METHOTREXATE SHOULD BE USED ONLY BY PHYSICIANS WHOSE KNOWLEDGE AND EXPERIENCE INCLUDE THE USE OF ANTIMETABOLITE THERAPY.
BECAUSE OF THE POSSIBILITY OF SERIOUS TOXIC REACTIONS (WHICH CAN BE FATAL):
- METHOTREXATE SHOULD BE USED ONLY IN LIFE THREATENING NEOPLASTIC DISEASES, OR IN PATIENTS WITH PSORIASIS OR RHEUMATOID ARTHRITIS WITH SEVERE, RECALCITRANT, DISABLING DISEASE WHICH IS NOT ADEQUATELY RESPONSIVE TO OTHER FORMS OF THERAPY.
- DEATHS HAVE BEEN REPORTED WITH THE USE OF METHOTREXATE IN THE TREATMENT OF MALIGNANCY, PSORIASIS, AND RHEUMATOID ARTHRITIS.
- PATIENTS SHOULD BE CLOSELY MONITORED FOR BONE MARROW, LIVER, LUNG AND KIDNEY TOXICITIES. (See PRECAUTIONS.)
- PATIENTS SHOULD BE INFORMED BY THEIR PHYSICIAN OF THE RISKS INVOLVED AND BE UNDER A PHYSICIAN'S CARE THROUGHOUT THERAPY.
- Methotrexate has been reported to cause fetal death and/or congenital anomalies. Therefore, it is not recommended for women of childbearing potential unless there is clear medical evidence that the benefits can be expected to outweigh the considered risks. Pregnant women with psoriasis or rheumatoid arthritis should not receive methotrexate. (See CONTRAINDICATIONS.)
- Methotrexate elimination is reduced in patients with impaired renal function, ascites, or plural effusions. Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of methotrexate administration.
- Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). (See PRECAUTIONS: Drug Interactions.)
- Methotrexate causes hepatotoxicity, fibrosis, and cirrhosis, but generally only after prolonged use. Acutely, liver enzyme elevations are frequently seen. These are usually transient and asymptomatic, and also do not appear predictive of subsequent hepatic disease. Liver biopsy after sustained use often shows histologic changes, and fibrosis and cirrhosis have been reported; these latter lesions may not be preceded by symptoms or abnormal liver function tests in the psoriasis population. For this reason, periodic liver biopsies are usually recommended for psoriatic patients who are under long-term treatment. Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the rheumatoid arthritis population. (See PRECAUTIONS; Organ System Toxicity: Hepatic)
- Methotrexate-induced lung disease is a potentially dangerous lesion, which may occur acutely at any time during therapy and which has been reported at doses as low as 7.5 mg/week. It is not always fully reversible. Pulmonary symptoms (especially a dry, nonproductive cough) may require interruption of treatment and careful investigation.
- Diarrhea and ulcerative stomatitis require interruption of therapy; otherwise, hemorrhagic enteritis and death from intestinal perforation may occur.
- Malignant lymphomas, which may regress following withdrawal of methotrexate, may occur in patients receiving low-dose methotrexate and, thus, may not require cytotoxic treatment. Discontinue methotrexate first and, if the lymphoma does not regress, appropriate treatment should be instituted.
- Like other cytoxic drugs, methotrexate may induce “tumor lysis syndrome” in patients with rapidly growing tumors. Appropriate supportive and pharmacologic measures may prevent or alleviate this complication.
- Severe, occasionally fatal, skin reactions have been reported following single or multiple doses of methotrexate. Reactions have occurred within days of oral, intramuscular, intravenous, or intrathecal methotrexate administration. Recovery has been reported with discontinuation of therapy. (See PRECAUTIONS; Organ System Toxicity: Skin.)
- Potentially fatal opportunistic infections, especially Pneumocystis carinii pneumonia, may occur with methotrexate therapy.
- Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.
METHOTREXATE Tablets USP, 2.5 mg
Each tablet contains methotrexate sodium equivalent to:
Methotrexate. .. .. .. .. . 2.5 mg
Methotrexate is an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis.
Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole.
Methotrexate is used in maintenance therapy in combination with other chemotherapeutic agents.
Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma) and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin’s lymphomas.
Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses.
Rheumatoid Arthritis including Polyarticular-Course Juvenile Rheumatoid Arthritis
Methotrexate is indicated in the management of selected adults with severe, active, rheumatoid arthritis (ACR criteria), or children with active polyarticular-course juvenile rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose nonsteroidal anti-inflammatory agents (NSAIDs).
Aspirin, NSAIDs, and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored. (See PRECAUTIONS, Drug Interactions.) Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.
Media Articles Related to Methotrexate
New Injection Device Approved for Methotrexate
Source: MedPage Today Dermatology [2013.10.14]
(MedPage Today) -- The FDA has approved a self-injection device for the subcutaneous administration of methotrexate, manufacturer Antares Pharma announced today.
Adalimumab plus methotrexate effective for rheumatoid arthritis
Source: The Doctors Lounge - Rheumatology
Adalimumab and methotrexate is about five times more effective than methotrexate alone, according to a new systematic review of studies.
New Anti-IL-6 Biologic Succeeds in RA
Source: MedPage Today Rheumatology [2013.11.22]
(MedPage Today) -- The investigational subcutaneous interleukin (IL)-6 blocker sarilumab plus methotrexate was effective in reducing the signs and symptoms of rheumatoid arthritis in a phase III trial, the drug's makers announced Friday.
Medications Used To Treat Rheumatoid Arthritis May Affect Abortion Rate In Women
Source: Abortion News From Medical News Today [2013.04.16]
A new study published in the American College of Rheumatology (ACR) journal, Arthritis Care & Research, reveals that women with rheumatoid arthritis (RA) who were on methotrexate (MTX), a drug commonly used to reduce inflammation caused by RA, had lower rates of induced abortions compared to women with RA who were not exposed to the medication.
Published Studies Related to Methotrexate
Phase II trial of methotrexate in myasthenia gravis. 
Prednisone is a frequently used treatment for myasthenia gravis (MG) but it has
numerous side effects... sites and 2 Canadian sites are participating,
with 48 screened cases, 42 enrolled, with 19 still active in the study.
Clinical evaluation of the efficacy of the P2X7 purinergic receptor antagonist
AZD9056 on the signs and symptoms of rheumatoid arthritis in patients with active
disease despite treatment with methotrexate or sulphasalazine. 
primary outcome... CONCLUSIONS: AZD9056 does not have significant efficacy in the treatment of RA,
Concomitant iguratimod therapy in patients with active rheumatoid arthritis
despite stable doses of methotrexate: a randomized, double-blind,
placebo-controlled trial. 
stable background methotrexate (MTX) alone... CONCLUSION: The study results
A long-term follow-up study of methotrexate in juvenile localized scleroderma
followed up for a prolonged period... CONCLUSIONS: Long-term MTX therapy is beneficial and well tolerated for JLS.
Methotrexate vs placebo in early tubal ectopic pregnancy: a multi- centre
double-blind randomised trial. 
BACKGROUND: In the 21st century, tubal ectopic pregnancies (EPs) are diagnosed
earlier in their natural history due to transvaginal ultrasound technology. More
women are haemodynamically stable and therefore can be offered non-invasive
outpatient management with systemic Methotrexate (MTX)... DISCUSSION: This trial will clarify the actual effectiveness of MTX in
haemodynamically stable women with an early tubal EPs and rising or plateauing
Clinical Trials Related to Methotrexate
Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone [Completed]
The purpose of this study is to determine if a combination of methotrexate and minocycline
works better than methotrexate alone in early Rheumatoid Arthritis
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis [Completed]
The purpose of this clinical research study is to learn if Abatacept in combination with
Methotrexate and Infliximab demonstrate a greater reduction in disease activity over
Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis [Active, not recruiting]
To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change
and clinical disease activity in subjects with early RA over 12 months.
A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-Naive [Active, not recruiting]
The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in
combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis
subjects who have not been previously treated with methotrexate.
Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-NaÃ¯ve Disease (RESPOND) (Study P04422AM1)(COMPLETED) [Completed]
Reports of Suspected Methotrexate Side Effects
Dyspnoea (109), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 18 ratings/reviews, Methotrexate has an overall score of 7.22. The effectiveness score is 8.56 and the side effect score is 6.78. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Methotrexate review by 64 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || Rheumatoid Arthritis|
|Dosage & duration:|| || 20 mg. taken 1 x week for the period of 2 years to present|
|Other conditions:|| || none|
|Other drugs taken:|| || Remicade|
|Benefits:|| || The combination of weekly 20mg. Methotrexate with an infusion (at the doctor's office) of Remicade has almost completely controlled my rheumatoid arthritis.
I have had no further joint damage, and the initial symptoms of extreme fatigue and pain in the small joints of my hands, wrists, feet and ankles has abated.|
|Side effects:|| || None that I am aware of|
|Comments:|| || I was diagnosed with rheumatoid arthritis about two years ago and began treatment with a combination of Remicade (infused once every eight weeks over a period of about 2 hours in my doctor's office) and Methotrexate 20 mg. once a week. I take 8 tablets every Friday, 2.r mg. each. I have had no negative side effects from either medication. |
Methotrexate review by 39 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || Rhematory Arthritis|
|Dosage & duration:|| || 1 cc (dosage frequency: weekly injection) for the period of 2 years|
|Other conditions:|| || Uticaria|
|Other drugs taken:|| || None|
|Benefits:|| || This drug definitely helped control flares and joint stiffness. It also helped defeat the incredible amount of hives. Hives were completely controlled.|
|Side effects:|| || Unfortunately, there were many side effects such as diarrhea, nausea, occasional vomiting, extreme fatigue, foggy mind. Bruising at the injection site was also very common.|
|Comments:|| || One injection every week.|
Methotrexate review by 58 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || psoraitic arthritis|
|Dosage & duration:|| || 6 tabs taken daily for the period of 4 years|
|Other conditions:|| || psoriasis|
|Other drugs taken:|| || none|
|Benefits:|| || the treatment masked the psoriasis and what was considered arthritis|
|Side effects:|| || increasing all over body pain|
|Comments:|| || I started with 4 tabs and increased to 6 as the all over body pain increased and then they were going to put me on prednisone. I opted to turn to homeopathic treatment and weaned off the methotrexate. The all over body pain went completely away but the psoriasis was exacerbated. I'd rather have that than not be able to walk or move.|
Page last updated: 2013-11-22