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Methotrexate Side Effects

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Common Methotrexate Side Effects


The most commonly reported Methotrexate side effects (click to view or check a box to report):

Pyrexia (411)
Pancytopenia (356)
Nausea (321)
Pneumonia (304)
Arthralgia (271)
Headache (269)
Injection Site Pain (265)
Rheumatoid Arthritis (260)
Dyspnoea (248)
Mucosal Inflammation (241)
Diarrhoea (238)
Vomiting (231)
Fatigue (223)
Asthenia (198)
Cough (196)
Sepsis (195)
Anaemia (195)
Pain (188)
Renal Failure Acute (177)
Malaise (156)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Methotrexate Side Effects Reported to FDA



Methotrexate Side Effect Report#9999551
Bone Marrow Failure, Stomatitis, Staphylococcal Sepsis
This is a report of a 61-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: eczema, who was treated with Methotrexate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Bone Marrow Failure, Stomatitis, Staphylococcal Sepsis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methotrexate treatment in female patients, resulting in Bone Marrow Failure side effect. The patient was hospitalized.
Methotrexate Side Effect Report#9999342
Hepatic Function Abnormal, Hypoaesthesia, Tremor, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
This report suggests a potential Methotrexate Hepatic Function Abnormal side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: gastric cancer and used Methotrexate (dosage: NA) starting NS. After starting Methotrexate the patient began experiencing various side effects, including: Hepatic Function Abnormal, Hypoaesthesia, Tremor, Aspartate Aminotransferase Increased, Alanine Aminotransferase IncreasedAdditional drugs used concurrently:
  • Fluorouracil
  • Folinic Acid
Although Methotrexate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Function Abnormal, may still occur.
Methotrexate Side Effect Report#9999306
Progressive Multifocal Leukoencephalopathy
This Progressive Multifocal Leukoencephalopathy problem was reported by a physician from CA. A 84-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On NS this consumer started treatment with Methotrexate (dosage: NA). The following drugs were being taken at the same time: NA. When using Methotrexate, the patient experienced the following unwanted symptoms/side effects: Progressive Multifocal LeukoencephalopathyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Progressive Multifocal Leukoencephalopathy, may become evident only after a product is in use by the general population.
Methotrexate Side Effect Report#9999182
Off Label Use, Hypomagnesaemia
This Off Label Use side effect was reported by a pharmacist from GB. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis,gastrooesophageal reflux disease.The patient was prescribed Methotrexate (drug dosage: NA), which was initiated on
Nov 29, 2010. Concurrently used drugs:
  • Omeprazole
  • Amlodipine
  • Folate Sodium/folic Acid
  • Calcichew D3
.After starting to take Methotrexate the consumer reported adverse symptoms, such as: Off Label Use, HypomagnesaemiaThese side effects may potentially be related to Methotrexate. The patient was hospitalized and became disabled.
Methotrexate Side Effect Report#9999068
Off Label Use
This is a report of a 38-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: tolosa-hunt syndrome, who was treated with Methotrexate (dosage: NA, start time: NS), combined with:
  • Prednisolone
and developed a serious reaction and side effect(s): Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methotrexate treatment in male patients, resulting in Off Label Use side effect.
Methotrexate Side Effect Report#9996162
Nausea, Dizziness, Abdominal Discomfort, Arthralgia, Back Pain, Crying, Headache, Sensory Disturbance, Mood Swings
This report suggests a potential Methotrexate Sodium Nausea side effect(s) that can have serious consequences. A 43-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Methotrexate Sodium (dosage: NA) starting NS. After starting Methotrexate Sodium the patient began experiencing various side effects, including: Nausea, Dizziness, Abdominal Discomfort, Arthralgia, Back Pain, Crying, Headache, Sensory Disturbance, Mood SwingsAdditional drugs used concurrently: NA. Although Methotrexate Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nausea, may still occur.
Methotrexate Side Effect Report#9995845
Convulsion, Neurotoxicity
This Convulsion problem was reported by a pharmacist from US. A 5-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: acute lymphocytic leukaemia. On
Jan 31, 2014 this consumer started treatment with Methotrexate 12 Mg (dosage: 12 Mg Every 28 Days Intrathecal). The following drugs were being taken at the same time:
  • Vincristine
  • Mercaptopurine
  • Ondansetron
  • Dexamethasone
When using Methotrexate 12 Mg, the patient experienced the following unwanted symptoms/side effects: Convulsion, NeurotoxicityThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Convulsion, may become evident only after a product is in use by the general population.
Methotrexate Side Effect Report#9995510
Hyperhidrosis, Asthenia, Lung Disorder, Dyspnoea
This Hyperhidrosis side effect was reported by a consumer or non-health professional from US. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Methotrexate 2.5 (drug dosage: 2 Puffs Twice Daily At Bedtime), which was initiated on 201201. Concurrently used drugs:
  • Walker Seat
  • Wheelchair
  • Oxyen Tank
  • Pro Air Hfa - 90 Mcg Albuterol Per Actuation Manufactured In Ireland - Marketd By Teva
  • Cyclobenzaprine
  • Acetaminophen-oxycodone
  • Sulfamethoxzole
  • Prednisone
.After starting to take Methotrexate 2.5 the consumer reported adverse symptoms, such as: Hyperhidrosis, Asthenia, Lung Disorder, DyspnoeaThese side effects may potentially be related to Methotrexate 2.5. The patient was hospitalized and became disabled.
Methotrexate Side Effect Report#9992550
Arthralgia, Bone Pain, Joint Swelling
This is a report of a 50-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Methotrexate (dosage: Unk, start time: NS), combined with:
  • Xeljanz (5 Mg, 2x/day)
and developed a serious reaction and side effect(s): Arthralgia, Bone Pain, Joint Swelling after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methotrexate treatment in male patients, resulting in Arthralgia side effect.
Methotrexate Side Effect Report#9990855
Blood Creatinine Increased
This report suggests a potential Methotrexate Blood Creatinine Increased side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: lymphoma and used Methotrexate (dosage: 4.5366m, One, Iv) starting
Sep 12, 2013. After starting Methotrexate the patient began experiencing various side effects, including: Blood Creatinine IncreasedAdditional drugs used concurrently: NA. Although Methotrexate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Creatinine Increased, may still occur.
Methotrexate Side Effect Report#9990847
Toxicity To Various Agents, Blood Creatinine Increased
This Toxicity To Various Agents problem was reported by a pharmacist from US. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: brain neoplasm. On
Feb 18, 2014 this consumer started treatment with Methotrexate (dosage: NA). The following drugs were being taken at the same time: NA. When using Methotrexate, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Blood Creatinine IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Methotrexate Side Effect Report#9990840
Blood Creatinine Increased
This Blood Creatinine Increased side effect was reported by a health professional from US. A 61-year-old male patient (weight:NA) experienced the following symptoms/conditions: lymphoma.The patient was prescribed Methotrexate (drug dosage: NA), which was initiated on
Feb 18, 2014. Concurrently used drugs: NA..After starting to take Methotrexate the consumer reported adverse symptoms, such as: Blood Creatinine IncreasedThese side effects may potentially be related to Methotrexate.
Methotrexate Side Effect Report#9989207
Encephalopathy
This is a report of a 67-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: lymphoma, who was treated with Methotrexate (dosage: NA, start time: NS), combined with:
  • Cytarabine
  • Cyclophosphamid
  • Doxorubicin Hydrochloride
  • Vincristine
  • Prednisolone
and developed a serious reaction and side effect(s): Encephalopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methotrexate treatment in male patients, resulting in Encephalopathy side effect.
Methotrexate Side Effect Report#9989172
Abasia, Pain
This report suggests a potential Methotrexate Abasia side effect(s) that can have serious consequences. A 30-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Methotrexate (dosage: NA) starting
Jun 04, 2010. After starting Methotrexate the patient began experiencing various side effects, including: Abasia, PainAdditional drugs used concurrently:
  • Etanercept
Although Methotrexate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abasia, may still occur.
Methotrexate Side Effect Report#9989168
Off Label Use, Uveitis, Back Pain, Pain, Ocular Hyperaemia
This Off Label Use problem was reported by a consumer or non-health professional from US. A 36-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: ankylosing spondylitis. On NS this consumer started treatment with Methotrexate (dosage: NA). The following drugs were being taken at the same time: NA. When using Methotrexate, the patient experienced the following unwanted symptoms/side effects: Off Label Use, Uveitis, Back Pain, Pain, Ocular HyperaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Off Label Use, may become evident only after a product is in use by the general population.
Methotrexate Side Effect Report#9981203
Exposure Via Father, Large For Dates Baby, Deafness Congenital
This Exposure Via Father side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: psoriatic arthropathy.The patient was prescribed Methotrexate (drug dosage: NA), which was initiated on
Sep 10, 2012. Concurrently used drugs: NA..After starting to take Methotrexate the consumer reported adverse symptoms, such as: Exposure Via Father, Large For Dates Baby, Deafness CongenitalThese side effects may potentially be related to Methotrexate. The patient was hospitalized.
Methotrexate Side Effect Report#9980808
Dyspnoea, Asthenia, Deep Vein Thrombosis, Retroperitoneal Haemorrhage, Mental Status Changes, Sepsis, Shock Haemorrhagic, Metabolic Acidosis, Multi-organ Failure
This is a report of a 60-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Methotrexate (dosage: NA, start time: NS), combined with:
  • Procarbazine
  • Rituximab
and developed a serious reaction and side effect(s): Dyspnoea, Asthenia, Deep Vein Thrombosis, Retroperitoneal Haemorrhage, Mental Status Changes, Sepsis, Shock Haemorrhagic, Metabolic Acidosis, Multi-organ Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methotrexate treatment in female patients, resulting in Dyspnoea side effect. The patient was hospitalized.
Methotrexate Side Effect Report#9980783
Off Label Use, Parakeratosis
This report suggests a potential Methotrexate Off Label Use side effect(s) that can have serious consequences. A 17-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: morphoea and used Methotrexate (dosage: Methotrexate Received Over The Course Of 19 Months With Total Of 34 Excimer Treatments) starting NS. After starting Methotrexate the patient began experiencing various side effects, including: Off Label Use, ParakeratosisAdditional drugs used concurrently: NA. Although Methotrexate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Off Label Use, may still occur.
Methotrexate Side Effect Report#9980734
Streptococcal Bacteraemia
This Streptococcal Bacteraemia problem was reported by a consumer or non-health professional from KR. A 33-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Methotrexate (dosage: NA). The following drugs were being taken at the same time:
  • Prednisolone
  • Cyclophosphamide
  • Busulfan
When using Methotrexate, the patient experienced the following unwanted symptoms/side effects: Streptococcal BacteraemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Streptococcal Bacteraemia, may become evident only after a product is in use by the general population.
Methotrexate Side Effect Report#9972295
Arthritis, Nervous System Disorder
This Arthritis side effect was reported by a health professional from GB. A 33-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Methotrexate (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Methotrexate the consumer reported adverse symptoms, such as: Arthritis, Nervous System DisorderThese side effects may potentially be related to Methotrexate. The patient was hospitalized.
Methotrexate Side Effect Report#9970033
Uveitis, Liver Disorder, Overweight
This is a report of a 55-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: psoriatic arthropathy, who was treated with Methotrexate (dosage: NA, start time: 2011), combined with:
  • Enbrel
  • Onbrize
and developed a serious reaction and side effect(s): Uveitis, Liver Disorder, Overweight after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methotrexate treatment in male patients, resulting in Uveitis side effect.
Methotrexate Side Effect Report#9970031
Shoulder Arthroplasty, Nausea, Abdominal Discomfort
This report suggests a potential Methotrexate Shoulder Arthroplasty side effect(s) that can have serious consequences. A 59-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Methotrexate (dosage: NA) starting NS. After starting Methotrexate the patient began experiencing various side effects, including: Shoulder Arthroplasty, Nausea, Abdominal DiscomfortAdditional drugs used concurrently:
  • Enbrel
The patient was hospitalized. Although Methotrexate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Shoulder Arthroplasty, may still occur.
Methotrexate Side Effect Report#9969710
Chills, Demyelination
This Chills problem was reported by a physician from GB. A 26-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: osteosarcoma. On
Apr 12, 2013 this consumer started treatment with Methotrexate (dosage: NA). The following drugs were being taken at the same time:
  • Mepact (Unk)
  • Cisplatin (Unk)
  • Doxorubicin (Unk)
When using Methotrexate, the patient experienced the following unwanted symptoms/side effects: Chills, DemyelinationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Chills, may become evident only after a product is in use by the general population.
Methotrexate Side Effect Report#9969415
Herpes Zoster Disseminated, Dermatitis Bullous, Ulcer, Immunosuppression
This Herpes Zoster Disseminated side effect was reported by a health professional from JP. A 84-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Methotrexate (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Prednisolone
  • Mizoribine
.After starting to take Methotrexate the consumer reported adverse symptoms, such as: Herpes Zoster Disseminated, Dermatitis Bullous, Ulcer, ImmunosuppressionThese side effects may potentially be related to Methotrexate.
Methotrexate Side Effect Report#9967131
Deafness Congenital, Large For Dates Baby, Exposure Via Father
This is a report of a female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: psoriasis, who was treated with Methotrexate (dosage: 15 [mg/wk (vater) ], start time:
Sep 10, 2012), combined with:
  • Folic Acid (5 [mg/d (mutter) ])
and developed a serious reaction and side effect(s): Deafness Congenital, Large For Dates Baby, Exposure Via Father after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Methotrexate treatment in female patients, resulting in Deafness Congenital side effect.


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The appearance of Methotrexate on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Methotrexate Side Effects for Women?

Women Side EffectsReports
Pancytopenia 242
Pyrexia 230
Nausea 223
Injection Site Pain 215
Rheumatoid Arthritis 205
Arthralgia 190
Headache 185
Pneumonia 185
Dyspnoea 170
Fatigue 163

What are common Methotrexate Side Effects for Men?

Men Side EffectsReports
Pyrexia 177
Mucosal Inflammation 120
Pneumonia 119
Pancytopenia 113
Renal Failure Acute 98
Nausea 95
Febrile Neutropenia 93
Diarrhoea 82
Headache 82
Vomiting 82

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Methotrexate reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Methotrexate Side Effects

    Did You Have a Methotrexate Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Methotrexate for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Methotrexate Safety Alerts, Active Ingredients, Usage Information

    NDC0054-4550
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameMethotrexate Sodium
    NameMethotrexate Sodium
    Dosage FormTABLET
    RouteORAL
    On market since19940801
    LabelerRoxane Laboratories, Inc
    Active Ingredient(s)METHOTREXATE SODIUM
    Strength(s)2.5
    Unit(s)mg/1
    Pharma ClassFolate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]

    Methotrexate Dosage, Warnings, Usage.

    Side Effects reported to FDA: 9127

    Methotrexate safety alerts: 2014 2010 2005

    Reported deaths: 1253

    Reported hospitalizations: 3492

    Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates

    [Posted 10/29/2010]

    AUDIENCE: Pharmacy, Risk Manager

    ISSUE: Sandoz and FDA notified healthcare professionals of a recall of Methotrexate Injection, 50mg/2mL and 250mg/10mL vials, due to small glass flakes detected in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of the two dosage presentations.

    Parenteral injection of drug from the affected lots could lead to serious adverse events in areas where the particles lodge. Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation. Neurologic damage could result from intrathecal administration.

    BACKGROUND: Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.

    RECOMMENDATION: Customers and patients should immediately discontinue use of this product and patients should contact their physician or healthcare provider if they experience any problem that might be related to the use of this product. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

    Product lot numbers, label type, expiration dates, and recall instructions are listed in the Press Release.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [10/27/2010 - Press Release - Sandoz Inc.]

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