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Review Valacyclovir Safety Reports submitted to FDA

Total Valacyclovir reports: 42.
Valacyclovir FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 16.
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FDA Reported Valacyclovir Side Effects: foetal disorder, abortion induced, congenital anomaly, brain damage, viral load increased, amniocentesis abnormal, deafness unilateral, vascular calcification, premature baby, dysarthria, dizziness.
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Valacyclovir Side Effects Report #5647030-X
Consumer or non-health professional from DENMARK reported VALACYCLOVIR problem on Feb 28, 2008. Female patient, 64 years of age, weighting 123.5 lb, was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: dyskinesia, dysphemia, tremor. VALACYCLOVIR dosage: unknown. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5653409-2
VALACYCLOVIR problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 03, 2008. Female patient, 53 years of age, was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: ear infection, headache, hepatic lesion, lymphadenopathy, panic attack, pruritus, sarcoidosis. VALACYCLOVIR dosage: 500MG TWICE PER DAY. Patient recovered.

Valacyclovir Side Effects Report #5655254-0
Physician from FRANCE reported VALACYCLOVIR problem on Feb 28, 2008. Female patient, 59 years of age, weighting 160.9 lb, was diagnosed with genital herpes and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: haematoma, mean cell haemoglobin concentration decreased, mean cell volume increased. VALACYCLOVIR dosage: unknown. During the same period patient was treated with MILLEPERTUIS. Patient recovered.

Valacyclovir Side Effects Report #5669451-1
VALACYCLOVIR problem was reported by a Consumer or non-health professional from JAPAN on Mar 14, 2008. Male patient, 73 years of age, was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: anaemia, anuria, blood creatinine increased, oedema, renal failure acute, renal impairment. VALACYCLOVIR dosage: unknown. During the same period patient was treated with NSAID, ANGIOTENSIN II ANTAGONIST. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5672826-8
Consumer or non-health professional from JAPAN reported VALACYCLOVIR problem on Mar 04, 2008. Male patient, 73 years of age, was diagnosed with herpes zoster, cardiac disorder and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: anaemia, anuria, haemodialysis, oedema, renal failure acute. VALACYCLOVIR dosage: unknown. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5672962-6
VALACYCLOVIR problem was reported by a Consumer or non-health professional from SWEDEN on Mar 18, 2008. Male patient, 36 years of age, was diagnosed with herpes virus infection, encephalitis herpes and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: anxiety, confusional state, cotard's syndrome, dehydration, depression, diarrhoea, dysarthria, fatigue, fear. VALACYCLOVIR dosage: 500MG TWICE PER DAY. During the same period patient was treated with CYCLOSPORINE, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5673001-3
Pharmacist from FRANCE reported VALACYCLOVIR problem on Mar 12, 2008. Female patient, 47 years of age, was diagnosed with herpes virus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: conjunctival haemorrhage, epistaxis. VALACYCLOVIR dosage: unknown. Patient recovered.

Valacyclovir Side Effects Report #5684370-2
VALACYCLOVIR problem was reported by a Consumer or non-health professional from FRANCE on Mar 19, 2008. Male patient, 61 years of age, was diagnosed with cardiogenic shock and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, neutropenia. VALACYCLOVIR dosage: unknown. During the same period patient was treated with LANSOPRAZOLE, HEPARIN, ASPIRIN, BURINEX, DOBUTAMINE, PIPERACILLIN AND TAZOBACTAM. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5621953-X
Physician from UNITED STATES reported VALACYCLOVIR problem on Feb 06, 2008. Male patient, 71 years of age, weighting 207.2 lb, was diagnosed with glioblastoma multiforme and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: anaemia, haemoglobin decreased, haemoptysis, lymphopenia, platelet count decreased, pulmonary embolism, pulmonary haemorrhage, thrombocytopenia. VALACYCLOVIR dosage: unknown. During the same period patient was treated with BACTRIM, TEMOZOLOMIDE, RADIATION. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5629676-8
VALACYCLOVIR problem was reported by a Consumer or non-health professional from FRANCE on Feb 12, 2008. Female patient, 71 years of age, was diagnosed with herpes zoster and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, aphasia, confusional state, csf glucose decreased, csf protein increased, eye disorder, motor dysfunction, toxic encephalopathy, tremor. VALACYCLOVIR dosage: unknown. During the same period patient was treated with VELCADE, DIALYSIS. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5635646-6
Consumer or non-health professional from SWEDEN reported VALACYCLOVIR problem on Feb 05, 2008. Female patient, 35 years of age, was diagnosed with herpes zoster and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: anxiety, ataxia, cotard's syndrome, crying, dialysis, fatigue, gait disturbance, haemodialysis, hallucination, auditory. VALACYCLOVIR dosage: unknown. During the same period patient was treated with PREDNISOLONE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5635647-8
VALACYCLOVIR problem was reported by a Consumer or non-health professional from SWEDEN on Feb 05, 2008. Male patient, 36 years of age, was diagnosed with herpes virus infection, encephalitis herpes and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: cotard's syndrome, dehydration, diarrhoea, encephalitis herpes, fatigue, feeling abnormal, renal impairment. VALACYCLOVIR dosage: 500 MG / TWICE PER DAY / ORAL. During the same period patient was treated with CYCLOSPORINE, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5644445-0
Consumer or non-health professional from UNITED STATES reported VALACYCLOVIR problem on Jan 02, 2007. Female patient, 44 years of age, was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: abdominal pain, rash erythematous. VALACYCLOVIR dosage: 500MG PER DAY. Patient recovered.

Valacyclovir Side Effects Report #5644739-9
VALACYCLOVIR problem was reported by a Consumer or non-health professional from UNITED STATES on July 06, 2007. Male patient, 47 years of age, was diagnosed with prophylaxis and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: hepatic enzyme increased. VALACYCLOVIR dosage: unknown. During the same period patient was treated with PRAVACHOL, DIGOXIN, LORAZEPAM, IMODIUM. Patient recovered.

Valacyclovir Side Effects Report #5644829-0
Consumer or non-health professional from UNITED STATES reported VALACYCLOVIR problem on Aug 27, 2007. Male patient, 32 years of age, was diagnosed with genital herpes and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: herpes virus infection. VALACYCLOVIR dosage: 500MG PER DAY. During the same period patient was treated with LEXAPRO. Patient recovered.

Valacyclovir Side Effects Report #5585594-5
VALACYCLOVIR problem was reported by a Physician from SPAIN on Jan 04, 2008. Female patient, 89 years of age, was diagnosed with herpes zoster and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: anuria, confusional state, dehydration, fatigue, malaise, renal failure acute. VALACYCLOVIR dosage: unknown. During the same period patient was treated with ENALAPRIL, ZOVIRAX, TOBRAMYCIN. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5592355-X
Pharmacist from SWEDEN reported VALACYCLOVIR problem on Jan 07, 2008. Male patient, 36 years of age, was diagnosed with herpes virus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: anxiety, blood creatinine increased, confusional state, cotard's syndrome, dehydration, delusion, depression, diarrhoea, dysarthria. VALACYCLOVIR dosage: 500 MG;TWICE A DAY. During the same period patient was treated with CYCLOSPORINE, PREDNISONE. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5593326-X
VALACYCLOVIR problem was reported by a Consumer or non-health professional from FRANCE on Jan 10, 2008. Female patient, 87 years of age, was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: acidosis, acute respiratory distress syndrome, alanine aminotransferase increased, altered state of consciousness, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood creatinine increased, coma, dehydration. VALACYCLOVIR dosage: unknown. During the same period patient was treated with TAREG, NEURONTIN, TOPALGIC, PARACETAMOL, LEVOTHYROX, ARICEPT, MEMANTINE, NEULEPTIL. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5598321-2
Pharmacist from FRANCE reported VALACYCLOVIR problem on Jan 17, 2008. Female patient, 86 years of age, was diagnosed with herpes zoster and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: acute coronary syndrome, cardiac arrest, disorientation, hallucination, auditory, hallucination, visual, lymphocyte count increased, meningitis. VALACYCLOVIR dosage: 1000MG THREE TIMES PER DAY. During the same period patient was treated with CRESTOR, ALPRESS, MONICOR LP, APROVEL, FLODIL LP, EUPRESSYL, KARDEGIC. Patient was hospitalized. Patient died on 11/12/2007.

Valacyclovir Side Effects Report #5600125-9
VALACYCLOVIR problem was reported by a Consumer or non-health professional from FRANCE on Jan 14, 2008. Male patient, 44 years of age, was diagnosed with herpes zoster, toxoplasmosis, hiv infection, convulsion and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: pain, pyrexia, rash, renal colic. VALACYCLOVIR dosage: unknown. During the same period patient was treated with ADIAZINE, LEDERFOLINE, TRIFLUCAN, NEURONTIN, COMBIVIR, KALETRA, KEPPRA, MALOCIDE. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5621537-3
Physician from CZECH REPUBLIC reported VALACYCLOVIR problem on Jan 15, 2008. Female patient was diagnosed with renal transplant and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus infection, nephritis. VALACYCLOVIR dosage: unknown. During the same period patient was treated with AMPHOTERICIN B. Patient recovered.

Valacyclovir Side Effects Report #5556220-6
VALACYCLOVIR problem was reported by a Consumer or non-health professional from JAPAN on Nov 26, 2007. Female patient, 74 years of age, was diagnosed with herpes zoster and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: dialysis, dysarthria, encephalopathy, hallucination. VALACYCLOVIR dosage: 1000 MG, PER DAY; ORAL. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5557623-6
Physician from PHILIPPINES reported VALACYCLOVIR problem on Dec 13, 2007. Male patient, 42 years of age, was diagnosed with herpes zoster and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: azotaemia. VALACYCLOVIR dosage: unknown. Patient was hospitalized. Patient recovered.

Valacyclovir Side Effects Report #5572133-8
VALACYCLOVIR problem was reported by a Consumer or non-health professional from FRANCE on Dec 11, 2007. Female patient, child 9 years of age, was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: stevens-johnson syndrome. VALACYCLOVIR dosage: unknown. Patient recovered.

Valacyclovir Side Effects Report #5468153-4
Consumer or non-health professional from FRANCE reported VALACYCLOVIR problem on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: amniocentesis abnormal, congenital anomaly, deafness neurosensory, deafness unilateral, foetal disorder, hepatitis, laboratory test abnormal, viral load increased. VALACYCLOVIR dosage: unknown. Patient recovered.

Valacyclovir Side Effects Report #5468163-7
VALACYCLOVIR problem was reported by a Consumer or non-health professional from FRANCE on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: abortion induced. VALACYCLOVIR dosage: unknown. During the same period patient was treated with LIGNOCAINE HYDROCHLORIDE, MIFEPRISTONE, MISOPROSTOL. Patient recovered.

Valacyclovir Side Effects Report #5468181-9
Consumer or non-health professional from FRANCE reported VALACYCLOVIR problem on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: foetal disorder, gastrointestinal disorder, hepatomegaly, meconium ileus, ultrasound antenatal screen abnormal, viral load increased. VALACYCLOVIR dosage: unknown. Patient recovered.

Valacyclovir Side Effects Report #5468184-4
VALACYCLOVIR problem was reported by a Consumer or non-health professional from FRANCE on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: congenital anomaly, foetal disorder, nervous system disorder, premature baby, vascular calcification. VALACYCLOVIR dosage: unknown. Patient recovered.

Valacyclovir Side Effects Report #5468195-9
Consumer or non-health professional from FRANCE reported VALACYCLOVIR problem on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: amniocentesis abnormal, congenital anomaly, foetal disorder, nervous system disorder, premature baby, vascular calcification, viral load increased. VALACYCLOVIR dosage: unknown. Patient recovered.

Valacyclovir Side Effects Report #5468197-2
VALACYCLOVIR problem was reported by a Consumer or non-health professional from FRANCE on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: congenital central nervous system anomaly, foetal disorder, premature baby, splenomegaly. VALACYCLOVIR dosage: unknown. Patient recovered.

Valacyclovir Side Effects Report #5468199-6
Consumer or non-health professional from FRANCE reported VALACYCLOVIR problem on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: abortion induced, brain damage, congenital central nervous system anomaly, congenital cerebral cyst, foetal disorder. VALACYCLOVIR dosage: unknown. Patient recovered.

Valacyclovir Side Effects Report #5468207-2
VALACYCLOVIR problem was reported by a Consumer or non-health professional from FRANCE on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: abortion induced, brain damage, foetal disorder. VALACYCLOVIR dosage: unknown. During the same period patient was treated with LIGNOCAINE HYDROCHLORIDE, MIFEPRISTONE, MISOPROSTOL. Patient recovered.

Valacyclovir Side Effects Report #5468305-3
Consumer or non-health professional from FRANCE reported VALACYCLOVIR problem on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: abortion induced, amniocentesis abnormal, brain damage, cerebral calcification, congenital anomaly, congenital infection, gastrointestinal disorder, viral load increased. VALACYCLOVIR dosage: unknown. Patient recovered.

Valacyclovir Side Effects Report #5468307-7
VALACYCLOVIR problem was reported by a Consumer or non-health professional from FRANCE on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: abortion induced, brain damage, foetal cerebrovascular disorder, foetal disorder, ultrasound antenatal screen abnormal. VALACYCLOVIR dosage: unknown. During the same period patient was treated with LIGNOCAINE HYDROCHLORIDE, MIREPRISTONE, MISOPROSTOL. Patient recovered.

Valacyclovir Side Effects Report #5468309-0
Consumer or non-health professional from FRANCE reported VALACYCLOVIR problem on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: amniocentesis abnormal, cardiomyopathy, cerebral calcification, congenital anomaly, congenital cytomegalovirus infection, deafness unilateral, foetal growth retardation, hepatic calcification. VALACYCLOVIR dosage: unknown. Patient recovered.

Valacyclovir Side Effects Report #5468322-3
VALACYCLOVIR problem was reported by a Consumer or non-health professional from FRANCE on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: congenital anomaly, microcephaly. VALACYCLOVIR dosage: unknown. Patient died.

Valacyclovir Side Effects Report #5468378-8
Consumer or non-health professional from FRANCE reported VALACYCLOVIR problem on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: abortion induced. VALACYCLOVIR dosage: unknown. During the same period patient was treated with LIGNOCAINE HYDROCHLORIDE, MIFEPRISTONE, MISOPROSTOL. Patient recovered.

Valacyclovir Side Effects Report #5468675-6
VALACYCLOVIR problem was reported by a Health Professional from FRANCE on Sept 10, 2007. Female patient was diagnosed with cytomegalovirus infection and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: abortion induced, cerebral ventricle dilatation, congenital brain damage, congenital hepatomegaly, foetal disorder, microcephaly, ultrasound scan abnormal, vascular calcification. VALACYCLOVIR dosage: unknown. Patient recovered.

Valacyclovir Side Effects Report #5381993-5
Physician from JAPAN reported VALACYCLOVIR problem on July 05, 2007. Male patient, 57 years of age, was diagnosed with herpes zoster and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: deafness unilateral, dysarthria, logorrhoea, sensory disturbance. VALACYCLOVIR dosage: 1000MG PER DAY. Patient recovered.

Valacyclovir Side Effects Report #5397689-X
VALACYCLOVIR problem was reported by a Consumer or non-health professional from JAPAN on July 10, 2007. Female patient was diagnosed with herpes zoster and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: anorexia, coordination abnormal, fatigue, gastritis, hot flush, pallor, pancytopenia, rash, renal disorder. VALACYCLOVIR dosage: 1000 MG/THREE TIMES PER DAY/ORAL. Patient recovered.

Valacyclovir Side Effects Report #5381993-5
Physician from JAPAN reported VALACYCLOVIR problem on July 05, 2007. Male patient, 57 years of age, was diagnosed with herpes zoster and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: deafness unilateral, dysarthria, logorrhoea, sensory disturbance. VALACYCLOVIR dosage: 1000MG PER DAY. Patient recovered.

Valacyclovir Side Effects Report #5397689-X
VALACYCLOVIR problem was reported by a Consumer or non-health professional from JAPAN on July 10, 2007. Female patient was diagnosed with herpes zoster and was treated with VALACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: anorexia, coordination abnormal, fatigue, gastritis, hot flush, pallor, pancytopenia, rash, renal disorder. VALACYCLOVIR dosage: 1000 MG/THREE TIMES PER DAY/ORAL. Patient recovered.


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dyskinesia, dysphemia, tremor, ear infection, headache, hepatic lesion, lymphadenopathy, panic attack, pruritus, sarcoidosis, , was diagnosed with genital herpes and was diagnosed with herpes zoster, cardiac disorder and was diagnosed with herpes virus infection, encephalitis herpes and