Trexall side effects: What you should know

Trexall (methotrexate) is a brand-name drug that’s prescribed for psoriasis, rheumatoid arthritis, and certain types of cancers in adults and some children. As with other drugs, Trexall can cause side effects, such as nausea and vomiting.
Trexall has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section below.
boxed warnings
Side effect specifics
More common side effects of Trexall
Trexall can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Trexall in clinical trials:
clinical trials
nausea and vomiting
stomatitis (mouth sores)
stomatitis
stomach pain or discomfort
diarrhea
dizziness
Mild side effects of Trexall
Mild side effects can occur with Trexall use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Trexall’s prescribing information.
prescribing information
Mild side effects that have been reported with Trexall include:
stomach pain or discomfort
nausea and vomiting
diarrhea
stomatitis (mouth sores)
dizziness
hair loss
fatigue
fever or chills
headache
skin sensitivity to sunlight
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the FDA approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Trexall and want to tell the FDA about it, visit MedWatch.
MedWatch
Serious side effects of Trexall
Trexall may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Trexall’s prescribing information.
prescribing information
If you develop serious side effects while taking Trexall, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported and their symptoms include:
Lymphoma (cancer in the lymph nodes), which may include symptoms such as: swollen lymph nodesfeverloss of appetitetiredness
Lymphoma
swollen lymph nodes
swollen lymph nodes
fever
loss of appetite
tiredness
Serious infections, which may include symptoms such as: shortness of breathfevercough
infections
shortness of breath
fever
cough
Tumor lysis syndrome (cancer cells release harmful chemicals into the body), which may include symptoms such as: muscle cramping or weaknessheart palpitations (fast or irregular heartbeat)diarrheafatiguenumbness
Tumor lysis syndrome
muscle cramping or weakness
heart palpitations (fast or irregular heartbeat)
heart palpitations
diarrhea
fatigue
fatigue
numbness
risk of kidney problems*
risk of lung problems*
risk of serious skin reactions*
risk of gastrointestinal (GI) problems*
risk of blood disorders*
risk of liver problems*
* For more information about this side effect, see “Side effect specifics” below.
For some people, Trexall can cause an allergic reaction.
allergic reaction
In general, symptoms of allergic reaction can be mild or serious.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Trexall, your doctor may recommend taking a different medication instead.
Side effect specifics
Learn more about some of the side effects that Trexall may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Trexall.
prescribing information
Trexall has several boxed warnings about the possible risks of taking the medication. A boxed warning is the most serious warning from the FDA. The warnings alert doctors and patients about drug effects that may be dangerous.
boxed warnings
Trexall can cause liver problems in some people who take the drug. Elevated liver enzymes were a commonly reported side effect in the drug’s clinical trials. Liver enzymes that are higher than usual may be a sign of liver damage. In rare cases, Trexall can cause serious liver problems, such as fibrosis, cirrhosis, or liver failure.
Elevated liver enzymes
clinical trials
fibrosis
cirrhosis
liver failure
Symptoms of liver problems may include:
abdominal pain
vomiting
itching
dark-colored urine
jaundice (yellowing of the skin or whites of your eyes)
jaundice
In people with psoriasis, liver damage can happen without having elevated liver enzymes or experiencing any symptoms.
The risk of liver problems increases with long-term use or heavy alcohol consumption. In some cases, liver damage caused by Trexall may not be reversible.
What you can do
Your doctor will order regular blood tests called liver function tests (LFT) to check the health of your liver during treatment with Trexall. If your blood tests show any signs of liver damage, your doctor may have you temporarily or permanently stop treatment with Trexall. If you notice any signs of liver problems, contact your doctor right away.
liver function tests (LFT)
Trexall can cause serious kidney damage in some people, including permanent kidney failure. This was a rare side effect reported in the drug’s clinical trials.
kidney failure
clinical trials
Symptoms of kidney problems may include:
swelling in the legs and feet
confusion
metallic taste in the mouth
metallic taste in the mouth
itchy skin
producing more or less urine than usual
What you can do
Your doctor will order regular blood tests to monitor your kidneys during treatment with Trexall. If your blood tests suggest that your kidneys aren’t working as well as usual, your doctor may recommend temporarily or permanently stopping treatment with Trexall. If you notice any symptoms of kidney problems, talk with your doctor right away.
Serious lung problems, including sudden and long-lasting interstitial pneumonitis, have been reported in people taking Trexall. This wasn’t a common side effect in the drug’s clinical trials. In rare cases, lung problems can lead to death.
interstitial
clinical trials
Symptoms of a lung problem may include:
shortness of breath, which may get worse over time
dry cough
unexplained weight loss
What you can do
If you develop any symptoms of lung problems, contact your doctor right away.
Serious skin reactions, including Stevens-Johnson syndrome, are possible during treatment with Trexall. In rare cases, these skin reactions can be fatal. However, this wasn’t commonly reported in the drug’s clinical trials.
Stevens-Johnson syndrome
clinical trials
Symptoms of a skin reaction may include:
skin discoloration
skin rash that blisters or peels
fever
body-aches
Your skin may also be more sensitive to the sun. You may be at an increased risk of sunburn or skin burn in areas previously exposed to radiation treatment.
What you can do
During treatment with Trexall, try to avoid being in the sun for long periods. Protect your skin by using sunscreen, wearing a hat, and wearing protective clothing.
If you experience any symptoms of a skin reaction, contact your doctor right away. They may have you temporarily or permanently stop taking Trexall.
Diarrhea, nausea, vomiting, and mouth sores were common side effects reported in Trexall’s clinical trials. In rare cases, Trexall can cause inflammation or a perforation (tear) in the intestine. This can cause severe bleeding, which may be fatal.
clinical trials
inflammation
perforation (tear)
Symptoms of a serious GI problem may include:
loss of appetite
severe abdominal pain
fever
bright red blood in your stools
blood in your stools
black tarry stools
The risk of serious digestive problems is higher in people who have ulcerative colitis (UC) or stomach ulcers (peptic ulcers).
ulcerative colitis (UC)
peptic ulcers
What you can do
If you have nausea, vomiting, diarrhea, or mouth sores that are bothersome or do not go away, talk with your doctor. They can determine whether it’s safe for you to continue taking Trexall.
Contact your doctor right away if you experience any symptoms of a serious GI problem.
Trexall can cause problems with certain blood cell counts. The most common is thrombocytopenia (low platelet count). But, Trexall can also cause leukopenia (low white blood cell count) or anemia (low red blood cell count). Typically, the effects are mild, but severe and life threatening changes in blood cell counts have occurred in clinical trials of Trexall.
thrombocytopenia
leukopenia
anemia
clinical trials
You may not notice any symptoms unless your levels are very low. The table below describes possible symptoms of these blood disorders.
petechiae
malaise
pale complexion
What you can do
Talk with your doctor about whether you’re up to date on all your vaccines before taking Trexall. You can help prevent infections by washing your hands often and avoiding crowds and people who are sick, if possible.
Your doctor will order blood tests before you start treatment and regularly monitor your blood counts. If they find a problem with your blood tests, they may decrease your dose or recommend that you stop taking Trexall.
Precautions for Trexall
Below is important information you should consider before taking Trexall.
Trexall has boxed warnings. A boxed warning is the most serious warning from the FDA. For details, see the “Side effect specifics” section.
boxed warnings
Side effect specifics
Before taking Trexall, discuss your health history with your doctor. Trexall may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
weakened immune system
liver problems
kidney problems
peptic ulcers
peptic ulcers
blood disorder
UC
have fluid in your stomach (ascites) or lungs (pleural effusion)
ascites
pleural effusion
alcohol consumption
previous allergic reaction to this or a similar drug
allergic reaction
pregnancy
breastfeeding
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.