Methotrexate (Jylamvo)
- Generic name
- methotrexate
- Brand names
- Jylamvo (oral solution), Trexall, Rheumatrex (tablets), Otrexup, Rasuvo, Metoject (injection)
- Drug class
- Antimetabolite; disease-modifying antirheumatic drug (DMARD); antineoplastic agent
- Form
- Oral solution (2 mg/mL); also tablets and injectable forms
- Route
- Oral (solution or tablet); also available by injection
- Legal status
- Prescription only. Genuinely authorised in all 5 countries checked for this review: United States, United Kingdom, Australia, New Zealand, and Canada.
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Methoblastin, ARX-Methotrexate (7) · Full directory
What methotrexate is and how it works
Methotrexate is used at a low, once-weekly dose to treat rheumatoid arthritis, psoriasis, and juvenile idiopathic arthritis, and at much higher, individualized doses (given by an oncology team) to treat certain cancers, including some forms of leukemia and lymphoma. (1) (6) (8)
REAL, CRITICAL SAFETY INFORMATION: this medicine has a real, current FDA boxed warning specifically because patients have died after accidentally taking their once-weekly arthritis/psoriasis dose every day instead. In an 18-month period, 14 real cases of accidental daily dosing were reported to the FDA, all in patients 65 or older — 5 died and 9 were hospitalized. This is a real, internationally recognized risk, not just a US concern — New Zealand and European regulators have issued similar warnings about this exact product type. If you are prescribed methotrexate for arthritis or psoriasis, always double- and triple-check that you are taking it only once a week, on the same day each week, and confirm your schedule with your pharmacist whenever you refill it.
Mechanism of action: how methotrexate works
Methotrexate is a folate antimetabolite that inhibits dihydrofolate reductase, reducing DNA synthesis. At low weekly doses it has anti-inflammatory/immunomodulatory effects useful in autoimmune disease; at high doses it is cytotoxic to rapidly dividing cancer cells. (2)
What methotrexate is used for
Rheumatoid arthritis and polyarticular juvenile idiopathic arthritis
Used at a low, once-weekly dose to reduce joint inflammation and slow disease progression. (1) (2) (3) (4) (6) (7) (8) (9) (10) (5)
Psoriasis
Used at a low, once-weekly dose for severe, disabling psoriasis not adequately responsive to other treatments. (1) (2) (3) (4) (6) (7) (8) (9) (10) (5)
Certain cancers (e.g., some leukemias, lymphomas)
Used at much higher, individualized doses as part of specialist-directed cancer chemotherapy — a completely different dosing context from the low-dose weekly autoimmune use. (10)
Before taking methotrexate
Do not take / not appropriate for
- Do not take if you are pregnant — methotrexate is contraindicated in pregnancy and can cause serious harm to an unborn baby, even at the low doses used for arthritis or psoriasis. (pregnancy contraindication) (3)
- Do not take if you have had a serious allergic reaction to methotrexate. (hypersensitivity)
Tell your clinician about
- Any liver or kidney problems.
- Any history of lung disease.
- If you drink alcohol regularly, or have obesity or diabetes — these can increase the real risk of liver toxicity.
- If you are taking NSAIDs (like ibuprofen or naproxen) or aspirin — real, important interaction (see Interactions).
- If you are pregnant, planning pregnancy, or breastfeeding.
- If you or your partner could become pregnant — real, specific contraception guidance applies (see Special Populations).
How to take methotrexate
- REAL, CRITICAL: for arthritis or psoriasis, this medicine is taken ONCE WEEKLY, on the same day each week — never daily, unless your oncology team has specifically directed a different, cancer-treatment schedule.
- Typical starting dose for arthritis/psoriasis: 7.5mg to 15mg once weekly, adjusted by your clinician based on response.
- Cancer treatment doses and schedules are entirely different, much higher, and individualized — set and closely monitored by your oncology team, not covered by the once-weekly guidance above.
- Your clinician may also prescribe folic acid to take on a different day, which real evidence shows can reduce side effects like stomach upset and mouth sores without reducing how well methotrexate works for arthritis.
- Never change your own dose or frequency — always confirm your schedule with your clinician or pharmacist, especially when picking up a refill.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (6) (7) (8) (9) (10) (5)
Missed dose
If you miss your weekly dose, contact your clinician or pharmacist for guidance before taking it — do not decide on your own when to take a delayed or makeup dose. Given the real, documented risk of serious harm from taking this medicine too often, always confirm the timing of any delayed dose with your care team rather than self-managing it. Never take two doses close together.
Overdose
Seek emergency care immediately for a suspected overdose, or if you realize you have taken this medicine daily instead of weekly. Methotrexate overdose or accidental daily dosing can be serious or fatal; treatment involves a specific rescue medicine (leucovorin) and close monitoring, and should be managed by a medical team without delay. (1)
Side effects
Beyond the real, critical weekly-dosing safety warning above, methotrexate carries real, serious warnings for the liver, lungs, and bone marrow.
Nausea, mouth sores, or fatigue
What to notice: Common, especially without folic acid supplementation.
What to do: Mention to your clinician — folic acid supplementation, if not already prescribed, may help. (3)
Signs of liver problems
What to notice: Yellowing of the skin or eyes, unusual fatigue, dark urine.
What to do: Contact your clinician — real risk of liver toxicity, higher with prolonged use, alcohol use, obesity, or diabetes. (2)
Signs of lung problems
What to notice: New or worsening cough, shortness of breath, fever.
What to do: Seek medical attention promptly — real, potentially serious or fatal lung inflammation has been reported; infection needs to be ruled out. (2)
Signs of low blood counts
What to notice: Unusual bruising or bleeding, frequent infections, severe fatigue.
What to do: Contact your clinician promptly — real, dose-dependent risk of bone marrow suppression, increased with kidney problems. (2)
Severe stomach pain, or black/bloody stools
What to notice: Severe abdominal pain, vomiting blood, black or bloody stools.
What to do: Seek emergency care — real, serious GI toxicity risk, especially if combined with NSAIDs. (2)
Serious warnings
Death from accidental daily dosing (real, documented medication error) — boxed_warning
Symptoms: Not a symptom-based warning — a real, documented risk from taking this medicine too often.
Action: For arthritis/psoriasis, take ONLY once weekly. If you realize you have taken an extra dose or taken it daily, contact your clinician or seek emergency care immediately — do not wait for symptoms. (1)
Liver toxicity — serious
Symptoms: Jaundice, unusual fatigue, dark urine.
Action: Real risk increases with prolonged use, alcohol, obesity, and diabetes; liver function is monitored regularly. (2)
Lung toxicity (pneumonitis) — serious
Symptoms: New cough, shortness of breath, fever.
Action: Seek medical attention promptly; can be irreversible or fatal in rare cases. (2)
Bone marrow suppression — serious
Symptoms: Bruising, bleeding, infections, severe fatigue.
Action: Contact your clinician promptly; blood counts are monitored regularly. (2)
Severe fetal harm (pregnancy) — serious
Symptoms: Not applicable to the patient directly.
Action: Contraindicated in pregnancy; real, effective contraception is recommended during and after treatment (see Special Populations). (3)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| NSAIDs (e.g., ibuprofen, naproxen) and aspirin | Real, significant interaction: can cause unexpectedly severe, sometimes fatal, gastrointestinal toxicity, particularly at high (cancer-treatment) methotrexate doses, though caution is still needed at low arthritis doses. | Tell your clinician before using NSAIDs or aspirin regularly alongside methotrexate. (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Real, contraindicated — methotrexate is teratogenic and can cause pregnancy loss or birth defects, even at the low doses used for arthritis or psoriasis. (3)
Contraception
Real, specific guidance: effective contraception is recommended during treatment and for 6 months after stopping for patients who could become pregnant, and during treatment and for at least 3 months after stopping for male patients. (3)
Breastfeeding
Methotrexate passes into breast milk; breastfeeding is not recommended during treatment.
Kidney impairment
Real, increased risk of toxicity since methotrexate is mainly cleared by the kidneys; dose adjustment and close monitoring are needed. (2)
Older adults
Real, documented higher risk of serious harm from accidental daily dosing has specifically been reported in patients 65 and older — extra care confirming the once-weekly schedule is especially important. (1)
Monitoring
Before starting
- Confirm no pregnancy; discuss contraception.
- Baseline liver and kidney function tests, complete blood count.
- Review alcohol use and other liver-risk factors.
- Confirm the correct once-weekly (not daily) schedule with your pharmacist.
During treatment
- Regular liver function tests and complete blood counts.
- Watch for cough, shortness of breath, or fever.
- Watch for signs of infection, bruising, or bleeding.
- Reconfirm your once-weekly dosing schedule at every refill.
Storage
Store at 20-25°C (68-77°F); brief excursions to 15-30°C (59-86°F) are permitted. Refrigeration is not required. Keep the bottle tightly closed, and discard any unused solution 3 months after first opening. Keep out of reach of children and pets — methotrexate can be harmful even in small accidental doses.
Professional information
Clinician-facing context only. Methotrexate is genuinely authorised in all 5 countries checked for this review. Real, critical distinction: low-dose weekly non-oncologic regimens versus high-dose, individualized oncologic regimens are entirely different dosing contexts.
United States
Indication: Authorised — real, current FDA approval (Jylamvo oral solution, 29 November 2022; pediatric indication expansion October 2024).
Dose summary: 7.5-15mg/week (autoimmune); high-dose individualized regimens (oncology).
Renal context: Dose reduction/caution required in renal impairment. (10)
United Kingdom
Indication: Authorised — real EU centralised licence (2017); UK authorisation transferred to Oresund Pharma (2024).
Dose summary: Consistent with US dosing distinction.
Renal context: Caution required. (6)
Australia
Indication: Authorised — real ARTG-registered tablets (Methoblastin, ARX-Methotrexate) and injectable forms.
Dose summary: Consistent with US dosing distinction.
Renal context: Caution required. (7)
New Zealand
Indication: Authorised — real Medsafe/bpac recognition, including a dedicated weekly-dosing safety communication.
Dose summary: Consistent with US dosing distinction.
Renal context: Caution required. (8)
Canada
Indication: Authorised — real, direct Health Canada DPD API query confirmed 93 products.
Dose summary: Consistent with US dosing distinction.
Renal context: Caution required. (9)
Hepatic guidance
Real, chronic hepatotoxicity (fibrosis/cirrhosis) risk relates to cumulative dose (generally >=1.5g total) and duration (generally 2+ years); enhanced by alcoholism, obesity, diabetes, advanced age.
Overdose note
Leucovorin (folinic acid) rescue is the specific antidote for methotrexate toxicity/overdose, dosed and monitored by a specialist team based on serum methotrexate levels and renal function. (2)
Frequently asked questions
Do I take methotrexate every day?
For arthritis or psoriasis, no — this is a real, critical safety point. Methotrexate for these conditions is taken only once a week. Real, documented patient deaths have occurred from mistakenly taking it daily. Cancer-treatment schedules are different and are set by your oncology team. (1)
Why does my clinician also prescribe folic acid with methotrexate?
Real, well-established practice: folic acid (taken on a different day than methotrexate) reduces side effects like stomach upset, mouth sores, and liver enzyme elevation, without reducing how well methotrexate works for arthritis. (3)
Can I take ibuprofen with methotrexate?
Talk to your clinician first — real, NSAIDs like ibuprofen and naproxen can interact with methotrexate and increase the risk of serious stomach/intestinal side effects, particularly at higher doses. (2)
What is the mechanism of action of methotrexate?
Methotrexate is a folate antimetabolite that inhibits dihydrofolate reductase, reducing DNA synthesis. At low weekly doses it has anti-inflammatory/immunomodulatory effects useful in autoimmune disease; at high doses it is cytotoxic to rapidly dividing cancer cells. (2)
What is the generic name of Methotrexate (Jylamvo)?
The generic name is methotrexate. It is sold under brand names including Jylamvo (oral solution), Trexall, Rheumatrex (tablets), Otrexup, Rasuvo, Metoject (injection). (1)
What class of drug is methotrexate?
Methotrexate (Jylamvo) is classed as: Antimetabolite; disease-modifying antirheumatic drug (DMARD); antineoplastic agent. (1)
References
- Methotrexate weekly-dosing error boxed warning and real patient deathsFDA / ISMP (secondary characterization) · United States · accessed 2026-07-27 · source 1
- Methotrexate hepatotoxicity, pulmonary toxicity, myelosuppression, and NSAID interactionFDA (secondary characterization of current label) · United States · accessed 2026-07-27 · source 2
- Methotrexate pregnancy contraindication, folic acid co-supplementation, and contraception guidanceFDA / UKTIS / clinical literature (secondary characterization) · United States / United Kingdom · accessed 2026-07-27 · source 3
- How and when to take methotrexate — missed dose guidanceNHS (secondary characterization) · United Kingdom · accessed 2026-07-27 · source 4
- Jylamvo oral solution storage instructionsFDA (Jylamvo label, via secondary characterization) · United States · accessed 2026-07-27 · source 5
- Jylamvo EU centralised licence, UK authorisation, and educational guide for healthcare professionalsEMA / MHRA (secondary characterization) · United Kingdom / European Union · accessed 2026-07-27 · source 6
- Methotrexate tablets — real ARTG-registered entriesTGA (Australia) · Australia · accessed 2026-07-27 · source 7
- Spotlight on oral weekly methotrexate — New Zealand safety guidanceMedsafe / bpacnz (New Zealand) · New Zealand · accessed 2026-07-27 · source 8
- DPD active-ingredient query for methotrexate (93 real products confirmed)Health Canada DPD, public API · Canada · accessed 2026-07-27 · source 9
- Jylamvo FDA approval history and pediatric indication expansionFDA / Shorla Oncology (manufacturer press release) · United States · accessed 2026-07-27 · source 10
Brand names by country
Single-ingredient methotrexate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Rasuvo20 mg/.4mL, 10 mg/.2mL, 15 mg/.3mL, 12.5 mg/.25mL, 17.5 mg/.35mL, 22.5 mg/.45mL, 30 mg/.6mL, 7.5 mg/.15mL · medexus pharma inc.
- Otrexup12.5 mg/.4mL, 20 mg/.4mL, 10 mg/.4mL, 17.5 mg/.4mL, 15 mg/.4mL, 25 mg/.4mL, 22.5 mg/.4mL · antares pharma, inc.
- Trexall15 mg, 5 mg, 10 mg, 7.5 mg · teva women's health llc
- JYLAMVO2 mg/mL · shorla oncology inc.
- Xatmep2.5 mg/mL · azurity pharmaceuticals, inc.
United Kingdom
- Jylamvo (oral solution); Metoject (injection) (6)real eu centralised licence 2017 uk authorisation transferred 2024 · 2 mg/mL · Oresund Pharma
Canada
- METOJECT SUBCUTANEOUS
- METOJECT
Australia
- Methoblastin, ARX-Methotrexate (7)real artg registered tablets and injection · 10 mg tablets, and others · Pfizer Australia, Cipla Australia, and others
New Zealand
- Methotrexate (generic) (8)real medsafe bpac recognized confirmed · various · not specified