Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] • Myelosuppression [see Warnings and Precautions ( 5.3 )] • Gastrointestinal Toxicity [see Warnings and Precautions ( 5.4 )] • Hepatotoxicity [see Warnings and Precautions ( 5.5 )] • Pulmonary Toxicity [see Warnings and Precautions ( 5.6 )] • Dermatologic Reactions [see Warnings and Precautions ( 5.7 )] • Renal Toxicity [see Warnings and Precautions ( 5.8 )] • Serious Infections [see Warnings and Precautions ( 5.11 )] • Neurotoxicity [see Warnings and Precautions ( 5.12 )] • Secondary Malignancies [see Warnings and Precautions ( 5.13 )] • Tumor Lysis Syndrome [see Warnings and Precautions ( 5.14 )] • Increased Risk of Adverse Reactions Due to Third-Space Accumulation [see Warnings and Precautions ( 5.17 )] Common adverse reactions include ulcerative stomatitis, leukopenia, nausea, abdominal distress.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Elite Laboratories, Inc .
at 1-888-852-6657 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials and other studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Common adverse reactions were: ulcerative stomatitis, leukopenia, nausea, and abdominal distress.
Other clinically relevant adverse reactions were infection, malaise, fatigue, chills, fever, and dizziness.
Rheumatoid Arthritis The most common adverse reactions of methotrexate that exceeded the rate of placebo in 12- to 18-week double-blind studies in patients (n=128) with rheumatoid arthritis are listed below.
Patients received methotrexate 7.5 to 15 mg orally once weekly.
Most patients received concomitant nonsteroidal anti-inflammatory drugs (NSAIDs) and some also received corticosteroids.
Hepatic histology was not examined in these short-term studies.
5 WARNINGS AND PRECAUTIONS • Serious Infections : Monitor patients for infection during and after treatment with Methotrexate Tablets.
Withhold or discontinue Methotrexate Tablets for serious infections as appropriate.
( 5.11 ) • Neurotoxicity : Monitor patients for neurotoxicity and withhold or discontinue Methotrexate Tablets as appropriate.
( 5.12 ) • Secondary Malignancies : Can occur with methotrexate.
( 5.13 ) • Tumor Lysis Syndrome : Institute appropriate prophylactic measures in patients at risk for tumor lysis syndrome prior to initiation of Methotrexate Tablets.
Like all medications, Methotrexate Sodium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: