Baraclude 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 Baraclude reports: 169.
Baraclude FDA safety alerts: 2007 .
Reported deaths: 36 Reported hospitalizations: 70.
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FDA Reported Baraclude Side Effects: death, abdominal pain upper, renal failure acute, hepatic neoplasm malignant, blood hiv rna decreased, white blood cell count decreased, pain in extremity, myalgia, chest discomfort, hepatitis fulminant, nausea.
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Showing 1-100 of 169 Next >
Baraclude Side Effects Report #5373343-5Physician from GERMANY reported BARACLUDE problem on June 25, 2007. Male patient, 67 years of age, weighting 178.6 lb, was diagnosed with hepatitis b, coronary artery bypass, coronary artery disease, hypertension and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hypertension. BARACLUDE dosage: unknown. During the same period patient was treated with PLAVIX, ACERCOMP, CARVEDILOL. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5374744-1
BARACLUDE problem was reported by a Consumer or non-health professional from SINGAPORE on June 25, 2007. Male patient, 52 years of age, was treated with BARACLUDE. BARACLUDE dosage: unknown. Patient died on 06/04/2007.
Baraclude Side Effects Report #5054744-1
Consumer or non-health professional from UNITED STATES reported BARACLUDE problem on July 07, 2006. Male patient, 50 years of age, was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: renal failure. BARACLUDE dosage: unknown. During the same period patient was treated with RAPAMUNE. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5063399-1
BARACLUDE problem was reported by a Physician from CHINA on July 17, 2006. Male patient, 41 years of age, weighting 132.3 lb, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, retinal haemorrhage. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5095477-5
Health Professional from UNITED STATES reported BARACLUDE problem on Sept 01, 2006. Male patient, weighting 266.0 lb, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: chromaturia, rhabdomyolysis. BARACLUDE dosage: 0.5 MG QD PO. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5115090-0
BARACLUDE problem was reported by a Consumer or non-health professional from UNITED STATES on June 13, 2006. Female patient, weighting 143.3 lb, was diagnosed with hepatitis b, seasonal allergy and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: pregnancy. BARACLUDE dosage: unknown. During the same period patient was treated with ZYRTEC. Patient recovered.
Baraclude Side Effects Report #5115092-4
Pharmacist from UNITED STATES reported BARACLUDE problem on July 18, 2006. Male patient, 52 years of age, was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: fatigue, weight decreased. BARACLUDE dosage: unknown. During the same period patient was treated with ALPRAZOLAM, NORCO, AMBIEN. Patient recovered.
Baraclude Side Effects Report #5126106-X
BARACLUDE problem was reported by a Consumer or non-health professional from CHINA on Mar 22, 2006. Male patient, 44 years of age, was diagnosed with chronic hepatitis and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, anorexia, blood bilirubin increased, insomnia, ocular icterus. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5132777-4
Consumer or non-health professional from UNITED STATES reported BARACLUDE problem on Oct 18, 2006. Female patient, 60 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5140184-3
BARACLUDE problem was reported by a Consumer or non-health professional from CHINA on Oct 23, 2006. Male patient, 63 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatic neoplasm malignant, metastases to lymph nodes. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5146560-7
Consumer or non-health professional from CHINA reported BARACLUDE problem on Oct 23, 2006. Male patient, 63 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatic neoplasm malignant, metastases to lymph nodes. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5151435-3
BARACLUDE problem was reported by a Consumer or non-health professional from CHINA on Oct 23, 2006. Male patient, 63 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatic cirrhosis, hepatic neoplasm malignant, metastases to lymph nodes, splenomegaly. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5154187-6
Consumer or non-health professional from SINGAPORE reported BARACLUDE problem on Nov 09, 2006. Male patient, 44 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: peritonitis bacterial, septic shock. BARACLUDE dosage: unknown. During the same period patient was treated with LAMIVUDINE, ANTIBIOTICS. Patient died on 08/30/2006.
Baraclude Side Effects Report #5154194-3
BARACLUDE problem was reported by a Consumer or non-health professional from INDIA on Oct 27, 2006. Male patient, 55 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. BARACLUDE dosage: unknown. Patient died.
Baraclude Side Effects Report #5156383-0
Physician from UNITED STATES reported BARACLUDE problem on Oct 18, 2006. Female patient, 60 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: diabetic ketoacidosis. BARACLUDE dosage: unknown. During the same period patient was treated with PROCARDIA, DYAZIDE, ESTAZOLAM, PROZAC, VITAMIN E. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5157630-1
BARACLUDE problem was reported by a Consumer or non-health professional from SINGAPORE on Oct 27, 2006. Female patient, 45 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatic failure, hepatitis b virus. BARACLUDE dosage: unknown. Patient died.
Baraclude Side Effects Report #5157633-7
Health Professional from INDIA reported BARACLUDE problem on Oct 26, 2006. Male patient, 59 years of age, was diagnosed with hepatitis b, candidiasis and was treated with BARACLUDE. BARACLUDE dosage: unknown. During the same period patient was treated with BACLOFEN, FORCAN. Patient died.
Baraclude Side Effects Report #5161623-8
BARACLUDE problem was reported by a Physician from CHINA on Nov 20, 2006. Male patient, 42 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatic neoplasm malignant, portal vein thrombosis, splenomegaly. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5161624-X
Physician from SINGAPORE reported BARACLUDE problem on Nov 23, 2006. Male patient, 21 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatic encephalopathy. BARACLUDE dosage: unknown. Patient died on 11/21/2006.
Baraclude Side Effects Report #5163241-4
BARACLUDE problem was reported by a Consumer or non-health professional from SINGAPORE on Nov 23, 2006. Female patient, 66 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. BARACLUDE dosage: unknown. Patient died.
Baraclude Side Effects Report #5164944-8
Consumer or non-health professional from SINGAPORE reported BARACLUDE problem on Nov 28, 2006. Male patient, 44 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. BARACLUDE dosage: unknown. Patient died on 11/14/2006.
Baraclude Side Effects Report #5171149-3
BARACLUDE problem was reported by a Consumer or non-health professional from SINGAPORE on Dec 06, 2006. Male patient, 61 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hypotension. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5173323-9
Consumer or non-health professional from CHINA reported BARACLUDE problem on Oct 23, 2006. Male patient, 63 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatic cirrhosis, hepatic neoplasm malignant, metastases to lymph nodes, splenomegaly. BARACLUDE dosage: unknown. Patient was hospitalized. Patient died on 12/07/2006.
Baraclude Side Effects Report #5179160-3
BARACLUDE problem was reported by a Consumer or non-health professional from SINGAPORE on Dec 12, 2006. Male patient, 61 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatorenal syndrome. BARACLUDE dosage: unknown. Patient died on 12/12/2006.
Baraclude Side Effects Report #5188012-4
Consumer or non-health professional from INDIA reported BARACLUDE problem on Nov 28, 2006. Male patient, 44 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatic cirrhosis. BARACLUDE dosage: unknown. Patient died on 11/14/2006.
Baraclude Side Effects Report #5188811-9
BARACLUDE problem was reported by a Health Professional from UNITED STATES on Oct 06, 2006. Male patient, 36 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: viral load increased. BARACLUDE dosage: unknown. During the same period patient was treated with PAXIL. Patient recovered.
Baraclude Side Effects Report #5188813-2
Physician from UNITED STATES reported BARACLUDE problem on Oct 26, 2006. Male patient, 57 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased. BARACLUDE dosage: unknown. During the same period patient was treated with CLARITIN, IBUPROFEN, ALCOHOL. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5195011-5
BARACLUDE problem was reported by a Consumer or non-health professional from CHINA on Dec 18, 2006. Male patient, 47 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatitis fulminant. BARACLUDE dosage: unknown. Patient recovered.
Baraclude Side Effects Report #5195016-4
Physician from CHINA reported BARACLUDE problem on Dec 18, 2006. Male patient, 52 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatitis fulminant. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5378982-3
BARACLUDE problem was reported by a Health Professional from SWEDEN on June 26, 2007. Male patient, 75 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, sepsis. BARACLUDE dosage: unknown. During the same period patient was treated with SIMVASTATIN, MINIDIAB, TENORMIN, ZOLPIDEM TARTRATE, ATACAND HCT. Patient was hospitalized. Patient died.
Baraclude Side Effects Report #5378990-2
Health Professional from JAPAN reported BARACLUDE problem on July 02, 2007. Male patient, 50 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: erectile dysfunction. BARACLUDE dosage: unknown. Patient recovered.
Baraclude Side Effects Report #5379020-9
BARACLUDE problem was reported by a Physician from AUSTRALIA on June 26, 2007. Male patient, 67 years of age, weighting 202.8 lb, was diagnosed with hepatitis b virus and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: renal failure. BARACLUDE dosage: unknown. During the same period patient was treated with HUMALOG, ATENOLOL, LERCANIDIPINE, CANDESARTAN CILEXETIL, PERINDOPRIL, FRUSEMIDE, ADEFOVIR DIPIVOXIL, LAMIVUDINE. Patient was hospitalized and became disabled. Patient recovered.
Baraclude Side Effects Report #5379142-2
Physician from JAPAN reported BARACLUDE problem on June 27, 2007. Male patient, 60 years of age, was diagnosed with hepatitis b, gastric ulcer, ascites and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: renal failure acute. BARACLUDE dosage: unknown. During the same period patient was treated with PARIET, LASIX, SPIRONOLACTONE, SELBEX. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5379165-3
BARACLUDE problem was reported by a Consumer or non-health professional from PHILIPPINES on June 27, 2007. Male patient, 49 years of age, was diagnosed with alanine aminotransferase increased, hepatitis b dna assay, lymphoma and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: neutropenia. BARACLUDE dosage: unknown. During the same period patient was treated with DOXORUBICIN, VINCRISTINE, PREDNISONE. Patient recovered.
Baraclude Side Effects Report #5379872-2
Physician from JAPAN reported BARACLUDE problem on June 26, 2007. Male patient, 49 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, hepatic function abnormal, white blood cell count decreased. BARACLUDE dosage: unknown. During the same period patient was treated with LASIX, ALDACTONE, LIVACT, NEO MINOPHAGEN C, FESIN, CISPLATIN. Patient recovered.
Baraclude Side Effects Report #5382637-9
BARACLUDE problem was reported by a Physician from JAPAN on July 02, 2007. Male patient, 49 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, white blood cell count decreased. BARACLUDE dosage: unknown. During the same period patient was treated with LASIX, ALDACTONE, LIVACT, NEO MINOPHAGEN C, FESIN, CISPLATIN. Patient recovered.
Baraclude Side Effects Report #5382813-5
Consumer or non-health professional from SINGAPORE reported BARACLUDE problem on July 09, 2007. Male patient, 52 years of age, was treated with BARACLUDE. BARACLUDE dosage: unknown. Patient died on 06/04/2007.
Baraclude Side Effects Report #5382814-7
BARACLUDE problem was reported by a Physician from JAPAN on July 06, 2007. Male patient, 69 years of age, was diagnosed with hepatic cirrhosis and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: gastroenteritis, peritonitis bacterial. BARACLUDE dosage: unknown. During the same period patient was treated with URIEF. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5388445-7
Pharmacist from JAPAN reported BARACLUDE problem on July 12, 2007. Male patient, 66 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: urinary retention. BARACLUDE dosage: unknown. During the same period patient was treated with FLOMOX, EMPYNASE, LOXONIN. Patient recovered.
Baraclude Side Effects Report #5394360-5
BARACLUDE problem was reported by a Pharmacist from JAPAN on July 17, 2007. Male patient, 65 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: dysuria, herpes zoster, urinary retention. BARACLUDE dosage: unknown. During the same period patient was treated with FLOMOX, EMPYNASE, LOXONIN. Patient was hospitalized and became disabled. Patient recovered.
Baraclude Side Effects Report #5394362-9
Physician from GERMANY reported BARACLUDE problem on July 16, 2007. Female patient, 63 years of age, weighting 132.3 lb, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: lymphoma. BARACLUDE dosage: unknown. Patient recovered.
Baraclude Side Effects Report #5395204-8
BARACLUDE problem was reported by a Physician from SWITZERLAND on July 16, 2007. Female patient, 49 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: viral mutation identified. BARACLUDE dosage: unknown. Patient recovered.
Baraclude Side Effects Report #5400290-2
Consumer or non-health professional from CHINA reported BARACLUDE problem on July 23, 2007. Male patient, 32 years of age, weighting 138.9 lb, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: nephrotic syndrome. BARACLUDE dosage: unknown. During the same period patient was treated with ESSENTIALE, TIOPRONIN. Patient recovered.
Baraclude Side Effects Report #5401686-5
BARACLUDE problem was reported by a Consumer or non-health professional from SINGAPORE on July 26, 2007. Male patient, 68 years of age, was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. BARACLUDE dosage: unknown. Patient died on 04/17/2007.
Baraclude Side Effects Report #5404166-6
Consumer or non-health professional from SINGAPORE reported BARACLUDE problem on July 27, 2007. Female patient, 70 years of age, was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatitis b. BARACLUDE dosage: unknown. Patient died.
Baraclude Side Effects Report #5406305-X
BARACLUDE problem was reported by a Physician from GERMANY on Aug 01, 2007. Male patient, 52 years of age, was diagnosed with hepatitis b, polyarthritis, reflux oesophagitis and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: gastrointestinal hypomotility, pneumonia, sepsis, subileus, tracheobronchitis. BARACLUDE dosage: unknown. During the same period patient was treated with PREDNISONE, AZULFIDINE, PANTOPRAZOLE. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5409414-4
Pharmacist from GERMANY reported BARACLUDE problem on Aug 06, 2007. Male patient, 35 years of age, was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: epilepsy. BARACLUDE dosage: unknown. During the same period patient was treated with DOCITON, PHYTOMENADIONE. Patient recovered.
Baraclude Side Effects Report #5412579-1
BARACLUDE problem was reported by a Health Professional from JAPAN on Aug 10, 2007. Male patient, 58 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: erectile dysfunction. BARACLUDE dosage: unknown. Patient recovered.
Baraclude Side Effects Report #5422178-3
Consumer or non-health professional from UNITED KINGDOM reported BARACLUDE problem on Aug 20, 2007. Male patient, 60 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatic failure. BARACLUDE dosage: unknown. During the same period patient was treated with LANSOPRAZOLE. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5426346-6
BARACLUDE problem was reported by a Physician from JAPAN on Aug 22, 2007. Male patient, 90 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatic neoplasm malignant. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5426366-1
Pharmacist from JAPAN reported BARACLUDE problem on Aug 22, 2007. Male patient, 65 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: herpes zoster, urinary retention. BARACLUDE dosage: unknown. During the same period patient was treated with FLOMOX, LOXONIN, EMPYNASE. Patient was hospitalized and became disabled. Patient recovered.
Baraclude Side Effects Report #5427630-2
BARACLUDE problem was reported by a Physician from GERMANY on Aug 23, 2007. Male patient, 33 years of age, weighting 143.3 lb, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: blood hiv rna decreased. BARACLUDE dosage: unknown. Patient recovered.
Baraclude Side Effects Report #5431516-7
Physician from SWITZERLAND reported BARACLUDE problem on Aug 27, 2007. Female patient, 42 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: blood hiv rna decreased. BARACLUDE dosage: unknown. Patient recovered.
Baraclude Side Effects Report #5440443-0
BARACLUDE problem was reported by a Physician from CHINA on Aug 29, 2007. Male patient, 20 years of age, was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: muscular weakness. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5442962-X
Consumer or non-health professional from CHINA reported BARACLUDE problem on Aug 31, 2007. Female patient, 31 years of age, weighting 132.3 lb, was diagnosed with hepatitis b virus and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: muscular weakness. BARACLUDE dosage: unknown. During the same period patient was treated with PHOSPHATIDYLCHOLINE, BICYCLOL. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5445022-7
BARACLUDE problem was reported by a Health Professional from JAPAN on Sept 05, 2007. Male patient, 49 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: cardiac hypertrophy, chest discomfort. BARACLUDE dosage: unknown. Patient recovered.
Baraclude Side Effects Report #5446507-X
Consumer or non-health professional from CHINA reported BARACLUDE problem on Sept 05, 2007. Female patient, 31 years of age, weighting 132.3 lb, was diagnosed with hepatitis b virus and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: muscular weakness. BARACLUDE dosage: unknown. During the same period patient was treated with PHOSPHATIDYLCHOLINE, BICYCLOL. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5447338-7
BARACLUDE problem was reported by a Consumer or non-health professional from CHINA on Sept 05, 2007. Female patient, 31 years of age, weighting 132.3 lb, was diagnosed with hepatitis b virus and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: muscular weakness. BARACLUDE dosage: unknown. During the same period patient was treated with BICYCLOL. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5447342-9
Pharmacist from GERMANY reported BARACLUDE problem on Sept 06, 2007. Male patient, 34 years of age, weighting 185.2 lb, was diagnosed with hepatic cirrhosis and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: epilepsy, grand mal convulsion, loss of consciousness, protein total increased. BARACLUDE dosage: unknown. During the same period patient was treated with DOCITON, PHYTOMENADIONE. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5447597-0
BARACLUDE problem was reported by a Pharmacist from UNITED STATES on Sept 05, 2007. Male patient, weighting 114.0 lb, was diagnosed with hepatitis b virus, viral hepatitis carrier and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: asthenia, muscle atrophy, temperature intolerance, weight decreased. BARACLUDE dosage: 0.5MG DAILY PO. Patient recovered.
Baraclude Side Effects Report #5449041-6
Physician from JAPAN reported BARACLUDE problem on Sept 07, 2007. Male patient, 49 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, hepatic neoplasm malignant, white blood cell count decreased. BARACLUDE dosage: unknown. During the same period patient was treated with LASIX, ALDACTONE, LIVACT, NEO MINOPHAGEN C, FESIN, CISPLATIN. Patient died on 08/01/2007.
Baraclude Side Effects Report #5449121-5
BARACLUDE problem was reported by a Physician from JAPAN on Sept 11, 2007. Male patient, 90 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: hepatic neoplasm malignant. BARACLUDE dosage: unknown. Patient was hospitalized. Patient recovered.
Baraclude Side Effects Report #5452721-X
Physician from GERMANY reported BARACLUDE problem on Sept 11, 2007. Female patient, 30 years of age, weighting 121.3 lb, was diagnosed with hepatitis b, headache and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, fatigue. BARACLUDE dosage: unknown. During the same period patient was treated with IBUPROFEN. Patient recovered.
Baraclude Side Effects Report #5454532-8
BARACLUDE problem was reported by a Physician from GERMANY on Sept 14, 2007. Male patient, weighting 138.9 lb, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: blood hiv rna decreased. BARACLUDE dosage: unknown. Patient recovered.
Baraclude Side Effects Report #5464217-X
Consumer or non-health professional from UNITED STATES reported BARACLUDE problem on Sept 18, 2007. Male patient, 51 years of age, weighting 141.1 lb, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: blood hiv rna decreased. BARACLUDE dosage: unknown. During the same period patient was treated with LISINOPRIL, RANITIDINE, HYDROCHLOROTHIAZIDE. Patient recovered.
Baraclude Side Effects Report #5469706-X
BARACLUDE problem was reported by a Consumer or non-health professional from SINGAPORE on Sept 21, 2007. Male patient, 58 years of age, was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: neoplasm malignant. BARACLUDE dosage: unknown. Patient died on 09/08/2007.
Baraclude Side Effects Report #5469811-8
Consumer or non-health professional from UNITED STATES reported BARACLUDE problem on Aug 23, 2007. Male patient, 33 years of age, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: chest pain, dyspnoea. BARACLUDE dosage: unknown. Patient recovered.
Baraclude Side Effects Report #5469816-7
BARACLUDE problem was reported by a Consumer or non-health professional from UNITED STATES on July 25, 2007. Female patient, 38 years of age, weighting 121.3 lb, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: pregnancy. BARACLUDE dosage: unknown. Patient recovered.
Baraclude Side Effects Report #5470899-9
Health Professional from UNITED STATES reported BARACLUDE problem on Sept 26, 2007. Male patient, 51 years of age, weighting 141.1 lb, was diagnosed with hepatitis b and was treated with BARACLUDE. After drug was administered, patient experienced the following problems/side effects: blood hiv rna decreased. BARACLUDE dosage: unknown. During the same period patient was treated with LISINOPRIL, RANITIDINE, HYDROCHLOROTHIAZIDE. Patient recovered.
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Drug Information: Entecavir
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a605028.html
(en te' ka veer)IMPORTANT WARNING:
| [UPDATE 08/16/2007] FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the following sections of the entecavir (Baraclude) prescribing information: BOXED WARNINGS, MICROBIOLOGY/Antiviral Activity against HIV (human immunodeficiency virus), WARNINGS/Co-infection with HIV, PRECAUTIONS/Information for Patients, and Patient Package Insert. Baraclude therapy is not recommended for HIV/hepatitis B virus (HBV) co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) due to the potential for the development of HIV resistance. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Baraclude, http://www.fda.gov/medwatch/safety/2007/Baraclude%20DHCP_aug1607.pdf and http://www.fda.gov/medwatch/safety/2007/Baraclude_PI_jul2407.pdf. |
IMPORTANT WARNING:
| Entecavir can cause serious or life-threatening damage to the liver and a condition called lactic acidosis (a buildup of acid in the blood).Tell your doctor if you drink or have ever drunk large amounts of alcohol, if you use or have ever used injectable street drugs, and if you have or have ever had cirrhosis (scarring) of the liver or any liver disease other than hepatitis B. If you experience any of the following symptoms, call your doctor immediately: yellowing of the skin or eyes; dark-colored urine; light-colored bowel movements; difficulty breathing; stomach pain or swelling; nausea; vomiting; unusual muscle pain; loss of appetite for at least several days; lack of energy; extreme weakness or tiredness; feeling cold especially in the arms or legs; dizziness or lightheadedness; or fast or irregular heartbeat.Do not stop taking entecavir without talking to your doctor. When you stop taking entecavir your hepatitis may get worse. This is most likely to happen during the first several months after you stop taking entecavir. Take entecavir exactly as directed. Be careful not to miss doses or run out of entecavir. Refill your prescription at least 5 days before you expect that you will need the new supply of medication. If you experience any of the following symptoms after you stop taking entecavir, call your doctor immediately: extreme tiredness, weakness, nausea, vomiting, loss of appetite, yellowing of the skin or eyes, dark-colored urine, light-colored bowel movements, or muscle or joint pain.Keep all appointments with your doctor and the laboratory before, during, and for a few months after your treatment with entecavir. Your doctor will order certain tests to check your body's response to entecavir during this time. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.Talk to your doctor about the risks of taking entecavir. |
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.
Entecavir is used to treat chronic (long-term) hepatitis B infection (swelling of the liver caused by a virus) in people who have liver damage. Entecavir is in a class of medications called nucleoside analogs. It works by decreasing the amount of hepatitis B virus (HBV) in the body. Entecavir does not cure HBV and may not prevent complications of chronic hepatitis B such as cirrhosis of the liver or liver cancer. Entecavir does not prevent the spread of HBV to other people.
How should this medicine be used?
Entecavir comes as a tablet and solution (liquid) to take by mouth. It is usually taken once a day on an empty stomach, at least 2 hours after a meal and at least 2 hours before the next meal. Take entecavir at 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 entecavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
To use the entecavir solution, follow these steps:
- Hold the spoon that came with your medication upright and slowly fill it with entecavir solution up to the mark that matches your dose.
- Hold the spoon with the volume marks facing you and check to see that the top of the liquid is level with the mark that matches your dose.
- Swallow the medication right from the measuring spoon. Do not mix the medication with water or any other liquid
- Rinse the spoon with water after each use, and allow it to air dry.
- Put the spoon in a safe place where it will not get lost, because you will need to use it every time you take your medication. If you do lose the dosing spoon, call your doctor or pharmacist.
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 entecavir,
- tell your doctor and pharmacist if you are allergic to entecavir, or any other medications,or any of the ingredients in entecavir tablets or solution. Ask your pharmacist for a list of the ingredients..
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: aminoglycoside antibiotics such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Neo-Rx, NeoFradin), paromomycin (Humatin), streptomycin, and tobramycin (Tobi, Nebcin); amphotericin B (Fungizone); medications to prevent rejection of a transplanted organ such as cyclosporine (Neoral, Sandimmune) or tacrolimus (Prograf);probenecid; or vancomycin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have had a liver transplant (surgery to replace a diseased liver), HIV and/or AIDS, or if you have or have ever had kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking entecavir, call your doctor. Do not breastfeed while you are taking entecavir.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking entecavir.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
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?
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.
Entecavir may cause side effects. Tell your doctor if this symptom is severe or does not go away:
- headache
Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING section, call your doctor immediately.
Entecavir may cause other side effects. Call your doctor if you have any unusual problems while using 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 and pets. Store it at room temperature and away from excess heat, light, and moisture (not in the bathroom medicine cabinet or near the kitchen sink). 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.
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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