Prescription medication · Disease-Modifying Antirheumatic Drug (DMARD)
methotrexate
Also sold as Trexall, Otrexup. Methotrexate can treat acute lymphoblastic leukemia, a type of cancer, in adults and children.
Data updated 2026-05-15
- 410,053
- FDA reportsHeavily reported
- 38
- InteractionsSeveral interactions
- 99% less
- Generic vs brandHuge savings
- In shortage
- FDA status
What the data shows
methotrexate (Trexall) is a prescription Disease-Modifying Antirheumatic Drug (DMARD), one of the most-reported medications in the FDA FAERS database (410,053 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
methotrexate (Trexall) is a prescription Disease-Modifying Antirheumatic Drug (DMARD). Methotrexate can treat acute lymphoblastic leukemia, a type of cancer, in adults and children.
Methotrexate is a drug that can treat certain cancers, rheumatoid arthritis, psoriasis, and other conditions. It works by slowing the growth of cells in the body.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
methotrexate is currently listed as in shortage by the FDA. Affected manufacturer: Fresenius Kabi USA, LLC. Status: Available.
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$470.62/unit
Generic Price
$0.16/unit
Generic Savings
99%
Generic Available
Yes (20 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: METHOTREXATE 2.5 MG TABLET
Same CMS presentation as the headline generic unit price above (3 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -9.1% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| February 21, 2024 | $0.1919/EA | - | 1 |
| October 23, 2024 | $0.1741/EA | -9.3% | 1 |
| December 18, 2024 | $0.1583/EA | -9.1% | 20 |
What it does
Methotrexate can treat acute lymphoblastic leukemia, a type of cancer, in adults and children.
Common side effects
Mouth sores, Nausea, Abdominal pain
Key warnings
Methotrexate can cause serious harm to an unborn baby, including death.
The sections below are summarized in plain English from methotrexate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Methotrexate blocks an enzyme called dihydrofolate reductase. This enzyme is needed for cells to grow and multiply. By blocking this enzyme, methotrexate slows down the growth of cells, especially cancer cells and cells that cause inflammation in arthritis and psoriasis.
Side Effects (from patient reports)
Based on 410,053 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for methotrexate, by number of reports
- Rheumatoid Arthritis
Rheumatoid Arthritis
38,053 reports
- Arthralgia
Arthralgia
36,283 reports
- Pain
Pain
35,413 reports
- Fatigue
Fatigue
29,061 reports
- Nausea
Nausea
24,009 reports
- Joint Swelling
Joint Swelling
22,294 reports
- Headache
Headache
20,815 reports
- Rash
Rash
19,771 reports
- Condition Aggravated
Condition Aggravated
19,607 reports
- Diarrhoea
Diarrhoea
18,210 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for methotrexate each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where methotrexate sits
methotrexate has more FDA adverse-event reports than 99% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is methotrexate; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 410,053 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1999–2025.
Total Reports
410,053
Reports Mentioning Death
32,502
7.9% of reports — not proof of cause
Hospitalization Reports
115,535
Top Indication
Rheumatoid Arthritis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | RHEUMATOID ARTHRITIS | 38,053 |
| 3 | ARTHRALGIA | 36,283 |
| 4 | PAIN | 35,413 |
| 6 | FATIGUE | 29,061 |
| 7 | NAUSEA | 24,009 |
| 8 | JOINT SWELLING | 22,294 |
| 9 | HEADACHE | 20,815 |
| 10 | RASH | 19,771 |
| 11 | CONDITION AGGRAVATED | 19,607 |
| 13 | DIARRHOEA | 18,210 |
| 14 | PAIN IN EXTREMITY | 17,887 |
| 15 | PYREXIA | 16,928 |
| 16 | PNEUMONIA | 16,118 |
| 17 | MALAISE | 15,153 |
| 18 | VOMITING | 15,002 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Methotrexate can cause serious harm to an unborn baby, including death. If you are pregnant, you should not take this medicine for non-cancer conditions. If you are taking it for cancer, talk to your doctor about the risks. This medicine can also cause severe allergic reactions and other serious side effects that can be life-threatening. Contact your doctor immediately if you experience any signs of infection, lung problems, or kidney problems.
Known Drug Interactions
Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Celecoxib has no effect on methotrexate pharmacokinetics. Intervention: During concomitant use of celecoxib and methotrexate, monitor patients for methotrexate toxicity.
Mechanism: Celecoxib can make methotrexate more harmful to your blood and kidneys. This happens even though the amount of methotrexate in your blood stays the same.
Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Mechanism: Diflunisal can prevent your kidneys from clearing methotrexate out of your system, which can lead to toxic levels of the drug in your blood. This makes the side effects of methotrexate much more dangerous.
Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Intervention: During concomitant use of indomethacin capsules and methotrexate, monitor patients for methotrexate toxicity.
Mechanism: Indomethacin can cause methotrexate to build up to dangerous levels in your body, which may harm your kidneys or blood cells.
Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Intervention: During concomitant use of mefenamic acid and methotrexate, monitor patients for methotrexate toxicity.
Mechanism: This pain medicine can prevent your body from clearing out methotrexate, which can lead to toxic levels in your system.
Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Intervention: During concomitant use of meloxicam and methotrexate, monitor patients for methotrexate toxicity.
Mechanism: Meloxicam can cause methotrexate to build up in your body to unsafe levels. This can lead to serious issues like low blood cell counts and kidney damage.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can methotrexate cure my condition?
How long does it take for methotrexate to work?
Can I drink alcohol while taking methotrexate?
What tests will I need while taking methotrexate?
Can methotrexate affect my ability to have children?
What should I do if I get an infection while taking methotrexate?
Can I take other medicines with methotrexate?
What if I have trouble swallowing the tablet?
Is there a risk of cancer with this medicine?
What should I do if I experience side effects?
What are the common side effects of methotrexate?
Does methotrexate interact with other medications?
What drug class is methotrexate?
Is there a generic version of methotrexate?
What pregnancy or breastfeeding source fields are listed for methotrexate?
Is methotrexate currently in shortage?
Related Medications in Disease-Modifying Antirheumatic Drug (DMARD)
Other drugs grouped near methotrexate - same-class peers and common alternatives.
abatacept
Orencia
Orencia is a medicine that helps to reduce inflammation.
Compare with methotrexate →
acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
Compare with methotrexate →
acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
Compare with methotrexate →
acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
Compare with methotrexate →
adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
Compare with methotrexate →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for methotrexate: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 410,053.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.93%.
- saxagliptin Δ 0.03 pts · 8,141 reports · DPP-4 Inhibitor 7.96%death share
- mirabegron Δ 0.04 pts · 36,931 reports · Beta-3 Agonist (Overactive Bladder) 7.89%death share
- insulin glulisine Δ 0.07 pts · 9,944 reports · Rapid-Acting Insulin 7.99%death share
- pregabalin Δ 0.09 pts · 264,092 reports · Anticonvulsant / Nerve Pain Agent 8.01%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on methotrexate
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What the FDA Data Shows for methotrexate
The FDA label for methotrexate (sold under brand names such as Trexall, Otrexup) classifies it as a prescription-only medication in the Disease-Modifying Antirheumatic Drug (DMARD) class. Methotrexate can treat acute lymphoblastic leukemia, a type of cancer, in adults and children. Official labeling lists 4 commonly reported side effects, including Mouth sores, Nausea, Abdominal pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 410,053 voluntary reports. The database also lists 38 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.16 versus $470.62 for the brand - a 99% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: June 4, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages