Methotrexate can be an effective and usually safe drug, but it does have a long list of dose-dependent side effects. People who have Crohn’s disease typically do not receive this drug in high doses, so, although all of these side effects are possible, people taking it for Crohn’s disease are less likely to develop them. Methotrexate is to be taken only in close consultation and with close follow-up from a healthcare provider and any and all side effects should be discussed with your healthcare provider.
Important Information
Methotrexate prescribing information comes with what’s called a black box warning. This is a special statement at the top of the methotrexate prescribing information that’s surrounded by an outline (which is commonly called a “black box”). The black box warning for methotrexate is quite long and can be a little scary. If there are concerns, talk with a healthcare provider about the risks of methotrexate versus the benefits to health. The risk for certain complications may be more or less, and only a healthcare provider can help put that into perspective. What’s more, it’s important for a healthcare provider to understand individual concerns because every patient will have different ones.
Methotrexate can cause serious birth defects and should not be taken during pregnancy or by women who plan to become pregnant. This is because of the risk of birth defects or fetal death. If you become pregnant while taking methotrexate, notify your healthcare provider immediately.
Some of the key points outlined in the black box warning are:
Methotrexate should only be used under the care of healthcare providers experienced with the use of antimetabolite medicationsMethotrexate should only be used in the case of “disabling disease” that doesn’t respond to other therapyPatients need regular monitoring for toxicities (specifically bone marrow, liver, lung, and kidney)Healthcare providers should educate patients on the risks of therapy with methotrexateMethotrexate should not be used by women who are or who will become pregnant Patients with renal dysfunction, ascites, or pleural effusions require special monitoringToxicities have been reported in people taking high doses of methotrexate along with certain nonsteroidal anti-inflammatory drugs (NSAIDs) Long use of methotrexate can cause hepatotoxicity, fibrosis, cirrhosis, and elevated liver enzymesLung disease has been reported, and any symptoms such as a dry cough should be investigatedIf diarrhea and ulcerative stomatitis occur, the drug needs to be stoppedMalignant lymphomas can occur but may reverse when the drug is stoppedTumor lysis syndrome has been reported and may need to be prevented or treatedSkin reactions are a possibility, usually within days of an injectionInfections have been reported, especially Pneumocystis carinii pneumonia There is a risk of soft tissue necrosis and osteonecrosis when methotrexate is used with radiotherapy The use of proton pump inhibitors (PPIs) can increase the time methotrexate is in the body
Temporary Side Effects
Check with your healthcare provider if any of the following side effects continue or are bothersome:
AcneBoilsLack of appetiteNausea or vomitingPale skinSensitivity to sunlightItching or rashTemporary hair loss
Notify Your Healthcare Provider If You Experience
Back painDark urineDizzinessDrowsinessHeadacheUnusual weakness or fatigueYellow eyes or skin (jaundice)
Notify Your Healthcare Provider Immediately If You Experience
DiarrheaReddening of skinSores on mouth and lipsStomach pain
Less Common or Rare
Allergic reactionBlurred visionChest painsConfusionDead or loose skin layersFever or chillsPinpoint red spots on the skinPainful peeling of skin patchesPainful or difficult urinationRed blisters or ulcers on the lip, mouth, eye, nasal passages, and genital areaReddening of the skin with or without hair lossSeizures (convulsions)Shortness of breath, cough, hoarseness or wheezingSide or lower back painSloughing of skin, muscle, and boneUnusual bleeding or bruising
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your healthcare provider. This information is meant only as a guideline — always consult a healthcare provider or pharmacist for complete information about prescription medications.
