Methotrexate vs Cytarabine: side effects in FDA adverse event reports
At a glance
| Methotrexate | Cytarabine | |
|---|---|---|
| Drug class | – | Nucleoside Metabolic Inhibitor |
| Brand names | – | – |
| FAERS reports | 483,097 | 59,730 |
| Serious | 73% | 97% |
| Death outcome | 37,640 | 13,675 |
| Boxed warning | Yes WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS • Methotrexate Injection can cause embr | Yes Only physicians experienced in cancer chemotherapy should use cytarabine injection. For induction therapy patients should be treated in a facility with laborato |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
Labeled signals distinctive to Methotrexate
- Pericarditis — n=6,863, PRR 30.0 Labeled adverse reaction
- Duodenal ulcer perforation — n=5,067, PRR 97.3 Labeled (related wording)
- Bone erosion — n=2,084, PRR 61.7 Labeled (related wording)
- Lymphoproliferative disorder — n=1,503, PRR 44.9 Labeled (related wording)
- Rheumatoid lung — n=451, PRR 37.7 Labeled (related wording)
Labeled signals distinctive to Cytarabine
- Secondary immunodeficiency — n=256, PRR 95.8 Labeled — boxed warning
- Abscess bacterial — n=73, PRR 90.1 Labeled (related wording)
- Cytarabine syndrome — n=39, PRR 374.2 Labeled adverse reaction
Common questions
Which has more reported side effects, Methotrexate or Cytarabine?
Methotrexate has 483,097 FAERS reports and Cytarabine 59,730. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (73% vs 97%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Methotrexate and Cytarabine share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Methotrexate or Cytarabine safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.