Does methotrexate expire?
The printed date covers the sealed pack. Once methotrexate is opened, mixed or diluted, its label sets a second and usually much shorter limit — quoted below, per product.
Shortest limit on any methotrexate label: 4 hours
“Diluted product should be used within 4 hours when stored at room temperature (20°C to 25°C) or 24 hours under refrigeration (2°C to 8°C).”
That applies to the product it is printed on, not to every form of methotrexate — check which one you have against the list below.
What the labels say
“Diluted product should be used within 4 hours when stored at room temperature (20°C to 25°C) or 24 hours under refrigeration (2°C to 8°C).”
On the label for Methotrexate · DailyMed
“Diluted product should be used within 4 hours when stored at room temperature (20°C to 25°C) or 24 hours when stored under refrigeration (2°C to 8°C).”
On the label for Methotrexate · DailyMed
“After first puncture, store multiple-dose vials at 2°C to 8°C, and use within 30 days.”
On the label for Methotrexate · DailyMed
“If stored at room temperature, discard after 60 days.”
On the label for Xatmep · DailyMed
“After first opening, discard any unused medicine after 3 months.”
On the label for JYLAMVO · DailyMed
How the label says to keep methotrexate
Storage is the other half of the question: the stability behind any date assumes these conditions, and a medicine kept outside them ages faster than the calendar says.
- “16 HOW SUPPLIED/STORAGE AND HANDLING Methotrexate tablets USP, 2.”
- “Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].”
- “16 HOW SUPPLIED/STORAGE AND HANDLING Methotrexate Tablets USP, 2.”
- “Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature].”
- “and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].”
- “Protect from light.”
- “After first puncture, store multiple-dose vials at 2°C to 8°C, and use within 30 days.”
- “16 HOW SUPPLIED/STORAGE AND HANDLING Methotrexate tablets, USP are yellow, round, uncoated tablets, with debossing "L2" on one side and scoring on other side.”
Frequently asked questions
Does methotrexate expire?
Two different clocks apply and only one of them is the printed date. The date on a sealed pack is the manufacturer's guarantee for the unopened product. Once it is opened, mixed or diluted, the label imposes its own limit — as tight as 4 hours on some methotrexate products, and that is the number quoted on this page.
Can I still use methotrexate after the date on the box?
This page cannot tell you that, and nor can any page. The FDA's own shelf-life programme found 88% of tested lots stayed within specification at least a year past expiry — and concluded in the same breath that lot-to-lot variation means this can only be confirmed by testing each lot. What you can check at home is the in-use limit above and whether the product has been stored as the label requires. Ask a pharmacist about a specific pack; they will also dispose of what you no longer need.
Why do different methotrexate products have different limits?
Because they are different formulations. A suspension that gets mixed with water, a pen that gets carried at room temperature, and a sealed tablet do not behave alike, so each manufacturer's label sets its own limit and each is shown here with the product it belongs to. We never merge them into one number for the molecule.
More on methotrexate
Quoted from FDA labels for reference, not medical advice, and not a suggestion to use anything past its limit. If you are unsure whether a pack is still good, a pharmacist can tell you and can dispose of it safely.