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Valtrex (Valacyclovir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Valtrex (Valacyclovir) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (388)
Death (9)
Life Threatening Events (12)
Disability (10)

Reports by Reaction Type

Renal Failure Acute (58)Altered State of Consciousness (49)Encephalopathy (42)Dysarthria (41)Blood Creatinine Increased (39)Renal Impairment (36)Dizziness (32)Blood Urea Increased (26)Drug Ineffective (25)Malaise (25)Decreased Appetite (25)Nausea (23)

Below are a few examples of reports where side effects / adverse reactions may be related to Valtrex (Valacyclovir). For a complete list or a specific selection of reports, please use the links above.

Possible Valtrex side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Pruritus, Hypersensitivity, Contusion, Chills, Headache, Herpes Zoster, Vascular Injury, Fatigue, Malaise, Tongue Disorder, Candidiasis, Scratch, Swelling Face, Vomiting, Tongue Oedema, Nausea, Anaemia, Hypoaesthesia, Rash, Dysgeusia, Diarrhoea, Feeling Abnormal, Influenza

Drug(s) suspected as cause:
PEG-Intron
    Dosage: unk unk, unknown
    Indication: Hepatitis C
    Start date: 2012-05-04

Rebetol
    Dosage: unk unk, unknown
    Indication: Hepatitis C
    Start date: 2012-05-04

Valtrex
    Dosage: unk unk, unknown
    Indication: Herpes Zoster

Victrelis
    Dosage: unk unk, unknown
    Indication: Hepatitis C
    Start date: 2012-06-01



Possible Valtrex side effects in 76 year old male

Reported by a pharmacist from Japan on 2012-08-22

Patient: 76 year old male

Reactions: Renal Failure, Altered State of Consciousness

Drug(s) suspected as cause:
Valtrex



Possible Valtrex side effects in female

Reported by a pharmacist from Japan on 2012-08-22

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Renal Impairment, Blood Urea Increased, Blood Electrolytes Abnormal, Altered State of Consciousness, Blood Creatinine Increased, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arasena-A
    Administration route: Topical
    Indication: Herpes Zoster
    Start date: 2012-06-26
    End date: 2012-06-30

Valtrex
    Dosage: 3000mg per day
    Administration route: Oral
    Indication: Herpes Zoster
    Start date: 2012-06-26
    End date: 2012-06-30

Other drugs received by patient: Amlodipine; Risperdal; Depas; Micardis



Possible Valtrex side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Valtrex



Possible Valtrex side effects in 62 year old female

Reported by a physician from Japan on 2012-08-20

Patient: 62 year old female, weighing 66.0 kg (145.2 pounds)

Reactions: Dysarthria, Overdose, Altered State of Consciousness, Loss of Consciousness, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex
    Dosage: 500mg per day
    Administration route: Oral
    Start date: 2011-04-26
    End date: 2011-04-27

Valtrex
    Dosage: 1000mg per day
    Administration route: Oral
    Indication: Herpes Zoster
    Start date: 2011-04-25
    End date: 2011-04-25

Other drugs received by patient: Tenormin; Mefenamic Acid; Adalat; Vitamin B12; Renagel; Alosenn; Cinacalcet Hydrochloride; Famotidine; Precipitated Calcium Carbonate



Possible Valtrex side effects in 90 year old female

Reported by a pharmacist from Japan on 2012-08-17

Patient: 90 year old female

Reactions: Overdose, Carotid Artery Occlusion, Cerebral Artery Occlusion, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex
    Dosage: 3000mg per day
    Administration route: Oral
    Indication: Herpes Zoster Oticus
    Start date: 2012-03-09
    End date: 2012-03-13

Valtrex
    Dosage: 1000mg per day
    Administration route: Oral
    Start date: 2012-03-14
    End date: 2012-03-16

Other drugs received by patient: Enalapril Maleate; Furosemide; Pursennid; Amlodipine; Voltaren; Aldactone; Tocopherol Concentrate CAP; Ferrous Citrate; Aspirin; Lipitor; Acetaminophen



Possible Valtrex side effects in 73 year old female

Reported by a consumer/non-health professional from Japan on 2012-08-15

Patient: 73 year old female

Reactions: Dysuria, Asthenia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Unknown Drug

Valtrex
    Dosage: 3000mg per day
    Administration route: Oral
    Indication: Herpes Zoster
    Start date: 2011-10-08
    End date: 2011-10-12



Possible Valtrex side effects in female

Reported by a physician from Japan on 2012-08-14

Patient: female

Reactions: Speech Disorder, Blood Urea Increased, Overdose, Vomiting, Nervous System Disorder, Blood Creatinine Increased, Renal Failure Acute, Thrombosis in Device

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex

Other drugs received by patient: Diclofenac Sodium



Possible Valtrex side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-13

Patient: male

Reactions: Affect Lability, Hallucination

Drug(s) suspected as cause:
Valtrex

Other drugs received by patient: Furosemide; Nesina; Clonazepam; Promac; Aspirin; Sigmart; Famotidine; Menest



Possible Valtrex side effects in 93 year old female

Reported by a physician from Japan on 2012-08-13

Patient: 93 year old female, weighing 37.0 kg (81.4 pounds)

Reactions: Hyperventilation, Soliloquy, Dyskinesia, Abnormal Behaviour, Encephalopathy, Somnolence, Logorrhoea

Drug(s) suspected as cause:
Valtrex



Possible Valtrex side effects in female

Reported by a physician from Japan on 2012-08-13

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Blood Urea Increased, Blood Potassium Increased, Dysarthria, Communication Disorder, Blood Uric Acid Increased, Nervous System Disorder, Asthenia, Blood Creatinine Increased, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex
    Dosage: 3000mg per day
    Administration route: Oral
    Indication: Herpes Zoster
    Start date: 2012-07-17
    End date: 2012-07-23

Zovirax
    Dosage: 250mg per day
    Indication: Herpes Zoster
    Start date: 2012-07-17
    End date: 2012-07-21

Other drugs received by patient: Atelec; Pravastatin Sodium; Losartan Potassium and Hydrochlorothiazide



Possible Valtrex side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09

Patient:

Reactions: Foetal Exposure During Pregnancy, Ventricular Septal Defect

Drug(s) suspected as cause:
Effexor
    Dosage: 75 mg, unk
    Indication: Depression
    Start date: 2007-01-01
    End date: 2010-11-30

PEG-Intron
    Dosage: unk
    Start date: 2009-01-01
    End date: 2010-06-04

Proventil
    Dosage: unk, prn
    Indication: Asthma

Ribavirin (+) Interferon Alfa-2B
    Dosage: unk
    Start date: 2009-01-01
    End date: 2010-06-04

Suboxone
    Dosage: 10 mg, unk
    Indication: Drug Dependence
    Start date: 2009-06-01
    End date: 2010-10-08

Subutex
    Dosage: 8 mg, unk
    Indication: Drug Dependence
    Start date: 2010-10-09

Valtrex
    Dosage: 1 g, unk
    Indication: Herpes Virus Infection
    Start date: 2011-04-19

Zoloft
    Dosage: 50 mg, unk
    Indication: Depression
    Start date: 2010-11-30

Other drugs received by patient: Vitamins (Unspecified)



Possible Valtrex side effects in female

Reported by a pharmacist from Japan on 2012-08-08

Patient: female

Reactions: Drug Level Increased, Heat Illness, Dehydration, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex

Other drugs received by patient: Acycril; Recalbon; Loxonin; Arasena-A; Amitriptyline HCL; Mucosta; Allegra; Epadel; Diflunisal; Uritos; Atorvastatin



Possible Valtrex side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 73 year old male

Reactions: Dysphagia, International Normalised Ratio Increased, General Physical Health Deterioration, Erosive Oesophagitis, Rash, International Normalised Ratio Fluctuation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Acyclovir
    Indication: Herpes Simplex
    Start date: 2012-06-07
    End date: 2012-06-18

Clindamycin
    Indication: Herpes Simplex
    Start date: 2012-06-07
    End date: 2012-06-18

Coumadin
    Dosage: 7.5mg unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-07

Valtrex
    Dosage: 500mg twice per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-17
    End date: 2012-06-23

Other drugs received by patient: Zovirax; Digoxin; Prednisone TAB; Bactroban; Amiodarone HCL; Omeprazole



Possible Valtrex side effects in male

Reported by a pharmacist from Japan on 2012-08-08

Patient: male

Reactions: Overdose, Depressed Level of Consciousness, Encephalopathy, Nervous System Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex

Other drugs received by patient: Warfarin Sodium; Furosemide; Aspirin; Rocaltrol



Possible Valtrex side effects in 76 year old female

Reported by a physician from Japan on 2012-08-06

Patient: 76 year old female

Reactions: Protein Urine Present, Blood Urine Present, Laboratory Test Abnormal, Renal Disorder

Drug(s) suspected as cause:
Valtrex

Other drugs received by patient: Adalat; Vitamin B12; Acetaminophen; Candesartan Cilexetil



Possible Valtrex side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient:

Reactions: Contusion, Hypersensitivity, Chills, Herpes Zoster, Vascular Injury, Face Oedema, Malaise, Tongue Disorder, Candidiasis, Scratch, Vomiting, Tongue Oedema, Rash, Hypoaesthesia, Dysgeusia, Diarrhoea, Feeling Abnormal, Influenza

Drug(s) suspected as cause:
PEG-Intron
    Dosage: unk unk, unknown
    Indication: Hepatitis C
    Start date: 2012-05-04

Ribavirin
    Dosage: unk unk, unknown
    Indication: Hepatitis C
    Start date: 2012-05-04

Valtrex
    Dosage: unk unk, unknown
    Indication: Herpes Zoster

Victrelis
    Dosage: unk unk, unknown
    Indication: Hepatitis C
    Start date: 2012-06-01



Possible Valtrex side effects in female

Reported by a physician from Japan on 2012-08-01

Patient: female, weighing 39.0 kg (85.8 pounds)

Reactions: Dizziness, Encephalopathy, Gait Disturbance, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex

Other drugs received by patient: Norvasc; Crestor; Precipitated Calcium Carbonate; Nalfurafine Hydrochloride



Possible Valtrex side effects in female

Reported by a physician from Japan on 2012-08-01

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Blood Urea Increased, Renal Impairment, Blood Electrolytes Abnormal, Altered State of Consciousness, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex

Other drugs received by patient: Risperdal; Amlodipine; Depas; Micardis; Arasena-A



Possible Valtrex side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: female

Reactions: Product Substitution Issue, Drug Effect Delayed

Drug(s) suspected as cause:
Valtrex



Possible Valtrex side effects in female

Reported by a physician from Japan on 2012-07-31

Patient: female, weighing 40.0 kg (88.0 pounds)

Reactions: Renal Disorder, Encephalitis, Cognitive Disorder, Delirium, Speech Disorder, Nervous System Disorder, Meningitis, Altered State of Consciousness, Renal Failure Acute

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Valtrex

Other drugs received by patient: Atenolol; Sermion; Alfarol; Tenormin; Amlodipine; Lansoprazole; Cefazolin Sodium



Possible Valtrex side effects in female

Reported by a consumer/non-health professional from Japan on 2012-07-31

Patient: female

Reactions: Abdominal Discomfort, Vulval Haemorrhage, Diarrhoea

Drug(s) suspected as cause:
Valtrex



Possible Valtrex side effects in female

Reported by a physician from Japan on 2012-07-31

Patient: female

Reactions: Dysarthria, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex
    Dosage: 3000mg per day
    Administration route: Oral
    Indication: Herpes Zoster
    Start date: 2012-07-17
    End date: 2012-07-23

Zovirax
    Dosage: 250mg per day
    Indication: Herpes Zoster
    Start date: 2012-07-17
    End date: 2012-07-21

Other drugs received by patient: Losartan Potassium and Hydrochlorothiazide; Atelec; Pravastatin Sodium



Possible Valtrex side effects in 24 year old female

Reported by a health professional (non-physician/pharmacist) from Argentina on 2012-07-30

Patient: 24 year old female

Reactions: Vaginal Haemorrhage

Drug(s) suspected as cause:
Valtrex



Possible Valtrex side effects in 74 year old female

Reported by a pharmacist from Japan on 2012-07-26

Patient: 74 year old female

Reactions: Thrombocytopenia, Leukopenia

Drug(s) suspected as cause:
Lipitor
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-12-01
    End date: 2011-01-01

Valtrex
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Diflucan; Medrol; Mucosta



Possible Valtrex side effects in female

Reported by a physician from Japan on 2012-07-26

Patient: female, weighing 47.0 kg (103.4 pounds)

Reactions: Renal Disorder, Blood Urea Increased, Myoglobin Urine Present, Blood Lactate Dehydrogenase Increased, Renal Impairment, Blood Uric Acid Increased, Dizziness, Coordination Abnormal, Myoglobin Blood Increased, Blood Creatinine Increased, Renal Failure Acute, Anuria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex

Other drugs received by patient: Paxil; Metoprolol Tartrate; Alendronate Sodium; Rocaltrol; Etizolam; Lansoprazole; Allopurinol; Adalat CC; Lipitor; Mobic; Dogmatyl



Possible Valtrex side effects in 71 year old female

Reported by a physician from Japan on 2012-07-25

Patient: 71 year old female, weighing 37.0 kg (81.4 pounds)

Reactions: Encephalopathy, CSF Cell Count Increased, Pyrexia, Speech Disorder, Dysstasia, Dizziness, Meningitis, Altered State of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex

Other drugs received by patient: Ceftriaxone



Possible Valtrex side effects in male

Reported by a physician from Japan on 2012-07-23

Patient: male

Reactions: Renal Impairment, Blood Urea Increased, Pneumonia, C-Reactive Protein Increased, Pleural Effusion, Altered State of Consciousness, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex
    Dosage: 3000mg per day
    Administration route: Oral
    Indication: Herpes Zoster
    Start date: 2012-05-19
    End date: 2012-05-21

Valtrex
    Dosage: 2000mg per day
    Administration route: Oral
    Start date: 2012-05-21
    End date: 2012-05-23

Other drugs received by patient: Mucodyne; Famotidine; Magmitt; Pantosin; Unasyn; Tamsulosin HCL



Possible Valtrex side effects in female

Reported by a physician from Japan on 2012-07-23

Patient: female

Reactions: Confusional State, Blood Urea Increased, Spleen Scan Abnormal, Kidney Enlargement, Renal Cyst, Blood Uric Acid Increased, Urinary Retention, Asthenia, Blood Creatinine Increased, Feeling Abnormal, Decreased Appetite, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Valtrex

Other drugs received by patient: Alprazolam; Airocool; Uniphyl; Asverin; Dogmatyl; Bunazosin Hydrochloride; Singulair; Mucosta; Alprazolam; Candesartan Cilexetil; Aspenon; Depas; Candesartan Cilexetil; Abilit



Possible Valtrex side effects in male

Reported by a physician from Japan on 2012-07-23

Patient: male

Reactions: Renal Failure, Encephalopathy, Altered State of Consciousness, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valtrex

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