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METHOTREXATE SODIUM

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Methotrexate Sodium Adverse Events Reported to the FDA Over Time

How are Methotrexate Sodium adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Methotrexate Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Methotrexate Sodium is flagged as the suspect drug causing the adverse event.

Most Common Methotrexate Sodium Adverse Events Reported to the FDA

What are the most common Methotrexate Sodium adverse events reported to the FDA?

Pyrexia
1583 (1.5%)
Pneumonia
1309 (1.24%)
Pancytopenia
1006 (.96%)
Sepsis
974 (.93%)
Interstitial Lung Disease
902 (.86%)
Pneumocystis Jiroveci Pneumonia
901 (.86%)
Vomiting
887 (.84%)
Nausea
885 (.84%)
Diarrhoea
772 (.73%)
Neutropenia
755 (.72%)
Dyspnoea
696 (.66%)
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Anaemia
681 (.65%)
Respiratory Failure
668 (.63%)
Drug Ineffective
620 (.59%)
Renal Failure Acute
604 (.57%)
Febrile Neutropenia
588 (.56%)
Headache
585 (.56%)
Thrombocytopenia
583 (.55%)
Drug Interaction
578 (.55%)
Mucosal Inflammation
556 (.53%)
Abdominal Pain
540 (.51%)
Alanine Aminotransferase Increased
516 (.49%)
Multi-organ Failure
489 (.46%)
Pleural Effusion
487 (.46%)
Condition Aggravated
483 (.46%)
Renal Failure
473 (.45%)
Septic Shock
472 (.45%)
Hypotension
471 (.45%)
Aspartate Aminotransferase Increase...
463 (.44%)
Infection
463 (.44%)
Fatigue
457 (.43%)
Arthralgia
443 (.42%)
Asthenia
431 (.41%)
Malaise
416 (.4%)
Haemoglobin Decreased
414 (.39%)
White Blood Cell Count Decreased
409 (.39%)
Stomatitis
406 (.39%)
Bone Marrow Failure
404 (.38%)
Rheumatoid Arthritis
402 (.38%)
Platelet Count Decreased
400 (.38%)
General Physical Health Deteriorati...
396 (.38%)
Cough
395 (.38%)
Pain
367 (.35%)
Convulsion
366 (.35%)
Weight Decreased
363 (.34%)
Disseminated Intravascular Coagulat...
359 (.34%)
Leukopenia
359 (.34%)
Drug Toxicity
351 (.33%)
Rash
346 (.33%)
Hepatic Function Abnormal
337 (.32%)
Herpes Zoster
334 (.32%)
Dehydration
321 (.31%)
Pneumonitis
311 (.3%)
Acute Respiratory Distress Syndrome
308 (.29%)
Staphylococcal Infection
302 (.29%)
Oedema Peripheral
301 (.29%)
Hypertension
293 (.28%)
Drug Exposure During Pregnancy
283 (.27%)
Cardiac Failure
282 (.27%)
Renal Impairment
276 (.26%)
Dizziness
273 (.26%)
Urinary Tract Infection
273 (.26%)
Liver Disorder
270 (.26%)
Hepatic Enzyme Increased
258 (.25%)
Back Pain
255 (.24%)
Blood Bilirubin Increased
253 (.24%)
Pulmonary Fibrosis
253 (.24%)
Acute Myeloid Leukaemia
252 (.24%)
Cytomegalovirus Infection
252 (.24%)
Leukoencephalopathy
250 (.24%)
Ascites
249 (.24%)
Lung Disorder
248 (.24%)
Lymphoma
246 (.23%)
Chills
243 (.23%)
Myelodysplastic Syndrome
241 (.23%)
Cardiac Arrest
240 (.23%)
Cellulitis
239 (.23%)
Death
239 (.23%)
Pulmonary Embolism
237 (.23%)
Confusional State
235 (.22%)
Decreased Appetite
232 (.22%)
Anorexia
230 (.22%)
Encephalopathy
227 (.22%)
Neurotoxicity
227 (.22%)
Liver Function Test Abnormal
226 (.21%)
Erythema
225 (.21%)
Blood Creatinine Increased
224 (.21%)
Hypoxia
224 (.21%)
Tachycardia
221 (.21%)
Blood Lactate Dehydrogenase Increas...
219 (.21%)
Pulmonary Tuberculosis
218 (.21%)
Fall
214 (.2%)
Hepatic Failure
214 (.2%)
Lymphadenopathy
214 (.2%)
C-reactive Protein Increased
213 (.2%)
Respiratory Distress
213 (.2%)
Chest Pain
206 (.2%)
Gastrointestinal Haemorrhage
205 (.19%)
Tuberculosis
204 (.19%)
Cardio-respiratory Arrest
202 (.19%)
Pain In Extremity
200 (.19%)

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This graph shows the top adverse events submitted to the FDA for Methotrexate Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Methotrexate Sodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Methotrexate Sodium

What are the most common Methotrexate Sodium adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Methotrexate Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Methotrexate Sodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Methotrexate Sodium According to Those Reporting Adverse Events

Why are people taking Methotrexate Sodium, according to those reporting adverse events to the FDA?

Rheumatoid Arthritis
26419
Drug Use For Unknown Indication
5896
Product Used For Unknown Indication
5788
Psoriatic Arthropathy
1896
Acute Lymphocytic Leukaemia
1625
Prophylaxis Against Graft Versus Ho...
1595
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Psoriasis
1106
Arthritis
894
Crohns Disease
856
Juvenile Arthritis
680
Ankylosing Spondylitis
582
Burkitts Lymphoma
411
Breast Cancer
405
Bone Sarcoma
390
Non-hodgkins Lymphoma
359
Polyarthritis
237
Immunosuppression
233
Central Nervous System Lymphoma
232
Lymphoma
216
Prophylaxis
211
Stem Cell Transplant
211
Neoplasm Malignant
207
Bone Marrow Transplant
199
Diffuse Large B-cell Lymphoma
164
Systemic Lupus Erythematosus
146
Musculoskeletal Pain
135
B Precursor Type Acute Leukaemia
125
Acute Myeloid Leukaemia
124
T-cell Lymphoma
123
B-cell Lymphoma
111
Graft Versus Host Disease
106
Ectopic Pregnancy
104
Dermatomyositis
102
Chemotherapy
101
Mantle Cell Lymphoma
99
Ill-defined Disorder
97
Colitis Ulcerative
89
Cord Blood Transplant Therapy
89
Acute Promyelocytic Leukaemia
88
Wegeners Granulomatosis
80
T-cell Type Acute Leukaemia
68
Gestational Trophoblastic Tumour
68
Sarcoidosis
63
Prophylaxis Against Transplant Reje...
63
Peripheral T-cell Lymphoma Unspecif...
59
Leukaemia
59
Choriocarcinoma
57
Breast Cancer Metastatic
57
Abortion Induced
55
Arthralgia
54
Spondylitis
52

Drug Labels

LabelLabelerEffective
Methotrexate SodiumBryant Ranch Prepack01-AUG-94
Methotrexate SodiumPhysicians Total Care, Inc.30-JUN-10
Methotrexate SodiumREMEDYREPACK INC. 20-JUN-11
Methotrexate SodiumREMEDYREPACK INC. 21-JUL-11
Methotrexate SodiumSandoz Inc19-JAN-12
Methotrexate SodiumRoxane Laboratories, Inc29-FEB-12
Methotrexate SodiumGenPak Solutions LLC09-JUL-12

Methotrexate Sodium Case Reports

What Methotrexate Sodium safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Methotrexate Sodium. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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