Dutasteride Side Effects
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Dutasteride Safety Reports reported to FDA
Total Dutasteride reports: 61.Dutasteride FDA safety alerts: No.
Reported deaths: 7 Reported hospitalizations: 41.
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Reported Dutasteride Side Effects: chest pain, dyspnoea, pulmonary oedema, coronary artery disease, oedema peripheral, cough, abdominal pain upper, dyspnoea exertional, abdominal pain, pulmonary embolism, asthenia.
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Dutasteride Side Effects Report #5164730-9Physician from UNITED STATES reported DUTASTERIDE problem on Nov 30, 2006. Male patient, 80 years of age, weighting 172.8 lb, was diagnosed with prostate cancer and was treated with DUTASTERIDE. After drug was administered, patient experienced the following problems/side effects: confusional state, hepatic enzyme increased, liver function test abnormal, speech disorder. DUTASTERIDE dosage: .5MG PER DAY. During the same period patient was treated with KETOCONAZOLE, HYDROCORTISONE, COUMADIN, ATENOLOL, LANOXIN, FLOMAX. Patient was hospitalized. Patient recovered.
Dutasteride Side Effects Report #5177053-9
DUTASTERIDE problem was reported by a Physician from NEW ZEALAND on Dec 06, 2006. Male patient, 75 years of age, weighting 202.8 lb, was diagnosed with neoplasm prophylaxis and was treated with DUTASTERIDE. After drug was administered, patient experienced the following problems/side effects: metastases to kidney. DUTASTERIDE dosage: unknown. Patient recovered.
Dutasteride Side Effects Report #5179334-1
Physician from GERMANY reported DUTASTERIDE problem on Mar 28, 2006. Male patient, 73 years of age, weighting 152.1 lb, was diagnosed with neoplasm prophylaxis and was treated with DUTASTERIDE. After drug was administered, patient experienced the following problems/side effects: aortic aneurysm, arrhythmia. DUTASTERIDE dosage: .5MG PER DAY. Patient was hospitalized. Patient died on 03/26/2006.
Dutasteride Side Effects Report #5193762-X
DUTASTERIDE problem was reported by a Physician from ISRAEL on Dec 18, 2006. Male patient, 68 years of age, weighting 165.3 lb, was diagnosed with benign prostatic hyperplasia and was treated with DUTASTERIDE. After drug was administered, patient experienced the following problems/side effects: back pain, dysstasia, muscular weakness, paresis. DUTASTERIDE dosage: .5MG PER DAY. During the same period patient was treated with TAMSULOSIN. Patient recovered.
Dutasteride Side Effects Report #5384205-1
Physician from SOUTH AFRICA reported DUTASTERIDE problem on July 04, 2007. Male patient, weighting 176.4 lb, was diagnosed with benign prostatic hyperplasia and was treated with DUTASTERIDE. After drug was administered, patient experienced the following problems/side effects: colon cancer. DUTASTERIDE dosage: .5MG PER DAY. During the same period patient was treated with ZELNORM. Patient was hospitalized. Patient recovered.
Dutasteride Side Effects Report #5385536-1
DUTASTERIDE problem was reported by a Physician from NETHERLANDS on July 05, 2007. Male patient, 63 years of age, weighting 229.3 lb, was treated with DUTASTERIDE. After drug was administered, patient experienced the following problems/side effects: gastritis haemorrhagic. DUTASTERIDE dosage: .5MG PER DAY. During the same period patient was treated with AMITRIPTYLINE, SIMVASTATIN, PIPAMPERON. Patient recovered.
Dutasteride Side Effects Report #5386567-8
Physician from GERMANY reported DUTASTERIDE problem on July 05, 2007. Male patient, 59 years of age, weighting 200.6 lb, was diagnosed with benign prostatic hyperplasia and was treated with DUTASTERIDE. After drug was administered, patient experienced the following problems/side effects: chest pain, coronary artery stenosis, nasopharyngitis, stent placement. DUTASTERIDE dosage: unknown. Patient was hospitalized. Patient recovered.
Dutasteride Side Effects Report #5396646-7
DUTASTERIDE problem was reported by a Physician from NORWAY on July 19, 2007. Male patient, 63 years of age, weighting 149.9 lb, was diagnosed with neoplasm prophylaxis and was treated with DUTASTERIDE. After drug was administered, patient experienced the following problems/side effects: chest pain, dyspnoea, metastases to liver, non-small cell lung cancer. DUTASTERIDE dosage: .5MG PER DAY. Patient was hospitalized and became disabled. Patient recovered.
Dutasteride Side Effects Report #5465740-4
Physician from UNITED STATES reported DUTASTERIDE problem on Sept 19, 2007. Male patient, 70 years of age, weighting 188.5 lb, was diagnosed with prostate cancer, hypertension and was treated with DUTASTERIDE. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, pulmonary embolism. DUTASTERIDE dosage: .5MG PER DAY. During the same period patient was treated with KETOCONAZOLE, HYDROCORTISONE, EXTRA STRENGTH ASA, LISINOPRIL. Patient recovered.
Dutasteride Side Effects Report #5469483-2
DUTASTERIDE problem was reported by a Physician from UNITED STATES on Sept 25, 2007. Male patient, 70 years of age, weighting 188.5 lb, was diagnosed with prostate cancer, hypertension and was treated with DUTASTERIDE. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, pulmonary embolism. DUTASTERIDE dosage: .5MG PER DAY. During the same period patient was treated with KETOCONAZOLE, HYDROCORTISONE, EXTRA STRENGTH ASA, LISINOPRIL. Patient recovered.
Dutasteride Side Effects Report #5470981-6
Physician from UNITED STATES reported DUTASTERIDE problem on Sept 24, 2007. Male patient, 70 years of age, weighting 164.2 lb, was diagnosed with neoplasm prophylaxis, anxiety, neuropathy and was treated with DUTASTERIDE. After drug was administered, patient experienced the following problems/side effects: syncope. DUTASTERIDE dosage: .5MG PER DAY. During the same period patient was treated with XANAX, LYRICA. Patient was hospitalized. Patient recovered.
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Drug Information: Dutasteride
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a603001.html
doo tas' teer ideWhy is this medication prescribed?
Dutasteride is used to treat an enlarged prostate (benign prostatic hyperplasia, or BPH). Dutasteride is in a class of medications called 5-alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate. This shrinks the prostate, relieves symptoms of BPH, such as frequent and difficult urination, and decreases the chance that surgery will be needed to treat this condition.
How should this medicine be used?
Dutasteride comes as a capsule to take by mouth. It is usually taken once a day with or without food. To help you remember to take dutasteride, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dutasteride exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole; do not split, chew, or crush them.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking dutasteride,
- tell your doctor and pharmacist if you are allergic to dutasteride, finasteride (Propecia, Proscar), or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as fluconazole, (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); ciprofloxacin (Cipro); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); isoniazid (INH, Nydrazid); metronidazole (Flagyl); nefazodone (Serzone); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had liver disease or prostate cancer.
- you should know that dutasteride is for use only in men. Women, especially those who are or may become pregnant, should not handle dutasteride capsules. Touching the contents of the capsules may harm the fetus. Women who accidentally touch leaking capsules should wash the area with soap and water immediately.
- you should know that you should not donate blood while you are taking dutasteride and for 6 months after you stop taking this medication.
What special dietary instructions should I follow?
Talk to your doctor about drinking grapefruit juice while taking this medicine.
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 the 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?
Dutasteride may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- inability to have or maintain an erection
- decrease in sex drive
- difficulty ejaculating
- breast tenderness or enlargement
Dutasteride may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
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 and the laboratory. Your doctor will order certain lab tests to check your body's response to dutasteride.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking dutasteride.
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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