Pletal Safety Reports submitted to FDA
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More Rx Information: A B C D E F G H I J K L M N O P Q R S T U V W X Y ZTotal Pletal reports: 9.
Pletal FDA safety alerts: No.
Reported hospitalizations: 1.
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FDA Reported Pletal Side Effects: nervousness, hypoaesthesia, condition aggravated, upper gastrointestinal haemorrhage, shock haemorrhagic, gastric mucosal lesion, cytomegalovirus infection, oedema peripheral, neck pain, thrombocytopenia, tachycardia.
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Pletal Side Effects Report #5195805-6
Consumer or non-health professional from JAPAN reported PLETAL problem on Dec 21, 2006. Male patient, 72 years of age, was diagnosed with diabetes mellitus, angina pectoris, interstitial lung disease, rheumatoid arthritis and was treated with PLETAL. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus infection, gastric mucosal lesion, shock haemorrhagic, upper gastrointestinal haemorrhage. PLETAL dosage: unknown. During the same period patient was treated with ASPIRIN, PREDNISOLONE, DICLOFENAC. Patient recovered.
Pletal Side Effects Report #5218777-4
PLETAL problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 10, 2007. Female patient was treated with PLETAL. After drug was administered, patient experienced the following problems/side effects: tachycardia. PLETAL dosage: unknown. Patient recovered.
Pletal Side Effects Report #5243034-X
Physician from JAPAN reported PLETAL problem on Feb 13, 2007. Male patient, weighting 143.3 lb, was diagnosed with hypertension, hemiplegia and was treated with PLETAL. After drug was administered, patient experienced the following problems/side effects: nervousness. PLETAL dosage: unknown. During the same period patient was treated with BLOPRESS, PLAVIX. Patient recovered.
Pletal Side Effects Report #5268549-X
PLETAL problem was reported by a Pharmacist from UNITED STATES on Mar 15, 2007. Male patient, 91 years of age, weighting 195.0 lb, was diagnosed with arrhythmia and was treated with PLETAL. After drug was administered, patient experienced the following problems/side effects: thrombocytopenia. PLETAL dosage: 100 MG BID PO GREATER THAN 2 DAYS. During the same period patient was treated with GABAPENTIN, AVAPRO, FUROSEMIDE, LEVAQUIN, GLIPIZIDE, TYLENOL. Patient was hospitalized and became disabled. Patient recovered.
Pletal Side Effects Report #5288738-8
Physician from JAPAN reported PLETAL problem on Mar 27, 2007. Male patient, weighting 143.3 lb, was diagnosed with hemiplegia, hypertension and was treated with PLETAL. After drug was administered, patient experienced the following problems/side effects: condition aggravated, hypoaesthesia, nervousness. PLETAL dosage: unknown. During the same period patient was treated with PLAVIX, BLOPRESS. Patient recovered.
Pletal Side Effects Report #5291987-6
PLETAL problem was reported by a Pharmacist from UNITED STATES on Apr 06, 2007. Male patient, 90 years of age, was treated with PLETAL. After drug was administered, patient experienced the following problems/side effects: neck pain. PLETAL dosage: 100MG PO BID. During the same period patient was treated with ATACAND, NORVASC, ADVAIR DISKUS. Patient recovered.
Pletal Side Effects Report #5122987-4
Health Professional from UNITED STATES reported PLETAL problem on Oct 04, 2006. Male patient, 80 years of age, weighting 168.0 lb, was diagnosed with peripheral vascular disorder and was treated with PLETAL. After drug was administered, patient experienced the following problems/side effects: oedema peripheral. PLETAL dosage: 100 MG TWICE A DAY ORAL. During the same period patient was treated with ADVIL. Patient recovered.
Pletal Side Effects Report #5187899-9
PLETAL problem was reported by a Consumer or non-health professional from JAPAN on Dec 13, 2006. Male patient, 72 years of age, was diagnosed with diabetes mellitus, angina pectoris, interstitial lung disease, rheumatoid arthritis and was treated with PLETAL. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus infection, gastric mucosal lesion, shock haemorrhagic, upper gastrointestinal haemorrhage. PLETAL dosage: unknown. During the same period patient was treated with ASPIRIN, PREDNISOLONE, DICLOFENAC. Patient recovered.
Pletal Side Effects Report #5417221-1
Physician from JAPAN reported PLETAL problem on Aug 07, 2007. Male patient, weighting 143.3 lb, was diagnosed with hemiplegia, hypertension and was treated with PLETAL. After drug was administered, patient experienced the following problems/side effects: condition aggravated, hypoaesthesia, nervousness. PLETAL dosage: unknown. During the same period patient was treated with PLAVIX, CANDESARTAN CILEXETIL. Patient recovered.
Drug Information: Cilostazol
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601038.html
(sil oh' sta zol)IMPORTANT WARNING:
| Cilostazol should not be used by patients with congestive heart failure. If you have a history of heart disease, talk to your doctor about the potential risks associated with cilostazol before taking it. |
Why is this medication prescribed?
Cilostazol is used to reduce the symptoms of intermittent claudication (pain in the legs that happens when walking and goes away with rest). Cilostazol helps people walk a longer distance before leg pain starts.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Cilostazol comes as a tablet to take by mouth. It is usually taken two times a day. It should be taken at least 30 minutes before or 2 hours after breakfast and dinner. Follow the directions on the prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cilostazol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Cilostazol controls the symptoms of intermittent claudication but does not cure it. It may take up to 12 weeks before you notice a benefit (increased walking distance) from cilostazol. Continue taking cilostazol even if you feel well. Do not stop taking cilostazol without talking to your doctor.
What special precautions should I follow?
Before taking cilostazol,
- tell your doctor and pharmacist if you are allergic to cilostazol or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially aspirin, azithromycin (Zithromax), citalopram (Celexa), clarithromycin (Biaxin), clopidogrel (Plavix), diltiazem (Cardizem, Dilacor XR), erythromycin (E-mycin, Ery-Tab, others), fluconazole (Diflucan), fluoxetine (Prozac), fluvoxamine (Luvox), itraconazole (Sporanox), ketoconazole (Nizoral), nefazadone (Serzone), omeprazole (Prilosec), sertraline (Zoloft), warfarin (Coumadin), and vitamins.
- tell your doctor if you have or have ever had heart or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking cilostazol, call your doctor.
- tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of cilostazol.
What special dietary instructions should I follow?
You should not drink grapefruit juice while taking cilostazol.
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?
Cilostazol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- fast or irregular heartbeats
- diarrhea
- dizziness
- upset stomach
- stomach pain
- abnormal stools
- runny nose
- sore throat
- flu-like symptoms
If you experience any of the following symptoms, call your doctor immediately:
- rash
- swelling of the hands, feet, ankles, or lower legs
- shortness of breath
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.You should read the patient information that comes with your prescription before you begin to take cilostazol and read it again every time you have your prescription filled in case the patient information changes.
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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