 | 212.6 160.9–280.8ROR 212.8 · calibrated p 5e-10 ✓ | 128.0 EB05 106.1 · IC025 +5.8 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 15.2 (10.1–22.9) | Not in label — unassessed | serious n=80 · 100% clinician | no trial arm names this drug |
| Stomatococcal infection | 41 | 177.0 121.5–257.9ROR 177.1 · calibrated p 4e-9 ✓ | 111.4 EB05 85.6 · IC025 +5.1 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=40 · ♀ 0% (drug 42%) · 100% clinician | no trial arm names this drug |
| Cystitis bacterial | 110 | 168.1 133.9–211.1ROR 168.4 · calibrated p 3e-9 ✓ | 111.3 EB05 94.9 · IC025 +5.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=110 | no trial arm names this drug |
| Norovirus test positive | 104 | 166.3 131.6–210.1ROR 166.6 · calibrated p 3e-9 ✓ | 110.4 EB05 93.7 · IC025 +5.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Lab value / disease marker | serious n=104 | no trial arm names this drug |
| Mantle cell lymphoma recurrent | 125 | 144.9 117.6–178.5ROR 145.2 · calibrated p 8e-9 ✓ | 100.8 EB05 86.8 · IC025 +5.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=125 · 94% clinician | no trial arm names this drug |
| Caecitis | 124 | 131.4 106.9–161.5ROR 131.7 · calibrated p 2e-8 ✓ | 94.1 EB05 81.0 · IC025 +5.8 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=120 | no trial arm names this drug |
| Hepatosplenic candidiasis | 39 | 125.9 87.3–181.6ROR 126.0 · calibrated p 5e-8 ✓ | 88.6 EB05 67.7 · IC025 +4.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=37 · 100% clinician | no trial arm names this drug |
| Acute monocytic leukaemia | 46 | 119.5 85.4–167.0ROR 119.6 · calibrated p 6e-8 ✓ | 85.9 EB05 67.0 · IC025 +5.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=44 · 100% clinician | no trial arm names this drug |
| Diffuse large b-cell lymphoma refractory | 226 | 112.8 97.1–131.1ROR 113.2 · calibrated p 5e-8 ✓ | 84.7 EB05 75.8 · IC025 +5.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=225 · 90% clinician | no trial arm names this drug |
| Mycobacterium chelonae infection | 176 | 110.3 93.1–130.7ROR 110.7 · calibrated p 6e-8 ✓ | 83.1 EB05 73.3 · IC025 +5.8 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=176 | no trial arm names this drug |
| Acute myeloid leukaemia recurrent | 487 | 104.1 94.1–115.2ROR 104.9 · calibrated p 8e-8 ✓ | 80.0 EB05 74.2 · IC025 +6.1 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 2.8 (2.5–3.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=487 · 92% clinician | no trial arm names this drug |
| Disseminated aspergillosis | 106 | 102.6 82.6–127.4ROR 102.7 · calibrated p 1e-7 ✓ | 78.2 EB05 66.5 · IC025 +5.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=106 · ♀ 0% (drug 42%) | no trial arm names this drug |
| Diffuse large b-cell lymphoma recurrent | 481 | 101.4 91.6–112.2ROR 102.2 · calibrated p 1e-7 ✓ | 78.4 EB05 72.7 · IC025 +6.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=481 · 91% clinician | no trial arm names this drug |
| Retinoic acid syndrome | 39 | 101.3 70.9–144.7ROR 101.4 · calibrated p 2e-7 ✓ | 75.7 EB05 57.8 · IC025 +4.8 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=39 · 100% clinician | no trial arm names this drug |
| Secondary immunodeficiency | 256 | 95.8 83.4–110.0ROR 96.2 · calibrated p 2e-7 ✓ | 74.8 EB05 67.4 · IC025 +5.8 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Labeled — boxed warning synonym match | serious n=256 · ♀ 100% (drug 42%) | no trial arm names this drug |
| Abscess bacterial | 73 | 90.1 69.6–116.5ROR 90.2 · calibrated p 4e-7 ✓ | 70.4 EB05 57.8 · IC025 +5.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Labeled (related wording) related wording | serious n=72 | no trial arm names this drug |
| Congenital aplasia | 59 | 89.8 67.4–119.5ROR 89.9 · calibrated p 4e-7 ✓ | 69.9 EB05 56.2 · IC025 +5.1 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 6.9 (4.8–10.0) | Not in label — unassessed | serious n=59 · ♀ 0% (drug 42%) · 97% clinician | no trial arm names this drug |
| Enterovirus test positive | 34 | 85.1 58.5–123.8ROR 85.2 · calibrated p 9e-7 ✓ | 66.0 EB05 49.4 · IC025 +4.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Lab value / disease marker | serious n=32 | no trial arm names this drug |
| Fusarium infection | 133 | 84.8 70.1–102.4ROR 84.9 · calibrated p 5e-7 ✓ | 67.6 EB05 58.5 · IC025 +5.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 18.8 (13.4–26.6) | Not in label — unassessed | serious n=133 · 97% clinician | no trial arm names this drug |
| Malignant transformation | 86 | 83.2 65.8–105.3ROR 83.3 · calibrated p 6e-7 ✓ | 66.3 EB05 55.4 · IC025 +5.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=86 · 100% clinician | no trial arm names this drug |
| Neutropenic colitis | 384 | 80.4 72.0–89.9ROR 81.0 · calibrated p 6e-7 ✓ | 65.2 EB05 59.9 · IC025 +5.7 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 7.0 (6.1–8.2) | Not in label — unassessed | serious n=377 · 96% clinician | no trial arm names this drug |
| Central hypothyroidism | 55 | 76.0 56.8–101.7ROR 76.1 · calibrated p 1e-6 ✓ | 61.2 EB05 48.8 · IC025 +4.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=55 · ♀ 100% (drug 42%) | no trial arm names this drug |
| Febrile bone marrow aplasia | 732 | 74.4 68.7–80.5ROR 75.3 · calibrated p 9e-7 ✓ | 61.3 EB05 57.6 · IC025 +5.8 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 13.3 (11.7–15.1) | Not in label — unassessed | serious n=732 · 98% clinician | no trial arm names this drug |
| Hypofibrinogenaemia | 167 | 73.0 61.8–86.3ROR 73.2 · calibrated p 1e-6 ✓ | 60.1 EB05 52.8 · IC025 +5.4 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=167 · 96% clinician | no trial arm names this drug |
| Central nervous system fungal infection | 36 | 70.7 49.4–101.1ROR 70.7 · calibrated p 3e-6 ✓ | 57.1 EB05 43.1 · IC025 +4.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=36 · ♀ 0% (drug 42%) · 94% clinician | no trial arm names this drug |
| Treatment related secondary malignancy | 34 | 69.5 48.1–100.4ROR 69.5 · calibrated p 3e-6 ✓ | 56.3 EB05 42.1 · IC025 +4.4 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=34 | no trial arm names this drug |
| Pseudomonal sepsis | 291 | 69.4 61.2–78.7ROR 69.8 · calibrated p 2e-6 ✓ | 57.8 EB05 52.4 · IC025 +5.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 13.8 (11.3–17.0) | Not in label — unassessed | serious n=291 | no trial arm names this drug |
| Chloroma | 69 | 68.5 52.9–88.7ROR 68.6 · calibrated p 2e-6 ✓ | 56.5 EB05 46.1 · IC025 +5.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 6.9 (4.9–9.7) | Not in label — unassessed | serious n=69 · 97% clinician | no trial arm names this drug |
| Blood stem cell transplant failure | 35 | 67.9 47.3–97.6ROR 68.0 · calibrated p 4e-6 ✓ | 55.3 EB05 41.6 · IC025 +4.4 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=35 · ♀ 0% (drug 42%) · 100% clinician | no trial arm names this drug |
| Myelopathy | 299 | 65.4 57.8–73.9ROR 65.7 · calibrated p 2e-6 ✓ | 54.9 EB05 49.9 · IC025 +5.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=299 · 96% clinician | no trial arm names this drug |
| Antithrombin iii decreased | 42 | 65.3 47.0–90.9ROR 65.4 · calibrated p 4e-6 ✓ | 53.8 EB05 41.5 · IC025 +4.6 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=42 · 100% clinician | no trial arm names this drug |
| Corona virus infection | 67 | 63.8 49.1–82.7ROR 63.8 · calibrated p 4e-6 ✓ | 53.2 EB05 43.3 · IC025 +4.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: only this drug | Not in label — unassessed | serious n=67 | no trial arm names this drug |
| Leukaemia recurrent | 258 | 63.2 55.3–72.1ROR 63.4 · calibrated p 3e-6 ✓ | 53.4 EB05 48.1 · IC025 +5.4 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 19.4 (15.1–24.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=257 · 94% clinician | no trial arm names this drug |
| Parainfluenzae virus infection | 235 | 62.8 54.6–72.1ROR 63.0 · calibrated p 3e-6 ✓ | 53.1 EB05 47.6 · IC025 +5.4 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 34.9 (25.1–48.6) | Not in label — unassessed | serious n=234 | no trial arm names this drug |
| Aplasia | 296 | 61.0 54.0–69.1ROR 61.3 · calibrated p 4e-6 ✓ | 51.9 EB05 47.1 · IC025 +5.4 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 13.9 (11.3–17.0) | Not in label — unassessed | serious n=296 · 94% clinician | no trial arm names this drug |
| T-cell type acute leukaemia | 30 | 59.9 40.7–88.3ROR 59.9 · calibrated p 9e-6 ✓ | 49.7 EB05 36.5 · IC025 +4.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 22.8 (10.5–49.8) | Likely indication confounding shares a disease stem with the indications wording | serious n=30 · 100% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Cytarabine only as a background or rescue medication (NCT01190930, NCT02883049); 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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 7,662 | 45.9 44.9–46.9ROR 52.5 · calibrated p 1e-5 ✓ | 40.6 EB05 39.9 · IC025 +5.3 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 4.7 (4.6–4.8) | Not in label — unassessed | serious PRR 23.9 · 96% clinician | no trial arm names this drug |
| Off label use (used outside approved label) | 5,107 | 2.1 2.0–2.1ROR 2.2 · calibrated p 0.965 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 2.7 (2.6–2.8) | Reporting / coding artifact | serious PRR 2.2 · 95% clinician | no trial arm names this drug |
| Pyrexia (fever) | 4,203 | 4.3 4.2–4.4ROR 4.6 · calibrated p 0.289 | 4.3 EB05 4.2 · IC025 +2.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 3.0 (2.9–3.1) | Labeled adverse reaction exact term | serious PRR 3.1 · 93% clinician | no trial arm names this drug |
| Neutropenia (low neutrophils (infection-fighting cells)) | 3,686 | 9.8 9.5–10.1ROR 10.4 · calibrated p 0.028 ✓ | 9.5 EB05 9.3 · IC025 +3.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 1.9 (1.8–1.9) | Not in label — unassessed | serious PRR 5.8 · 96% clinician | no trial arm names this drug |
| Drug ineffective (drug did not work) | 3,161 | 0.8 0.8–0.9ROR 0.8 · calibrated p 0.203 | 0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Nucleoside Metabolic Inhibitors: PRR 2.7 (2.6–2.8) | Reporting / coding artifact | serious PRR 1.4 · 94% clinician | no trial arm names this drug |
| Thrombocytopenia (low platelets) | 2,966 | 9.6 9.2–9.9ROR 10.0 · calibrated p 0.032 ✓ | 9.3 EB05 9.1 · IC025 +3.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 2.2 (2.1–2.2) | Labeled — boxed warning exact term | serious PRR 5.6 · 96% clinician | no trial arm names this drug |
| Sepsis (blood infection) | 2,953 | 9.5 9.2–9.9ROR 10.0 · calibrated p 0.033 ✓ | 9.3 EB05 9.0 · IC025 +3.2 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 3.7 (3.5–3.8) | Labeled — boxed warning exact term | serious PRR 5.5 · 95% clinician | no trial arm names this drug |
| Disease progression | 2,773 | 8.4 8.1–8.7ROR 8.8 · calibrated p 0.049 ✓ | 8.2 EB05 8.0 · IC025 +3.0 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 1.6 (1.5–1.6) | Reporting / coding artifact | serious PRR 5.5 · 96% clinician | no trial arm names this drug |
| Pneumonia (lung infection) | 2,357 | 2.6 2.5–2.7ROR 2.6 · calibrated p 0.757 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 2.4 (2.3–2.5) | Labeled — boxed warning synonym match | serious PRR 1.6 · 94% clinician | no trial arm names this drug |
| Myelosuppression | 2,263 | 25.0 23.9–26.0ROR 25.9 · calibrated p 6e-4 ✓ | 23.3 EB05 22.5 · IC025 +4.5 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 2.2 (2.1–2.4) | Not in label — unassessed | serious PRR 13.8 | no trial arm names this drug |
| Pancytopenia (all blood cells low) | 2,154 | 14.1 13.5–14.7ROR 14.6 · calibrated p 0.008 ✓ | 13.6 EB05 13.1 · IC025 +3.7 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 3.8 (3.6–4.0) | Labeled — boxed warning synonym match | serious PRR 8.0 · 95% clinician | no trial arm names this drug |
| Death | 2,049 | 0.8 0.8–0.9ROR 0.8 · calibrated p 0.200 | 0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Nucleoside Metabolic Inhibitors: PRR 0.8 (0.7–0.8) | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.5 · 91% clinician | no trial arm names this drug |
| Septic shock | 1,880 | 15.9 15.2–16.7ROR 16.4 · calibrated p 0.005 ✓ | 15.3 EB05 14.7 · IC025 +3.9 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 4.8 (4.6–5.1) | Not in label — unassessed | serious PRR 8.9 · 96% clinician | no trial arm names this drug |
| Anaemia (low red blood cells) | 1,870 | 3.5 3.3–3.6ROR 3.5 · calibrated p 0.474 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Nucleoside Metabolic Inhibitors: PRR 1.6 (1.5–1.7) | Labeled — boxed warning exact term | serious PRR 2.2 · 94% clinician | no trial arm names this drug |
| Nausea | 1,869 | 0.8 0.8–0.9ROR 0.8 · calibrated p 0.199 | 0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Nucleoside Metabolic Inhibitors: PRR 0.8 (0.7–0.8) | Labeled — boxed warning exact term | serious PRR 0.9 · 91% 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=147, PRR 2,207.7
- Human bocavirus infection — n=132, PRR 814.2
- Geotrichum infection — n=80, PRR 212.6
- Stomatococcal infection — n=41, PRR 177.0
- Cystitis bacterial — n=110, PRR 168.1
- Caecitis — n=124, PRR 131.4
- Hepatosplenic candidiasis — n=39, PRR 125.9
- Mycobacterium chelonae infection — n=176, PRR 110.3
- Disseminated aspergillosis — n=106, PRR 102.6
- Retinoic acid syndrome — n=39, PRR 101.3
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 Cytarabine?
In FDA FAERS, the most frequently co-reported reaction terms for Cytarabine are febrile neutropenia, pyrexia, neutropenia, thrombocytopenia, sepsis, pneumonia. 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 Cytarabine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Only physicians experienced in cancer chemotherapy should use cytarabine injection. For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity.
Do FAERS signals prove that Cytarabine 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 8105e590-fc7e-45b7-9604-c2d0d1be5eac, effective 20240408; matched on
openfda.generic_name.exact:"CYTARABINE") - 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, 1,220 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
CYTARABINE, 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.