Leflunomide Side Effects
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Leflunomide Safety Reports submitted to FDA
Total Leflunomide reports: 23.Leflunomide FDA safety alerts: 2003 .
Reported deaths: 2 Reported hospitalizations: 11.
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Reported Leflunomide Side Effects: pyrexia, myelodysplastic syndrome, leukopenia, diarrhoea, pregnancy of partner, transaminases increased, accidental overdose, accidental exposure, dyspnoea, condition aggravated, infection.
Leflunomide Usage.
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Leflunomide Side Effects Report #5205829-8
Consumer or non-health professional from UNITED STATES reported LEFLUNOMIDE problem on Jan 05, 2007. Female patient, 55 years of age, weighting 145.0 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: coagulopathy, haemorrhagic stroke, hepatic failure, hepatotoxicity, influenza like illness, liver disorder, lung disorder, no therapeutic response. LEFLUNOMIDE dosage: 10 MG DAILY PO. During the same period patient was treated with HUMIRA. Patient died on 11/23/2005.
Leflunomide Side Effects Report #5212784-3
LEFLUNOMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 18, 2007. Female patient, weighting 350.0 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: asthma, blister, pyrexia. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with LISINOPRIL, HYDROCHLOROTHIAZIDE, PREDNISONE, METFORMIN, ASPIRIN. Patient recovered.
Leflunomide Side Effects Report #5221842-9
Pharmacist from UNITED STATES reported LEFLUNOMIDE problem on Jan 25, 2007. Male patient, 76 years of age, weighting 162.0 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: epistaxis, faeces discoloured, fatigue, haemoglobin decreased, liver function test abnormal, nausea, pancytopenia, platelet count decreased. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5224957-4
LEFLUNOMIDE problem was reported by a Physician from FRANCE on June 30, 2005. Male patient, 30 years of age, was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: pregnancy of partner. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with NSAID. Patient recovered.
Leflunomide Side Effects Report #5236881-1
Consumer or non-health professional from reported LEFLUNOMIDE problem on Jan 31, 2007. Female patient, 40 years of age, was diagnosed with psoriatic arthropathy, arthralgia, dyspepsia and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: psoriasis. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with ACETAMINOPHEN AND CODEINE PHOSPHATE, IBUPROFEN, LANSOPRAZOLE. Patient recovered.
Leflunomide Side Effects Report #5247680-9
LEFLUNOMIDE problem was reported by a Consumer or non-health professional from on Feb 20, 2007. Female patient, 40 years of age, was diagnosed with dyspepsia and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: psoriasis. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with ACETAMINOPHEN W, IBUPROFEN, LANSOPRAZOLE. Patient recovered.
Leflunomide Side Effects Report #5262507-7
Consumer or non-health professional from reported LEFLUNOMIDE problem on Feb 27, 2007. Female patient, 24 years of age, weighting 123.2 lb, was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with ACECLOFENAC, CYCLOSPORINE. Patient recovered.
Leflunomide Side Effects Report #5277207-7
LEFLUNOMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 22, 2007. Male patient, 43 years of age, weighting 200.0 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: disease recurrence, rheumatoid arthritis. LEFLUNOMIDE dosage: 20MG DAILY PO. Patient recovered.
Leflunomide Side Effects Report #5301489-6
Health Professional from UNITED STATES reported LEFLUNOMIDE problem on Mar 28, 2007. Female patient, 35 years of age, weighting 242.1 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, pregnancy. LEFLUNOMIDE dosage: 20 MG, QD, ORAL. During the same period patient was treated with PRENATAL VITAMINS, PLAQUENIL, PREDNISONE, VICODIN, AMBIEN, SYTHROID, TYLENOL. Patient recovered.
Leflunomide Side Effects Report #5370254-6
LEFLUNOMIDE problem was reported by a Physician from UNITED STATES on June 25, 2007. Female patient, weighting 154.0 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident, coagulopathy, hepatic failure, nausea, pulmonary embolism, vomiting. LEFLUNOMIDE dosage: 10MG. During the same period patient was treated with HUMIRA. Patient died on 11/25/2006.
Leflunomide Side Effects Report #5063996-3
Consumer or non-health professional from UNITED STATES reported LEFLUNOMIDE problem on May 18, 2006. Female patient, 66 years of age, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: alopecia, anxiety, blood glucose increased, blood pressure increased, chest pain, constipation, coronary artery disease, diarrhoea, dizziness. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with ARAVA, ASPIRIN, PREDNISONE, HYZAAR, TOPROL, AMBIEN, LASIX, ESOMEPRAZOLE MAGNESIUM. Patient recovered.
Leflunomide Side Effects Report #5072222-0
LEFLUNOMIDE problem was reported by a Physician from AUSTRIA on July 26, 2006. Female patient was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: infection, leukopenia, myelodysplastic syndrome, pyrexia. LEFLUNOMIDE dosage: unknown. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5079193-1
Physician from AUSTRIA reported LEFLUNOMIDE problem on July 26, 2006. Female patient, 66 years of age, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: infection, leukopenia, mucosal inflammation, myelodysplastic syndrome, pyrexia, sepsis, thrombocytopenia. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with ATACAND HCT, THYREX, PANTOPRAZOLE. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5087328-X
LEFLUNOMIDE problem was reported by a Pharmacist from UNITED STATES on Aug 23, 2006. Female patient, 58 years of age, weighting 262.4 lb, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: angioneurotic oedema, asthma, condition aggravated, dyspnoea, urticaria. LEFLUNOMIDE dosage: 10 MG DAILY PO. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5141606-4
Pharmacist from UNITED STATES reported LEFLUNOMIDE problem on Oct 23, 2006. Female patient, 71 years of age, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, arrhythmia, arthralgia, arthritis, condition aggravated, diarrhoea, erythema, joint swelling. LEFLUNOMIDE dosage: 20 MG, QD, ORAL. During the same period patient was treated with ARAVA, LASIX, POTASSIUM CHLORIDE, PREDNISONE, PRILOSEC, CARDIZEM, SYNTRHOID, XOPENEX. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5154138-4
LEFLUNOMIDE problem was reported by a Consumer or non-health professional from on Apr 04, 2005. Male patient, 41 years of age, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: pregnancy of partner. LEFLUNOMIDE dosage: unknown. Patient recovered.
Leflunomide Side Effects Report #5193815-6
Consumer or non-health professional from reported LEFLUNOMIDE problem on Dec 19, 2006. Male patient, 66 years of age, was diagnosed with rheumatoid arthritis, anxiety, depression, hereditary spherocytosis, hypertension, pain and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, diarrhoea, gamma-glutamyltransferase increased, international normalised ratio increased, jaundice, liver function test abnormal, urine analysis abnormal. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with SULFASALAZINE, CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE, FOLIC ACID, KENALOG, LOSARTAN POTASSIUM, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5399322-X
LEFLUNOMIDE problem was reported by a Consumer or non-health professional from on July 23, 2007. Female patient, child 2 years of age, was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: accidental exposure, accidental overdose, transaminases increased. LEFLUNOMIDE dosage: unknown. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5402308-X
Consumer or non-health professional from UNITED KINGDOM reported LEFLUNOMIDE problem on July 23, 2007. Male patient, 69 years of age, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: alveolitis allergic, dyspnoea. LEFLUNOMIDE dosage: unknown. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5402312-1
LEFLUNOMIDE problem was reported by a Consumer or non-health professional from on July 25, 2007. Female patient, child 2 years of age, was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: accidental exposure, accidental overdose, transaminases increased. LEFLUNOMIDE dosage: unknown. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5409585-X
Consumer or non-health professional from reported LEFLUNOMIDE problem on Aug 01, 2007. Female patient, 68 years of age, weighting 146.2 lb, was diagnosed with rheumatoid arthritis, prophylaxis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: lung abscess, pulmonary embolism. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with HUMIRA, DOSULEPIN, FOSAMAX, OMEPRAZOLE, PARACETAMOL, PREDNISOLONE. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5447464-2
LEFLUNOMIDE problem was reported by a Physician from AUSTRIA on Aug 21, 2007. Female patient, 64 years of age, was diagnosed with rheumatoid arthritis and was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: bone marrow toxicity, leukopenia, lymphopenia, myelodysplastic syndrome, neutropenia, pyrexia, stomatitis. LEFLUNOMIDE dosage: 10 MG, 20 MG. During the same period patient was treated with METAMIZOLE. Patient was hospitalized. Patient recovered.
Leflunomide Side Effects Report #5451971-6
Physician from UNITED KINGDOM reported LEFLUNOMIDE problem on Sept 03, 2007. Male patient was treated with LEFLUNOMIDE. After drug was administered, patient experienced the following problems/side effects: cerebral palsy, multiple congenital abnormalities, muscle spasticity, premature baby. LEFLUNOMIDE dosage: unknown. During the same period patient was treated with CHOLESTYRAMINE RESIN. Patient recovered.
Drug Information: Leflunomide
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a600032.html
(le floo' na mide)IMPORTANT WARNING:
| Pregnant women and women of childbearing age who are not using a reliable method of birth control should not take leflunomide. Pregnancy must be avoided during treatment and for 2 years after treatment with leflunomide. If your period is late or you miss a period during treatment with leflunomide, call your doctor immediately. Talk to your doctor if you plan to become pregnant after stopping treatment with leflunomide. Your doctor can prescribe a treatment that will decrease the risk of harm to the fetus. |
Why is this medication prescribed?
Leflunomide is used to treat rheumatoid arthritis. Leflunomide decreases the symptoms of rheumatoid arthritis and slows damage to joints caused by the disease.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Leflunomide comes as a tablet to take by mouth. It is usually taken once a day. You will need to take a larger dose for the first 3 days of treatment. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take leflunomide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
What special precautions should I follow?
Before taking leflunomide,
- tell your doctor and pharmacist if you are allergic to leflunomide or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially cholestyramine (Cholybar, Questran), colestipol (Colestid), felbamate (Felbatol), mercaptopurine (Purinethol), rifampin (Rifadin, Rimactane, Rifater), methotrexate (Rheumatrex), tolbutamide (Orinase), troglitazone (Rezulin), and vitamins.
- tell your doctor if you have or have ever had liver or kidney disease, hepatitis, severe infections, or conditions affecting the bone marrow or the immune system (including human immunodeficiency virus [HIV] and acquired immunodeficiency syndrome [AIDS]).
- tell your doctor if you are breast-feeding.
- if you are planning to father a child, you should talk to your doctor about stopping leflunomide prior to conception.
- you should not receive any vaccinations while taking leflunomide unless you have talked with your doctor.
- you should know that there is a special treatment for removing leflunomide from your body once you stop taking it. Ask your doctor or pharmacist for more information about this treatment.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Leflunomide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- diarrhea
- hair loss
- headache
- dizziness
- upset stomach
- vomiting
- stomach pain
- loss of appetite
- weight loss
- mouth sores
- runny nose
- back pain
- dry or itchy skin
- muscle pain or weakness
- flu-like symptoms
- urinary tract infection
If you experience any of the following symptoms, call your doctor immediately:
- rash
- difficulty breathing
- chest pain
- increased heart rate
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor. Your doctor will order certain laboratory tests to monitor your response to leflunomide.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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