Prescribing Information
Download Prescribing Information

5 WARNINGS AND PRECAUTIONS

5 WARNINGS AND PRECAUTIONS

5.1 Embryo-Fetal Toxicity

Based on published reports and its mechanism of action, methotrexate can cause embryo-fetal toxicity, including fetal death when administered to a pregnant woman.

Methotrexate Injection is contraindicated for use in pregnant women with non-neoplastic diseases. Advise pregnant women with neoplastic diseases of the potential risk to a fetus. The preservative benzyl alcohol can cross the placenta; when possible, use the preservative-free formulation when Methotrexate Injection is needed during pregnancy to treat a neoplastic disease [see Warnings and Precautions (5.3)].

Advise females of reproductive potential to use effective contraception during Methotrexate Injection treatment and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during Methotrexate Injection treatment and for 3 months after the last dose [see Contraindications (4) and Use in Specific Populations (8.1, 8.3, 8.4)].

5.2 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, can occur with methotrexate [see Adverse Reactions (6.1)]. If signs or symptoms of anaphylaxis or any other serious hypersensitivity reaction occurs, immediately discontinue Methotrexate Injection and institute appropriate therapy [see Contraindications (4)].

5.3 Risks of Serious Adverse Reactions due to Benzyl Alcohol-Preservative

Formulations with benzyl alcohol can cause severe central nervous toxicity or metabolic acidosis, if used in neonates or low birth weight infants, intrathecally, or in high-dose regimens. Use only preservative-free Methotrexate Injection for treatment of neonates or low birth weight infants and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required, and preservative-free formulations are not available. The preservative benzyl alcohol can cross the placenta; when possible, use the preservative-free formulation when Methotrexate Injection is needed during pregnancy to treat a neoplastic disease [see Use in Specific Populations (8.1)].

Serious and Fatal Adverse Reactions Including Gasping Syndrome in Neonates and Low Birth Weight Infants

Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and low birth weight infants treated with drugs containing benzyl alcohol, including Methotrexate Injection with preservative. The "gasping syndrome" is characterized by central nervous system (CNS) depression, metabolic acidosis, and gasping respirations.

When prescribing in infants (non-neonate, non-low birth weight), if a preservative-free formulation of Methotrexate Injection is not available and use of a benzyl alcohol-containing formulation is necessary, consider the combined daily metabolic load of benzyl alcohol from all sources including Methotrexate Injection (Methotrexate Injection contains 9.4 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Use in Specific Populations (8.4)].

Neurotoxicity Due to Intrathecal Administration

Serious neurotoxicity can occur following the intrathecal administration of Methotrexate Injection containing the preservative benzyl alcohol.

Metabolic Acidosis with High-Dose Therapy

Severe metabolic acidosis can occur with Methotrexate Injection that contains the preservative benzyl alcohol.

5.4 Myelosuppression

Methotrexate suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, aplastic anemia, leukopenia, neutropenia, and thrombocytopenia [see Adverse Reactions (6.1)].

Obtain blood counts at baseline and periodically during treatment. Monitor patients for possible clinical complications of myelosuppression. Provide supportive care and withhold, reduce dose, or discontinue Methotrexate Injection as needed.

5.5 Serious Infections

Patients treated with methotrexate are at increased risk for developing life-threatening or fatal bacterial, fungal, or viral infections including opportunistic infections such as Pneumocystis jiroveci pneumonia, invasive fungal infections, hepatitis B reactivation, tuberculosis primary infection or reactivation, and disseminated Herpes zoster and cytomegalovirus infections.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Methotrexate Injection. Withhold or discontinue Methotrexate Injection in patients who develop serious infections.

5.6 Renal Toxicity

Methotrexate can cause renal toxicity including irreversible acute renal failure. Monitor renal function and withhold or discontinue Methotrexate Injection as needed for severe renal toxicity.

For patients receiving high-dose regimens, follow recommendations to decrease the risk of renal injury and mitigate renal toxicity [see Dosage and Administration (2.2)].

Patients with impaired renal function are at increased risk for methotrexate toxicity [see Use in Specific Populations (8.6)].

Consider administration of glucarpidase in patients with toxic plasma methotrexate concentrations (>1 micromole per liter) and delayed clearance due to impaired renal function. [see Dosage and Administration (2.2)].

5.7 Hepatotoxicity

Methotrexate can cause severe and potentially irreversible hepatotoxicity including fibrosis, cirrhosis, and fatal liver failure [see Adverse Reactions (6.1, 6.2)].

In patients with psoriasis, fibrosis or cirrhosis may occur in the absence of symptoms or abnormal liver function tests. In patients with psoriasis, the risk of hepatotoxicity appears to increase with total cumulative dose and generally occurs after receipt of a total cumulative dose of 1.5 g or more.

The safety of Methotrexate Injection in patients with liver disease is unknown. Avoid use of Methotrexate Injection in patients with chronic liver disease, unless benefits clearly outweigh the risks. The risk of hepatotoxicity is increased with heavy alcohol consumption.

Assess liver function prior to initiating Methotrexate Injection and monitor liver function tests during treatment. Withhold or discontinue Methotrexate Injection as appropriate.

5.8 Neurotoxicity

Methotrexate can cause severe acute and chronic neurotoxicity which can be progressive, irreversible, and fatal. Serious neurotoxicity, including generalized and focal seizures, have occurred in pediatric patients [see Use in Specific Populations (8.4)]. Monitor patients for signs of neurotoxicity and withhold or discontinue Methotrexate Injection when appropriate.

Leukoencephalopathy

Leukoencephalopathy can occur with intermediate and high-dose intravenous regimens, intrathecal methotrexate, and low-dose methotrexate therapy. The risk of leukoencephalopathy is increased with prior cranial radiation.

Transient Acute Neurologic Syndrome

A transient acute stroke-like syndrome can occur with high-dose methotrexate. Clinical manifestations include confusion, hemiparesis, transient blindness, seizures, and coma.

Neurologic Adverse Reactions Associated with Intrathecal Administration

Intrathecal methotrexate can cause the following additional neurologic adverse reactions:

•
Acute chemical arachnoiditis manifested by symptoms such as headache, back pain, nuchal rigidity, and fever.
•
Subacute myelopathy characterized by paraparesis or paraplegia.

Avoid the intrathecal use of Methotrexate Injection that contains the preservative benzyl alcohol because of the risk of serious neurotoxicity [see Warnings and Precautions (5.3)].

5.9 Gastrointestinal Toxicity

Methotrexate can cause diarrhea, vomiting, stomatitis, hemorrhagic enteritis and fatal intestinal perforation [see Adverse Reactions (6.1)]. Patients with peptic ulcer disease or ulcerative colitis are at a greater risk of developing severe gastrointestinal adverse reactions.

Withhold or discontinue Methotrexate Injection for severe gastrointestinal toxicity, and institute appropriate supportive care as needed.

5.10 Pulmonary Toxicity

Methotrexate-induced pulmonary toxicity including acute or chronic interstitial pneumonitis and irreversible or fatal cases can occur at all dose levels. Monitor patients for signs of pulmonary toxicity and withhold or discontinue Methotrexate Injection as appropriate.

5.11 Dermatologic Reactions

Severe, including fatal, dermatologic reactions, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, and erythema multiforme, can occur with methotrexate [see Adverse Reactions (6.1, 6.2)].

Psoriasis may be aggravated by concomitant exposure to ultraviolet radiation.

Methotrexate can cause radiation recall, photodermatitis (sunburn) reactivation, photosensitivity, and severe sunburn reactions. Advise patients to limit sun exposure while taking Methotrexate Injection. Advise patients when outdoors to wear a hat and protective clothing and use a broad-spectrum Ultraviolet A (UVA)/Ultraviolet B (UVB) sunscreen and lip balm (SPF ≥30) to help protect against sunburn.

Monitor patients for signs of dermatologic toxicity and withhold or permanently discontinue Methotrexate Injection for severe dermatologic adverse reactions.

5.12 Folic Acid Supplementation

Neoplastic Diseases

Products containing folic acid or its derivatives may decrease the clinical effectiveness of methotrexate. Avoid use of products containing folic acid or folinic acid unless clinically indicated [see Drug Interactions (7.1)].

Non-neoplastic Diseases

Folate deficiency may increase methotrexate adverse reactions. Administer folic acid or folinic acid to patients with rheumatoid arthritis, pJIA, and psoriasis [see Dosage and Administration (2.10, 2.11, 2.12)].

5.13 Secondary Malignancies

Secondary malignancies can occur at all dose levels of methotrexate. In some cases, lymphoproliferative disease that occurred during therapy with low-dose methotrexate regressed completely following withdrawal of methotrexate. If lymphoproliferative disease occurs, discontinue Methotrexate Injection and institute appropriate treatment if lymphoma does not regress.

5.14 Tumor Lysis Syndrome

Methotrexate can induce tumor lysis syndrome in patients with rapidly growing tumors. Institute appropriate treatment for prevention and management of tumor lysis syndrome.

5.15 Immunization and Risks Associated with Live Vaccines

Immunization during Methotrexate Injection treatment may be ineffective.

Disseminated infections following administration of live vaccines have been reported.

Update immunizations according to immunization guidelines prior to initiating Methotrexate Injection. Immunization with live vaccines is not recommended during treatment. The interval between live vaccinations and initiation of Methotrexate Injection should be in accordance with current vaccination guidelines for patients on immunosuppressive therapies.

5.16 Infertility

Based on published reports, methotrexate can cause impairment of fertility, oligospermia, and menstrual dysfunction. It is not known if the infertility may be reversible in affected patients. Discuss the risk of effects on reproduction with female and male patients of reproductive potential [see Use in Specific Populations (8.3)].

5.17 Increased Risk of Adverse Reactions Due to Third-Space Accumulation

Methotrexate can exit slowly from third-space accumulations resulting in prolonged terminal plasma half-life and toxicity. Evacuate significant third-space accumulations prior to Methotrexate Injection administration [see Clinical Pharmacology (12.3)].

5.18 Increased Risk of Soft Tissue and Bone Toxicity with Concomitant Radiotherapy

Concomitant radiation therapy increases the risk of soft tissue necrosis and osteonecrosis associated with methotrexate.

5.19 Risk of Serious Adverse Reactions with Medication Errors

Serious adverse reactions, including death, have occurred due to medication errors. Most commonly, these errors occurred in patients who were taking methotrexate daily when a weekly dosing regimen was prescribed. Ensure that patients receive the recommended dosage, because medication errors have led to death.

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration.     Issued: 05/2025

Patient Information
METHOTREXATE (Meth-oh-trex-ate)
Injection
for intravenous, intramuscular,
subcutaneous, or intrathecal use

What is the most important information I should know about Methotrexate Injection?
Methotrexate Injection can cause serious side effects that may be severe and lead to death, including:
Harm to an unborn baby, including birth defects or death of an unborn baby.
Females who can become pregnant:

•
Your healthcare provider should do a pregnancy test before you start taking Methotrexate Injection to see if you are pregnant.
•
If you are being treated for a medical condition other than cancer, do not receive or take Methotrexate Injection if you are pregnant. See “Do not receive Methotrexate Injection if”.
•
If you are taking Methotrexate Injection to treat your cancer, you and your healthcare provider will decide if you will receive or take Methotrexate Injection if you are pregnant.
•
Use effective birth control (contraception) during treatment and for 6 months after your last dose of Methotrexate Injection. Ask your healthcare provider what forms of birth control you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Methotrexate Injection.

Males with female partners who are able to become pregnant:

•
Use effective birth control during treatment and for 3 months after your last dose of Methotrexate Injection.
Tell your healthcare provider right away if your female partner becomes pregnant during treatment with Methotrexate Injection.

Severe allergic reactions. Severe allergic reactions can happen with Methotrexate Injection.

•
Do not receive Methotrexate Injection if you have had a severe allergic reaction to methotrexate in the past.
Get medical help right away if you develop any of the signs or symptoms of a severe allergic reaction to Methotrexate Injection, including:
o
skin rash, itching, and hives
o
swelling of the face, lips, tongue, or throat, or trouble swallowing
o
dizziness or lightheadedness
o
trouble breathing
o
wheezing
o
throat tightness
o
runny or stuffy nose
o
fast heart rate
o
chest pain
o
feeling faint

Decreased blood cell counts. Methotrexate Injection can affect your bone marrow and cause decreased red blood cell counts, white blood cell counts, and platelet counts, and a condition where your bone marrow cannot produce these blood cells (aplastic anemia). These decreased blood cell counts can be severe and may lead to a serious infection, the need for blood transfusions, treatment in a hospital, and can be life-threatening. Your healthcare provider will check your blood cell counts before you start and during treatment with Methotrexate Injection. Your healthcare provider will watch you closely for infections during treatment with Methotrexate Injection.
Call your healthcare provider right away if you develop:

•
a new fever (temperature of 100.4°F or higher)
•
symptoms of infection
•
easy bruising or bleeding that will not stop

Your healthcare provider may give you medicines to support your blood counts or give you transfusions if needed, and change your dose or stop your treatment with Methotrexate Injection if needed.
Serious infections. People who receive treatment with Methotrexate Injection have an increased risk of developing serious infections that can be life-threatening or lead to death. These infections include:

•
bacterial infections
•
fungal infections
•
viral infections
•
certain infections that happen because your immune system is weakened
•
hepatitis B infection that comes back (reactivation)
•
tuberculosis (TB) infection that is new or that comes back (reactivation)
•
shingles (herpes zoster)
•
cytomegalovirus infections

Your healthcare provider will closely watch you for signs and symptoms of infection during treatment with Methotrexate Injection. Your healthcare provider may hold or stop your treatment with Methotrexate Injection if you develop a serious infection.
Kidney problems. Methotrexate Injection can cause kidney damage including sudden kidney failure that may not go away (irreversible). People who already have kidney problems have an increased risk of kidney problems with Methotrexate Injection. Your healthcare provider will check your kidney function during treatment, and will hold or stop Methotrexate Injection treatment as needed for severe kidney damage.
Call your healthcare provider right away if you have signs or symptoms of kidney problems such as a big change in the amount of urine that you make, either increased or decreased.
Liver problems. Methotrexate Injection can cause severe liver problems including liver scarring (fibrosis), cirrhosis, and liver failure that may not get better (possibly irreversible) and can cause death.

•
In people with psoriasis who receive Methotrexate Injection, liver fibrosis or cirrhosis may happen without any symptoms or abnormal liver tests. The risk for liver problems in people with psoriasis increases with the amount of Methotrexate Injection that you receive over time.
•
Your healthcare provider will do tests to monitor your liver function before you start and during treatment with Methotrexate Injection, and may hold or stop your treatment with Methotrexate Injection, if needed.
•
The risk of liver problems is increased with heavy use of alcohol. Avoid drinking alcohol during Methotrexate Injection treatment.

Tell your healthcare provider if you develop any signs or symptoms of liver problems during treatment with Methotrexate Injection, including:

•
tiredness
•
easy bleeding or bruising
•
loss of appetite
•
nausea
•
difficulty thinking clearly
•
swelling in your legs, feet, or ankles
•
weight loss
•
itchy skin
•
yellowing of your skin or the white part of your eyes
•
weakness

Brain and spinal cord (nervous system) problems. Methotrexate Injection can cause nervous system problems that can be severe and last for a short time or last for a long time. These nervous system problems can get progressively worse, may not get better (possibly irreversible), and can cause death.

•
Serious nervous system problems can happen in children who receive Methotrexate Injection, including seizures that can begin on one side of the brain (focal seizures) or on both sides of the brain (generalized seizures).
•
The risk for a nervous system problem called leukoencephalopathy is increased in people who have had radiation treatment to their head and spine (craniospinal irradiation) in the past. Call your healthcare provider if you develop any new neurological symptoms.
•
People who receive high-dose Methotrexate Injection can develop sudden symptoms that are like the symptoms of a stroke, but they last a short time and may go away (transient).
•
People who receive injections of Methotrexate Injection into their spine (intrathecal methotrexate) can develop inflammation of the lining around the spinal nerves.

Call your healthcare provider right away if you or your child develop any new signs or symptoms of a nervous system problem during treatment with Methotrexate Injection, including:

•
confusion
•
weakness on one side of your body
•
sudden blindness that goes away
•
seizures
•
coma
•
headache
•
back pain
•
stiff neck
•
fever

Severe stomach and intestine (gastrointestinal) problems.
Methotrexate Injection can cause diarrhea, vomiting, mouth sores, stomach and intestinal inflammation with severe bleeding, and tears in the intestinal wall (perforation), and can lead to death.

•
People who have stomach ulcers (peptic ulcer disease) or ulcerative colitis (UC) have a higher risk of developing severe stomach and intestine problems with Methotrexate Injection.
•
Your healthcare provider may hold or stop your treatment with Methotrexate Injection if any of these severe stomach and intestinal problems happen, and treat you as needed.
•
Call your healthcare provider if you develop diarrhea, vomiting, inflammation or sores in your mouth.

Call your healthcare provider right away if you develop:

o
high fever
o
shaking chills
o
stomach-area (abdomen) pain that is severe or does not go away.
o
severe constipation
o
if you are vomiting blood
o
blood in your stools

Lung problems. Lung problems can happen suddenly (acute) with Methotrexate Injection or they can develop over a long period-of-time (chronic). Lung problems may not get better (possibly irreversible) and can cause death in anyone taking Methotrexate Injection. Your healthcare provider will monitor you for lung problems during treatment with Methotrexate Injection. Your healthcare provider may hold or stop your treatment with Methotrexate Injection, if needed.
Call your healthcare provider if you develop symptoms of a lung problem, including: cough, fever, and trouble breathing.
Skin reactions. Severe skin reactions can happen with Methotrexate Injection, that can be serious and can lead to death.

•
In people with psoriasis: Your psoriasis may get worse if you are exposed to sunlight or other types of ultraviolet light.
•
Methotrexate Injection can cause reactivation of skin reactions that can happen after radiation therapy (radiation recall), sunburns to come back (photodermatitis) and severe sunburn reactions.

Limit sunlight exposure during treatment with Methotrexate Injection. Use a broad-spectrum ultraviolet sunscreen and lip balm with a Sun Protection Factor (SPF) of 30 or greater and wear a hat and protective clothing when you will be exposed to sunlight during treatment with Methotrexate Injection.

Call your healthcare provider right away if you develop a new or worsening skin rash during treatment with Methotrexate Injection.

See “What are the possible side effects of Methotrexate Injection?” for more information about side effects.

What is Methotrexate Injection?
Methotrexate Injection is a prescription medicine used:
in adults and children:

•
in combination with other chemotherapy medicines to treat acute lymphoblastic leukemia (ALL) to help prevent (prophylaxis) and to treat leukemia that spreads to the covering of the brain and spinal cord (meninges).
•
to treat non-Hodgkin lymphoma
•
in combination with other chemotherapy medicines to treat osteosarcoma

in adults:

•
in combination with other chemotherapy medicines to treat breast cancer
•
alone to treat squamous cell carcinoma of the head and neck
•
in combination with other chemotherapy medicines to treat gestational trophoblastic neoplasia

Methotrexate Injection is a prescription medicine used:

•
in adults to treat rheumatoid arthritis (RA)
•
in children to treat polyarticular juvenile idiopathic arthritis (pJIA)
•
in adults to treat severe psoriasis

Do not receive Methotrexate Injection if you:

•
have had a severe allergic reaction to Methotrexate Injection. See “What is the most important information I should know about Methotrexate Injection?”
•
you are pregnant and are being treated, or will be treated with Methotrexate Injection for rheumatoid arthritis, pJIA, or severe psoriasis, or for any disease other than cancer. Methotrexate Injection can cause harm to an unborn baby including birth defects or death of an unborn baby. See “What is the most important information I should know about Methotrexate Injection?”

Before you receive Methotrexate Injection, tell your healthcare provider about all of your medical conditions, including if you:

•
have kidney problems or are receiving dialysis treatments
•
have liver problems
•
have a history of neurologic problems, including seizures
•
drink alcohol-containing beverages during treatment with Methotrexate Injection, or if there are any changes in the amount of alcoholic beverages you drink
•
have fluid in your stomach-area (ascites)
•
have lung problems or fluid in your lungs (pleural effusion)
•
plan to have any surgeries with general anesthesia, including dental surgery
•
have stomach ulcers (peptic ulcer disease)
•
have ulcerative colitis
•
have recently received or are scheduled to receive a vaccine. You should not receive live vaccines during treatment with Methotrexate Injection.
•
are breastfeeding or plan to breastfeed. Methotrexate may pass into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of Methotrexate Injection.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines can affect the amount of methotrexate in your blood and can increase your risk for serious side effects.

How will I receive or take Methotrexate Injection?

•
Depending on your medical condition and the dose of Methotrexate Injection that is prescribed by your healthcare provider, Methotrexate Injection can be given to you:
o
through an intravenous (IV) line in your vein
o
by injection into a large muscle (intramuscular injection)
o
injected under your skin (subcutaneous injection)
o
for certain diseases the preservative-free formulation of Methotrexate Injection can also be injected through your spine directly into your spinal fluid.

If you are receiving Methotrexate Injection to treat your cancer:

•
Your healthcare provider will decide your dose, how you will receive Methotrexate Injection, and how often you need to receive it, depending on your medical condition that is being treated.
•
If you are receiving high-dose Methotrexate Injection to treat your cancer, you will receive the medicine leucovorin to help prevent severe side effects ("rescue") to your bone marrow and other normal cells in your body. You will also receive intravenous (IV) fluids and other medicines to help prevent and treat side effects.
•
If you are receiving a "moderate-dose" of Methotrexate Injection to treat your cancer, you may also receive leucovorin.
•
Do not take folic acid or folinic acid during treatment with Methotrexate Injection to treat your cancer, unless your healthcare provider tells you to. Taking folic acid or folinic acid with Methotrexate Injection may make your treatment less effective.
•
Your healthcare provider will do blood tests to check for side effects during treatment with Methotrexate Injection.
•
Your healthcare provider may stop your treatment, change when you receive your treatment, or change the dose of your treatment if you have certain side effects while receiving Methotrexate Injection.

If you are receiving Methotrexate Injection for treatment of severe psoriasis, rheumatoid arthritis, or polyarticular juvenile idiopathic arthritis:

•
You should receive your Methotrexate Injection dose 1 time each week, not every day. Serious side effects and death have happened in people who mistakenly have taken Methotrexate Injection every day instead of 1 time each week.
•
Take folic acid or folinic acid every day during treatment with Methotrexate Injection, as instructed by your healthcare provider, to help reduce the chance of developing certain side effects, such as mouth sores.
•
If you receive too much Methotrexate Injection call your healthcare provider or go to your nearest hospital emergency room right way. You will need to receive a medicine as soon as possible to help reduce side effects that could be severe and could cause death.

In all patients receiving Methotrexate Injection:

•
If you miss receiving a dose of Methotrexate Injection, call your healthcare provider for instructions about when to receive your next dose of Methotrexate Injection.

What are the possible side effects of Methotrexate Injection?
Methotrexate Injection can cause serious side effects, including:

•
See “What is the most important information I should know about Methotrexate Injection?”
•
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS if you are receiving Methotrexate Injection as a cancer treatment. Your healthcare provider will treat you as needed to prevent or manage TLS if you develop it during treatment with Methotrexate Injection.
•
New (secondary) cancers. New (secondary) cancers can happen in people who take or receive Methotrexate Injection at any dose.
o
Certain blood cancers can happen during treatment with low-dose Methotrexate Injection. In some cases, these blood cancers may completely go away (regress completely) after Methotrexate Injection is stopped.
o
If you develop one of these blood cancers during treatment with Methotrexate Injection, your healthcare provider will stop your treatment, and treat as needed if the new cancer does not go away after Methotrexate Injection is stopped.
•
Increased risk of soft tissue and bone problems due to receiving Methotrexate Injection in combination with radiation therapy. In people who receive Methotrexate Injection, some soft tissue in your body may die and some bone cells may die. People who receive radiation therapy in combination with Methotrexate Injection have an increased risk of this happening.

The most common side effects of Methotrexate Injection include:

•
mouth sores or ulcers
•
nausea
•
decreased white blood cell count. See “What is the most important information I should know about Methotrexate Injection?”
•
upset stomach

Possible fertility problems (infertility) in males and females. Methotrexate Injection can cause fertility problems in males and females, and cause sperm production to stop in males, and menstrual problems in females. In females, your periods (menstrual cycle) may be irregular or completely stop when you receive Methotrexate Injection. Your periods may or may not return to normal following treatment. It is not known if your fertility will return after treatment. Talk to your healthcare provider about your risk for infertility if this is a concern for you.
These are not all of the possible side effects of Methotrexate Injection.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Methotrexate Injection.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
You can ask your pharmacist or healthcare provider for information about Methotrexate Injection that is written for health professionals.

What are the ingredients in Methotrexate Injection?
Active ingredient: methotrexate.
Inactive ingredients for Methotrexate Injection Preservative-free: sodium chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH to 8.5.
Inactive ingredients for Methotrexate Injection with Preservative: benzyl alcohol and sodium chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH to 8.5.

Distributed by Hospira, Inc. Lake Forest, IL 60045
LAB-1468-2.0

Logo

For more information, go to www.pfizer.com or call 1-800-438-1985.

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.