Prezista Side Effects
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Prezista Safety Reports reported to FDA
Total Prezista reports: 95.Prezista FDA safety alerts: 2008 .
Reported deaths: 11 Reported hospitalizations: 68.
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Reported Prezista Side Effects: anaemia, renal failure acute, pyrexia, liver function test abnormal, immune reconstitution syndrome, hepatitis, aspartate aminotransferase increased, diarrhoea, rash maculo-papular, confusional state, chest pain.
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Showing 1-50 of 95 Next >
Prezista Side Effects Report #5368549-5Physician from UNITED STATES reported PREZISTA problem on June 14, 2007. Female patient, weighting 176.0 lb, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, bilirubin conjugated increased, blood uric acid increased, increased upper airway secretion, protein total increased, upper respiratory tract infection. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, TRUVADA, REYATAZ, ATRIPLA, IBUPROFEN, KEFLEX. Patient recovered.
Prezista Side Effects Report #5371824-1
PREZISTA problem was reported by a Physician from UNITED STATES on June 21, 2007. Female patient, weighting 175.0 lb, was diagnosed with hiv infection, diabetes mellitus, hypertension and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. PREZISTA dosage: unknown. During the same period patient was treated with EPZICOM, RITONAVIR, VALTREX, GLUCOPHAGE, METOPROLOL TARTRATE, CLARINEX. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5371828-9
Physician from UNITED KINGDOM reported PREZISTA problem on June 15, 2007. Male patient, weighting 149.9 lb, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, blood pressure decreased, pneumothorax, renal failure acute. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, LAMIVUDINE, DIDANOSINE, TRUVADA. Patient was hospitalized. Patient died on 04/30/2007.
Prezista Side Effects Report #5093752-1
PREZISTA problem was reported by a Physician from UNITED STATES on Aug 19, 2006. Male patient, 48 years of age, was diagnosed with hiv infection, ascites and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: cardiac failure congestive, clostridial infection, renal failure acute. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, VIREAD, EPZICOM, FUZEON, LASIX. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5107839-8
Pharmacist from UNITED STATES reported PREZISTA problem on Sept 08, 2006. Female patient was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. PREZISTA dosage: unknown. Patient recovered.
Prezista Side Effects Report #5110957-1
PREZISTA problem was reported by a Physician from UNITED STATES on Sept 11, 2006. Male patient, 57 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, dizziness, dizziness postural. PREZISTA dosage: unknown. During the same period patient was treated with NORVIR. Patient recovered.
Prezista Side Effects Report #5126626-8
Physician from UNITED STATES reported PREZISTA problem on Oct 02, 2006. Male patient, 57 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: dizziness. PREZISTA dosage: unknown. During the same period patient was treated with NORVIR. Patient recovered.
Prezista Side Effects Report #5147618-9
PREZISTA problem was reported by a Health Professional from UNITED STATES on Oct 31, 2006. Male patient, 21 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: hepatic enzyme increased. PREZISTA dosage: unknown. Patient recovered.
Prezista Side Effects Report #5163131-7
Physician from UNITED STATES reported PREZISTA problem on Nov 22, 2006. Male patient, 60 years of age, was diagnosed with hiv infection, blood uric acid, lipids, dyspepsia, infection prophylaxis and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: bile duct obstruction, liver function test abnormal, myositis. PREZISTA dosage: unknown. During the same period patient was treated with COLCHICINE, RITONAVIR, FLUVASTATIN, TRUVADA, OMEPRAZOLE, TRIMETHOPRIM, METOPROLOL SUCCINATE, SYNTHROID. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5190137-4
PREZISTA problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 15, 2006. Male patient, weighting 130.0 lb, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: squamous cell carcinoma. PREZISTA dosage: unknown. During the same period patient was treated with NORVIR, FUZEON, TRUVADA. Patient recovered.
Prezista Side Effects Report #5375945-9
Physician from UNITED STATES reported PREZISTA problem on June 27, 2007. Male patient, 46 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: cardiac arrest. PREZISTA dosage: unknown. During the same period patient was treated with TRUVADA, LASIX, BACTRIM, ANDROGEL. Patient died on 06/15/2007.
Prezista Side Effects Report #5378178-5
PREZISTA problem was reported by a Physician from UNITED STATES on June 27, 2007. Female patient, weighting 176.0 lb, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, TRUVADA, REYATAZ, ATRIPLA, IBUPROFEN, KEFLEX. Patient recovered.
Prezista Side Effects Report #5385230-7
Health Professional from UNITED STATES reported PREZISTA problem on June 29, 2007. Male patient, weighting 187.4 lb, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: chest pain, dyspnoea, haemoptysis, respiratory arrest. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, RALTEGRAVIR POTASSIUM, LAMIVUDINE. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5386412-0
PREZISTA problem was reported by a Physician from UNITED STATES on July 02, 2007. Female patient, weighting 120.0 lb, was diagnosed with hiv infection, antifungal prophylaxis, depression, anorexia, rash and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: meningitis aseptic, rash. PREZISTA dosage: unknown. During the same period patient was treated with NORVIR, TRUVADA, SULFAMETHOXAZOLE TM, SERTRALINE HYDROCHLORIDE, MARINOL, LOTRIMIN, HYDROCORTISONE. Patient recovered.
Prezista Side Effects Report #5390334-9
Physician from UNITED STATES reported PREZISTA problem on July 11, 2007. Female patient, weighting 176.0 lb, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, ETRAVIRINE, TRUVADA, REYATAZ, ATRIPLA, IBUPROFEN, KEFLEX. Patient recovered.
Prezista Side Effects Report #5392261-X
PREZISTA problem was reported by a Health Professional from UNITED STATES on Mar 23, 2007. Male patient, 21 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: pneumonia. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, EPZICOM, ENFUVIRTIDE. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5393323-3
Physician from UNITED STATES reported PREZISTA problem on July 10, 2007. Male patient, 47 years of age, weighting 126.0 lb, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: immune reconstitution syndrome. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, TRUVADA, AZITHROMYCIN. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5402243-7
PREZISTA problem was reported by a Physician from UNITED STATES on July 20, 2007. Male patient, 45 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: injury, subdural haematoma. PREZISTA dosage: unknown. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5403710-2
Physician from UNITED STATES reported PREZISTA problem on July 19, 2007. Male patient, 49 years of age, was diagnosed with hiv infection, rhinitis allergic and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: hepatitis. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, TRUVADA, LEVITRA, NASAREL. Patient recovered.
Prezista Side Effects Report #5404104-6
PREZISTA problem was reported by a Physician from UNITED STATES on July 19, 2007. Male patient, 49 years of age, was diagnosed with hiv infection, rhinitis allergic and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: hepatitis. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, TRUVADA, LEVITRA, NASAREL. Patient recovered.
Prezista Side Effects Report #5405001-2
Physician from UNITED STATES reported PREZISTA problem on July 24, 2007. Male patient, 48 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, cerebral atrophy. PREZISTA dosage: unknown. During the same period patient was treated with PROTONIX, ZYVOX, TRUVADA, NAPROXEN, IMODIUM, ACIPHEX, HYZAAR. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5405002-4
PREZISTA problem was reported by a Physician from FRANCE on July 24, 2007. Male patient, 42 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: rhabdomyolysis. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5410828-7
Health Professional from UNITED STATES reported PREZISTA problem on July 30, 2007. Female patient, weighting 121.0 lb, was diagnosed with acquired immunodeficiency syndrome and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: pyrexia, rash erythematous. PREZISTA dosage: unknown. During the same period patient was treated with NORVIR, VIREAD, VIDEX EC. Patient recovered.
Prezista Side Effects Report #5410829-9
PREZISTA problem was reported by a Physician from UNITED STATES on July 31, 2007. Male patient, 49 years of age, was diagnosed with hiv infection, rhinitis allergic and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: hepatitis. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, TRUVADA, LEVITRA, NASAREL. Patient recovered.
Prezista Side Effects Report #5413875-4
Physician from UNITED STATES reported PREZISTA problem on Aug 03, 2007. Male patient, 51 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: herpes zoster, immune reconstitution syndrome, pyrexia. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, ENFUVIRTIDE, GABAPENTIN. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5417849-9
PREZISTA problem was reported by a Physician from UNITED STATES on Aug 08, 2007. Female patient, weighting 120.0 lb, was diagnosed with hiv infection, antifungal prophylaxis, depression, anorexia, rash and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: meningitis aseptic, rash. PREZISTA dosage: unknown. During the same period patient was treated with NORVIR, TRUVADA, SULFAMETHOXAZOLE TM, SERTRALINE HYDROCHLORIDE, MARINOL, LOTRIMIN, HYDROCORTISONE. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5418339-X
Physician from UNITED STATES reported PREZISTA problem on Aug 08, 2007. Female patient, weighting 179.0 lb, was diagnosed with hiv infection, hypertension, headache, depression, asthma and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: depression, dyskinesia. PREZISTA dosage: unknown. During the same period patient was treated with NORVIR, ETRAVIRINE, CARDURA, PRINZIDE, IBUPROFEN, ZOLOFT, ADVAIR DISKUS. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5419302-5
PREZISTA problem was reported by a Physician from UNITED STATES on Aug 08, 2007. Male patient, 46 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: diffuse large b-cell lymphoma, immune reconstitution syndrome. PREZISTA dosage: unknown. During the same period patient was treated with NORVIR, FUZEON, REYATAZ, TRUVADA, BACTRIM, DIFLUCAN, PROCRIT. Patient was hospitalized and became disabled. Patient recovered.
Prezista Side Effects Report #5419304-9
Physician from UNITED STATES reported PREZISTA problem on Aug 09, 2007. Female patient, weighting 175.0 lb, was diagnosed with hiv infection, diabetes mellitus, hypertension and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: clostridium difficile colitis, hypersensitivity. PREZISTA dosage: unknown. During the same period patient was treated with ETRAVIRINE, EPZICOM, RITONAVIR, VALTREX, GLUCOPHAGE, METOPROLOL TARTRATE, CLARINEX. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5425058-2
PREZISTA problem was reported by a Physician from UNITED STATES on Aug 15, 2007. Female patient, weighting 179.0 lb, was diagnosed with hiv infection, hypertension, headache, depression, asthma and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: depression, dyskinesia. PREZISTA dosage: unknown. During the same period patient was treated with NORVIR, ETRAVIRINE, CARDURA, PRINZIDE, IBUPROFEN, ZOLOFT, ADVAIR DISKUS. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5430373-2
Physician from UNITED STATES reported PREZISTA problem on Aug 24, 2007. Female patient, 31 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: anaemia, coagulopathy, hepatitis, renal failure acute. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, TRUVADA, AMITRIPTYLINE, AZITHROMYCIN, CYCLOBENZAPRINE, DAPSONE, PROCRIT. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5436706-5
PREZISTA problem was reported by a Health Professional from UNITED STATES on Aug 22, 2007. Male patient, 43 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: adrenal insufficiency, dehydration, diarrhoea, headache, hypotension, liver function test abnormal, nausea, pyrexia, renal failure acute. PREZISTA dosage: unknown. During the same period patient was treated with KALETRA, RITONAVIR, TRUVADA, ENFUVIRTIDE, COMBIVIR, TENOFOVIR DISOPROXIL FUMARATE, AZITHROMYCIN. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5436707-7
Physician from BRAZIL reported PREZISTA problem on Aug 23, 2007. Male patient, 43 years of age, was diagnosed with acquired immunodeficiency syndrome, mental disorder and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: bundle branch block. PREZISTA dosage: unknown. During the same period patient was treated with FUZEO. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5438673-7
PREZISTA problem was reported by a Physician from UNITED STATES on Aug 28, 2007. Female patient, weighting 213.8 lb, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: transaminases increased. PREZISTA dosage: unknown. During the same period patient was treated with ETRAVIRINE, NORVIR, FAMVIR, OXYCODONE AND ACETAMINOPHEN, LIDOCAINE HYDROCHLORIDE, FLUCONAZOLE, ATENOLOL. Patient recovered.
Prezista Side Effects Report #5441426-7
Physician from FRANCE reported PREZISTA problem on Aug 24, 2007. Male patient, 42 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: rhabdomyolysis. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5441428-0
PREZISTA problem was reported by a Health Professional from UNITED STATES on Aug 24, 2007. Male patient, weighting 187.4 lb, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: chest pain, dyspnoea, haemoptysis, respiratory arrest. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, RALTEGRAVIR POTASSIUM, LAMIVUDINE. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5444207-3
Health Professional from UNITED STATES reported PREZISTA problem on Aug 28, 2007. Male patient, 40 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: anaemia, blood culture positive, chest pain, urinary tract infection. PREZISTA dosage: unknown. During the same period patient was treated with EPZICOM, RITONAVIR, AZITHROMYCIN, NEURONTIN, LOPRESSOR, BACTRIM, TRAZODONE HYDROCHLORIDE. Patient was hospitalized and became disabled. Patient recovered.
Prezista Side Effects Report #5444472-2
PREZISTA problem was reported by a Health Professional from UNITED STATES on Aug 28, 2007. Female patient, 44 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: anaemia, dehydration, hypercalcaemia, pancreatitis acute, pneumonia. PREZISTA dosage: unknown. During the same period patient was treated with NORVIR, EPIVIR, TYLENOL. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5444473-4
Physician from UNITED KINGDOM reported PREZISTA problem on Aug 30, 2007. Male patient, weighting 149.9 lb, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, blood pressure decreased, pneumothorax, renal failure acute. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, LAMIVUDINE, DIDANOSINE, TRUVADA. Patient was hospitalized. Patient died on 04/30/2007.
Prezista Side Effects Report #5444581-8
PREZISTA problem was reported by a Physician from UNITED KINGDOM on Aug 28, 2007. Male patient, weighting 143.3 lb, was diagnosed with hiv infection, lipids increased and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: blood creatine increased, haematuria, myalgia. PREZISTA dosage: unknown. During the same period patient was treated with ETRAVIRINE, TRUVADA, FENOFIBRATE. Patient recovered.
Prezista Side Effects Report #5453595-3
Physician from UNITED STATES reported PREZISTA problem on Sept 10, 2007. Female patient, weighting 179.0 lb, was diagnosed with hiv infection, hypertension, headache, depression, asthma and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: condition aggravated, conversion disorder, depression, essential hypertension, treatment noncompliance. PREZISTA dosage: unknown. During the same period patient was treated with ETRAVIRINE, NORVIR, CARDURA, PRINZIDE, IBUPROFEN, ZOLOFT, ADVAIR DISKUS. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5453596-5
PREZISTA problem was reported by a Physician from UNITED STATES on Sept 06, 2007. Female patient, weighting 175.0 lb, was diagnosed with hiv infection, diabetes mellitus, hypertension and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: clostridium difficile colitis, hypersensitivity. PREZISTA dosage: unknown. During the same period patient was treated with ETRAVIRINE, EPZICOM, RITONAVIR, VALTREX, GLUCOPHAGE, METOPROLOL TARTRATE, CLARINEX. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5456131-0
Physician from UNITED STATES reported PREZISTA problem on Sept 12, 2007. Female patient, 46 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: ischaemic cerebral infarction. PREZISTA dosage: unknown. During the same period patient was treated with VIDEX, ZIAGEN, LAMIVUDINE, EMTRICITABINE, FUZEON. Patient recovered.
Prezista Side Effects Report #5465183-3
PREZISTA problem was reported by a Physician from UNITED STATES on Sept 19, 2007. Male patient, 48 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness. PREZISTA dosage: unknown. During the same period patient was treated with PROTONIX, ZYVOX, TRUVADA, NAPROXEN, IMODIUM, ACIPHEX, HYZAAR. Patient was hospitalized. Patient recovered.
Prezista Side Effects Report #5465910-5
Physician from UNITED STATES reported PREZISTA problem on Sept 13, 2007. Female patient, 31 years of age, was diagnosed with hiv infection and was treated with PREZISTA. After drug was administered, patient experienced the following problems/side effects: anaemia, coagulopathy, hepatitis, renal failure acute. PREZISTA dosage: unknown. During the same period patient was treated with RITONAVIR, TRUVADA, AMITRIPTYLINE, AZITHROMYCIN, CYCLOBENZAPRINE, DAPSONE, PROCRIT. Patient was hospitalized. Patient recovered.
Showing 1-50 of 95 Next >
Drug Information: Darunavir
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a607042.html
(da roon' a veer)IMPORTANT WARNING:
| [Posted 03/12/2008] FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for darunavir (Prezista) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with darunavir/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of darunavir/ritonavir treatment. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista, http://www.fda.gov/medwatch/safety/2008/prezista_DHCP.pdf and http://www.fda.gov/cder/foi/label/2008/021976s003s004lbl.pdf. |
Why is this medication prescribed?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Darunavir is used with ritonavir (Norvir) and other medications to treat human immunodeficiency virus (HIV) in people who have already been treated for HIV. Darunavir is in a class of medications called protease inhibitors. It works by slowing the spread of HIV in the body. Darunavir does not cure HIV infection and may not prevent you from developing HIV-related illnesses. Darunavir does not prevent you from spreading HIV to other people.
How should this medicine be used?
Darunavir comes as a tablet to take by mouth. It is usually taken with food and with ritonavir twice a day. Take darunavir at around the same times 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 darunavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Do not take darunavir without ritonavir.
Swallow the tablets whole with a drink such as water or milk. Do not chew the tablets.
Darunavir controls HIV but does not cure it. Continue to take darunavir even if you feel well. Do not stop taking darunavir without talking to your doctor. If you stop taking darunavir or skip doses, your condition may become more difficult to treat. When your supply of darunavir starts to run low, get more from your doctor or pharmacist.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
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?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Before taking darunavir,
- tell your doctor and pharmacist if you are allergic to darunavir, ritonavir, sulfa medications, or any other medications. Ask your pharmacist if you are unsure if a medication you are allergic to is a sulfa medication.
- tell your doctor if you are taking any of the following medications: astemizole (Hismanal) (not available in the U.S.); cisapride (Propulsid); ergot-type medications such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Bellergal-S, Cafergot, Ergomar, Wigraine), and methylergonovine (Methergine); midazolam (Versed); pimozide (Orap); terfenadine (Seldane) (not available in the U.S.); or triazolam (Halcion). Your doctor will probably tell you not to take darunavir
- 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: anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); calcium-channel blockers such as felodipine (in Lexxel, Plendil), nicardipine (Cardene), and nifedipine (Adalat, Procardia); cholesterol-lowering medications (statins) such as atorvastatin (in Caduet, Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor); dexamethasone (Decadron, Dexone); fluticasone (in Advair, Flonase, Flovent); certain phosphodiesterase inhibitors (PDE-5 inhibitors)such as sildenafil (Revatio, Viagra), tadalafil (Cialis), and vardenafil (Levitra); other medications for HIV including efavirenz (Sustiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), and saquinavir (Invirase); medications for irregular heartbeat including amiodarone (Cordarone, Pacerone), bepridil (Vascor) (no longer available in the U.S.), and quinidine; certain medications for seizures such as carbamazepine (Equetro, Carbatrol, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek); certain medications that suppress the immune system such as cyclosporine (Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); methadone (Dolophine, Methadose); rifabutin (Mycobutin); rifampin (Rimactane, Rifadin);certain selective serotonin reuptake inhibitors (SSRIs) such as paroxetine (Paxil) and sertraline (Zoloft); and trazodone. Many other medications may also interact with darunavir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking didanosine (Videx), take it 1 hour before or 2 hours after you take darunavir.
- tell your doctor what herbal products you are taking, especially St. John's wort.
- tell your doctor if you have or have ever had diabetes or high blood sugar; hemophilia (bleeding disorder in which the blood does not clot properly); hepatitis (swelling of the liver caused by a virus) or any other liver disease; or an infection that does not go away or that comes and goes such as cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems), mycobacterium avium complex disease (MAC; a bacterial infection that may cause serious symptoms in people with AIDS), pneumonia, or tuberculosis (TB; a type of lung infection).
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking darunavir, call your doctor. Do not breastfeed if you are infected with HIV or are taking darunavir.
- you should know that darunavir may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, injections, or implants). Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.
- you should know that your body fat may increase or move to different areas of your body such as your breasts, upper back, neck, chest, and stomach area. Loss of fat from the legs, arms, and face can also happen.
What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.
What should I do if I forget a dose?
If you miss a dose by less than 6 hours, take the missed dose as soon as you remember it and then take the next dose at the scheduled time. However, if you miss a dose by more than 6 hours, 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?
Darunavir may cause hyperglycemia (high blood sugar). Call your doctor if you have any of the following symptoms of hyperglycemia:
- extreme thirst
- frequent urination
- extreme hunger
- weakness
- blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of these symptoms:
- dry mouth
- nausea and vomiting
- shortness of breath
- breath that smells fruity
- decreased consciousness
Darunavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- diarrhea
- nausea
- stomach pain
- constipation
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- rash
- blisters
- fever
- swelling, tenderness, redness, or other signs of infection
Darunavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
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?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
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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