Tadalafil Safety Questions, Tadalafil Answers
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Tadalafil Safety Reports
Total Tadalafil reports: 30.Tadalafil FDA safety alerts: 2005 2007 .
Reported deaths: 4 Reported hospitalizations: 20.
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Reported Tadalafil Side Effects: urinary tract infection, hemiparesis, aphasia, hypersensitivity, epistaxis, testicular pain, oesophageal varices haemorrhage, histiocytosis haematophagic, atrial fibrillation, hepatitis acute, oedema.
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Tadalafil Side Effects Report #5197094-5
Physician from DENMARK reported TADALAFIL problem on Dec 21, 2006. Male patient, 74 years of age, weighting 158.7 lb, was diagnosed with erectile dysfunction, prostate cancer and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: aphasia, hemiparesis, high density lipoprotein abnormal, low density lipoprotein abnormal, urinary tract infection. TADALAFIL dosage: 10 MG, DAILY (1/D). During the same period patient was treated with CASODEX. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5219023-8
TADALAFIL problem was reported by a Physician from DENMARK on Jan 19, 2007. Male patient, 74 years of age, weighting 158.7 lb, was diagnosed with erectile dysfunction, prostate cancer and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: aphasia, hemiparesis, urinary tract infection. TADALAFIL dosage: 10 MG, DAILY (1/D). During the same period patient was treated with CASODEX. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5234754-1
Consumer or non-health professional from NETHERLANDS reported TADALAFIL problem on Jan 30, 2007. Male patient, 65 years of age, weighting 185.2 lb, was diagnosed with erectile dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage. TADALAFIL dosage: 10 MG,. During the same period patient was treated with METFORMIN, LIPITOR, LOSEC MUPS HP, GAVISCON. Patient was hospitalized and became disabled. Patient recovered.
Tadalafil Side Effects Report #5237834-X
TADALAFIL problem was reported by a Physician from NETHERLANDS on Jan 30, 2007. Male patient, 65 years of age, weighting 185.2 lb, was diagnosed with erectile dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, diabetes mellitus inadequate control, hypertension. TADALAFIL dosage: 10 MG,. During the same period patient was treated with METFORMIN, LIPITOR, LOSEC MUPS HP, GAVISCON. Patient was hospitalized and became disabled. Patient recovered.
Tadalafil Side Effects Report #5241742-8
Consumer or non-health professional from NORWAY reported TADALAFIL problem on Feb 09, 2007. Male patient was diagnosed with erectile dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: non-cardiac chest pain, odynophagia. TADALAFIL dosage: 20 MG, AS NEEDED. Patient recovered.
Tadalafil Side Effects Report #5247683-4
TADALAFIL problem was reported by a Physician from on Feb 19, 2007. Male patient, 53 years of age, was diagnosed with erectile dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, oedema. TADALAFIL dosage: unknown. Patient died on 11/23/2003.
Tadalafil Side Effects Report #5247705-0
Physician from reported TADALAFIL problem on Feb 19, 2007. Male patient, 46 years of age, was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: hepatitis acute. TADALAFIL dosage: unknown. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5253087-0
TADALAFIL problem was reported by a Physician from UNITED STATES on Feb 16, 2007. Female patient, 61 years of age, weighting 151.0 lb, was diagnosed with pulmonary hypertension, anaemia, depression, diarrhoea, chronic obstructive pulmonary disease, hypothyroidism and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: anaesthetic complication. TADALAFIL dosage: 40 MG, UNK. During the same period patient was treated with HYDROCHLOROTHIAZIDE, KLONOPIN, LOMOTIL, CALCIUM WITH VITAMIN D, SPIRIVA, SYNTHROID. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5293635-8
Physician from GREECE reported TADALAFIL problem on Mar 29, 2007. Male patient, 63 years of age, was diagnosed with erectile dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: gastric haemorrhage. TADALAFIL dosage: 20 MG, AS NEEDED. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5306288-7
TADALAFIL problem was reported by a Consumer or non-health professional from HUNGARY on Apr 10, 2007. Male patient, 47 years of age, was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: cataract, visual acuity reduced. TADALAFIL dosage: 10 MG, AS NEEDED. Patient recovered.
Tadalafil Side Effects Report #5330841-8
Physician from PORTUGAL reported TADALAFIL problem on May 10, 2007. Male patient, 57 years of age, was diagnosed with erectile dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation. TADALAFIL dosage: unknown. Patient recovered.
Tadalafil Side Effects Report #5346383-X
TADALAFIL problem was reported by a Physician from JAPAN on May 25, 2007. Female patient, 28 years of age, weighting 126.5 lb, was diagnosed with pulmonary hypertension, gastritis prophylaxis, osteoporosis, hyperlipidaemia, systemic lupus erythematosus and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: histiocytosis haematophagic, thrombotic thrombocytopenic purpura. TADALAFIL dosage: 20 MG, EACH MORNING. During the same period patient was treated with PROCYLIN, SELBEX, WARFARIN POTASSIUM, ONEALFA, MEVALOTIN, BONALON, PREDONINE, PREDNISOLONE. Patient died on 03/03/2007.
Tadalafil Side Effects Report #5346391-9
Physician from JAPAN reported TADALAFIL problem on May 28, 2007. Female patient, 43 years of age, weighting 119.0 lb, was diagnosed with pulmonary hypertension, systemic lupus erythematosus, autoimmune thyroiditis, right ventricular failure and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: oesophageal varices haemorrhage. TADALAFIL dosage: 10 MG, DAILY (1/D). During the same period patient was treated with PREDNISOLONE, WARFARIN, THYRADIN S, DIART, ALDACTONE. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5362216-X
TADALAFIL problem was reported by a Physician from JAPAN on June 07, 2007. Female patient, 43 years of age, weighting 116.8 lb, was diagnosed with pulmonary hypertension, systemic lupus erythematosus, autoimmune thyroiditis, right ventricular failure and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: oesophageal varices haemorrhage. TADALAFIL dosage: 10 MG, DAILY (1/D). During the same period patient was treated with PREDNISOLONE, WARFARIN, THYRADIN S, THYRADIN S, DIART, ALDACTONE. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5065614-7
Consumer or non-health professional from GREECE reported TADALAFIL problem on July 06, 2006. Male patient, 19 years of age, weighting 154.3 lb, was diagnosed with sexual dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: hypersensitivity, testicular pain. TADALAFIL dosage: 20 MG, DAILY (1/D); ORAL. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5086966-8
TADALAFIL problem was reported by a Physician from GREECE on July 31, 2006. Male patient, 19 years of age, weighting 154.3 lb, was diagnosed with sexual dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: chills, hypersensitivity, pruritus, pyrexia, rash, testicular pain, unevaluable event. TADALAFIL dosage: 20 MG, DAILY (1/D), ORAL. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5113746-7
Pharmacist from UNITED STATES reported TADALAFIL problem on Sept 21, 2006. Male patient was diagnosed with erectile dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: anxiety, asthenia, dizziness, feeling abnormal, heart rate increased, hyperhidrosis, incorrect dose administered, respiratory rate increased. TADALAFIL dosage: 20 MG PO DAILY PRN. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5113934-X
TADALAFIL problem was reported by a Consumer or non-health professional from GREECE on Sept 04, 2006. Male patient, 19 years of age, weighting 154.3 lb, was diagnosed with sexual dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: hypersensitivity, somatoform disorder. TADALAFIL dosage: 20 MG, DAILY (1/D), ORAL. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5126785-7
Consumer or non-health professional from UNITED STATES reported TADALAFIL problem on Oct 11, 2006. Male patient, 64 years of age, weighting 167.0 lb, was diagnosed with erectile dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: diarrhoea, flatulence, gastrointestinal disorder. TADALAFIL dosage: unknown. Patient recovered.
Tadalafil Side Effects Report #5164695-X
TADALAFIL problem was reported by a Physician from DENMARK on Nov 24, 2006. Male patient, 75 years of age, weighting 158.7 lb, was diagnosed with erectile dysfunction, prostate cancer and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: aphasia, hemiparesis, urinary tract infection. TADALAFIL dosage: 10 MG, DAILY (1/D). During the same period patient was treated with CASODEX. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5188584-X
Physician from DENMARK reported TADALAFIL problem on Nov 24, 2006. Male patient, 74 years of age, weighting 158.7 lb, was diagnosed with erectile dysfunction, prostate cancer and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: aphasia, hemiparesis, urinary tract infection. TADALAFIL dosage: 10 MG, DAILY (1/D). During the same period patient was treated with CASODEX. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5383690-9
TADALAFIL problem was reported by a Physician from JAPAN on June 26, 2007. Female patient, 38 years of age, weighting 112.4 lb, was diagnosed with pulmonary hypertension, iron deficiency anaemia and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: menorrhagia. TADALAFIL dosage: 20 MG, DAILY (1/D). During the same period patient was treated with TRACLEER, DORNER, WARFARIN, FERROUS CITRATE. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5388373-7
Physician from PORTUGAL reported TADALAFIL problem on July 06, 2007. Male patient, 57 years of age, was diagnosed with erectile dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation. TADALAFIL dosage: unknown. Patient recovered.
Tadalafil Side Effects Report #5395649-6
TADALAFIL problem was reported by a Physician from UNITED KINGDOM on July 10, 2007. Female patient, 63 years of age, weighting 286.6 lb, was diagnosed with pulmonary hypertension, depressed mood, prophylaxis and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: epistaxis, nasal congestion. TADALAFIL dosage: unknown. During the same period patient was treated with FUROSEMIDE, ENALAPRIL MALEATE, CETRIZINE, PRAVASTATIN, WARFARIN. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5396167-1
Physician from UNITED KINGDOM reported TADALAFIL problem on July 10, 2007. Female patient, 63 years of age, weighting 286.6 lb, was diagnosed with pulmonary hypertension, depressed mood, prophylaxis and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: epistaxis. TADALAFIL dosage: unknown. During the same period patient was treated with FUROSEMIDE, ENALAPRIL MALEATE, CETRIZINE, PRAVASTATIN, WARFARIN. Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5403042-2
TADALAFIL problem was reported by a Physician from JAPAN on July 20, 2007. Female patient, 28 years of age, weighting 126.5 lb, was diagnosed with pulmonary hypertension, gastritis prophylaxis, osteoporosis, hyperlipidaemia, systemic lupus erythematosus and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, haemorrhagic diathesis, histiocytosis haematophagic, infection, pleural effusion, pulmonary alveolar haemorrhage. TADALAFIL dosage: 20 MG, EACH MORNING. During the same period patient was treated with PROCYLIN, SELBEX, WARFARIN POTASSIUM, ONEALFA, MEVALOTIN, BONALON, PREDNISOLONE. Patient died on 03/03/2007.
Tadalafil Side Effects Report #5427435-2
Physician from reported TADALAFIL problem on Aug 17, 2007. Male patient, 53 years of age, was diagnosed with erectile dysfunction and was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, cardiac arrest, oedema. TADALAFIL dosage: unknown. Patient died on 11/23/2003.
Tadalafil Side Effects Report #5427442-X
TADALAFIL problem was reported by a Physician from on Aug 17, 2007. Male patient, 46 years of age, was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: hepatitis acute. TADALAFIL dosage: 10 MG, WEEKLY (1/W). Patient was hospitalized. Patient recovered.
Tadalafil Side Effects Report #5463353-1
Physician from GREECE reported TADALAFIL problem on Sept 13, 2007. Male patient, 60 years of age, was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: myalgia, restlessness. TADALAFIL dosage: 20 MG, DAILY (1/D). Patient recovered.
Tadalafil Side Effects Report #5469873-8
TADALAFIL problem was reported by a Physician from SWEDEN on Sept 14, 2007. Male patient, 66 years of age, was treated with TADALAFIL. After drug was administered, patient experienced the following problems/side effects: cardiac disorder. TADALAFIL dosage: 20 MG, UNK. Patient was hospitalized. Patient recovered.
Drug Information: Tadalafil
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a604008.html
(tah da' la fil)Why is this medication prescribed?
Tadalafil is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Tadalafil is in a class of medications called phosphodiesterase (PDE) inhibitors. It works by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Tadalafil does not cure erectile dysfunction or increase sexual desire. Tadalafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).
How should this medicine be used?
Tadalafil comes as a tablet to take by mouth. It is usually taken with or without food before sexual activity. Your doctor will help you decide the best time for you to take tadalafil before sexual activity. Tadalafil should not be taken more often than once every 24 hours. If you have certain health conditions or are taking certain medications, your doctor may tell you to take tadalafil less often. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tadalafil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on an average dose of tadalafil and increase or decrease your dose depending on your response to the medication. Tell your doctor if tadalafil is not working well or if you are experiencing side effects.
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 tadalafil,
- tell your doctor and pharmacist if you are allergic to tadalafil or any other medications.
- do not take tadalafil if you are taking or have recently taken nitrates such as isosorbide dinitrate (Isordil), isosorbide mononitrate (Imdur, ISMO), and nitroglycerin (Nitro-BID, Nitro-Dur, Nitroquick, Nitrostat, others). Nitrates come as tablets, sublingual (under the tongue) tablets, sprays, patches, pastes, and ointments. Ask your doctor if you are not sure whether any of your medications contain nitrates.
- do not take street drugs containing nitrates such as amyl nitrate and butyl nitrate ('poppers') while taking tadalafil.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax), and terazosin (Hytrin); amiodarone (Cordarone, Pacerone); certain antifungals such as fluconazole (Diflucan), griseofulvin (Fulvicin, Grifulvin, Gris-PEG), itraconazole (Sporanox), ketoconazole (Nizoral), voriconazole (Vfend); aprepitant (Emend);carbamazepine (Tegretol); cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); dexamethasone (Decadron); diltiazem (Cardizem, Dilacor, Tiazac); efavirenz (Sustiva);erythromycin (E.E.S., E-Mycin, Erythrocin); ethosuximide (Zarontin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra),nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); isoniazid (INH, Nydrazid); lovastatin (Altocor, Mevacor); medications for high blood pressure; metronidazole (Flagyl); nefazodone (Serzone); nevirapine (Viramune); other medications or treatments for erectile dysfunction; phenobarbital; phenytoin (Dilantin); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); sertraline (Zoloft); 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 what herbal products you are taking, especially St. John's wort.
- tell your doctor if you smoke and if you have ever had an erection that lasted more than 4 hours. Also tell your doctor if you have or have ever had a condition that affects the shape of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease; diabetes; high cholesterol; high or low blood pressure; irregular heartbeat; a heart attack; angina (chest pain); a stroke; ulcers in the stomach or intestine; a bleeding disorder; blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); and liver, kidney, or heart disease. Also tell your doctor if you or any of your family members have or have ever had an eye disease such as retinitis pigmentosa or if you have ever had severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see. Tell your doctor if you have ever been advised by a health care professional to avoid sexual activity for medical reasons or if you have ever experienced chest pain during sexual activity.
- you should know that tadalafil is only for use in males. Women should not take tadalafil, especially if they are or could become pregnant or are breast-feeding. If a pregnant woman takes tadalafil, she should call her doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tadalafil.
- ask your doctor about the safe use of alcoholic beverages while you are taking tadalafil. Alcohol can make the side effects from tadalafil worse. Your doctor will tell you how much alcohol you may drink while you are taking this medication.
- you should know that sexual activity may be a strain on your heart, especially if you have heart disease. If you have chest pain during sexual activity, call your doctor immediately and avoid sexual activity until your doctor tells you otherwise.
- tell all your health care providers that you are taking tadalafil. If you ever need emergency medical treatment for a heart problem, the health care providers who treat you will need to know when you last took tadalafil.
What special dietary instructions should I follow?
Talk to your doctor about drinking grapefruit juice while taking this medicine.
What side effects can this medication cause?
Tadalafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- indigestion or heartburn
- flushing
- pain in the back, muscles, or any limb
- stuffy or runny nose
If you experience any of the following symptoms , call your doctor immediately:
- sudden severe loss of vision (see below for more information)
- blurred vision
- changes in color vision (seeing a blue tinge on objects or having difficulty telling the difference between blue and green)
- sudden decrease or loss of hearing
- ringing in ears
- erection that lasts longer than 4 hours
- dizziness
- chest pain
- hives
- rash
Tadalafil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
Some patients experienced a sudden loss of some or all of their vision after they took tadalafil or other medications that are similar to tadalafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking tadalafil, call your doctor immediately. Do not take any more doses of tadalafil or similar medications such as sildenafil (Viagra) or vardenafil (Levitra) until you talk to your doctor.
Some patients experienced a sudden decrease or loss of hearing after they took tadalafil or other medications that are similar to tadalafil. The hearing loss usually involved only one ear and may not get better. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking tadalafil, call your doctor immediately. Do not take any more doses of tadalafil or similar medications such as sildenafil (Viagra) or vardenafil (Levitra) until you talk to your doctor.
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.
Symptoms of overdose may include:
- headache
- indigestion or heartburn
- flushing
- pain in the back, muscles, or any limb
- stuffy or runny nose
- erection that lasts longer than 4 hours
What other information should I know?
Keep all appointments with your doctor.
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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