methotrexate
Brand names: Trexall, Otrexup
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.
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
100%
Generic Available
Yes (20 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
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.
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.
How to Take It
Take methotrexate exactly as your doctor tells you. It is important to take the correct dose to avoid serious problems. For leukemia, you may take it once a week. For other conditions, you may take it one to four times per week. Your doctor may adjust your dose based on how you respond to the medicine.
Pregnancy & Breastfeeding
Methotrexate can cause birth defects or fetal death if taken during pregnancy for non-cancer conditions. If you are pregnant or plan to become pregnant, talk to your doctor. Do not breastfeed while taking methotrexate, as it can pass into breast milk and harm your baby.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store methotrexate tablets at room temperature, away from heat and moisture.
Side Effects (from patient reports)
Based on 334,120 FDA adverse event reports.
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
Death-Related Reports
32,502
Hospitalization Reports
115,535
Top Indication
Rheumatoid Arthritis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 74,947 |
| 2 | RHEUMATOID ARTHRITIS | 38,053 |
| 3 | ARTHRALGIA | 36,283 |
| 4 | PAIN | 35,413 |
| 5 | OFF LABEL USE | 33,471 |
| 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 |
| 12 | DRUG INTOLERANCE | 19,524 |
| 13 | DIARRHOEA | 18,210 |
| 14 | PAIN IN EXTREMITY | 17,887 |
| 15 | PYREXIA | 16,928 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) 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.
What to do: Your doctor should monitor you closely for signs of methotrexate toxicity while you are taking both drugs.
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.
What to do: Be very careful when using these drugs together and make sure your doctor monitors your health and blood work closely.
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.
What to do: Your doctor should monitor you closely for signs of drug toxicity while you are using both medications.
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.
What to do: Your doctor should monitor you for signs of toxicity, such as kidney issues or changes in your blood cell counts.
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.
What to do: Your doctor should monitor you closely for signs of drug toxicity while you are taking both medications. You may need frequent blood tests to check your kidneys and blood.
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?
Is methotrexate safe during pregnancy?
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 →
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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 334,120 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 100% 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: June 4, 2024
Read our methodology — how this data is sourced, computed, and verified.
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