VALACYCLOVIR

Valacyclovir Adverse Events Reported to the FDA Over Time

How are Valacyclovir adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Valacyclovir, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Valacyclovir is flagged as the suspect drug causing the adverse event.

Most Common Valacyclovir Adverse Events Reported to the FDA

What are the most common Valacyclovir adverse events reported to the FDA?

Drug Ineffective	971 (3.3%)
Renal Failure Acute	822 (2.8%)
Dizziness	641 (2.18%)
Nausea	622 (2.12%)
Dysarthria	521 (1.77%)
Blood Creatinine Increased	506 (1.72%)
Altered State Of Consciousness	500 (1.7%)
Depressed Level Of Consciousness	493 (1.68%)
Vomiting	480 (1.63%)
Encephalopathy	415 (1.41%)
Headache	406 (1.38%)
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Blood Urea Increased	363 (1.23%)
Malaise	353 (1.2%)
Hallucination	340 (1.16%)
Delirium	312 (1.06%)
Pyrexia	311 (1.06%)
Overdose	295 (1%)
Gait Disturbance	291 (.99%)
Nervous System Disorder	286 (.97%)
Rash	286 (.97%)
Confusional State	265 (.9%)
Restlessness	238 (.81%)
Somnolence	234 (.8%)
Decreased Appetite	229 (.78%)
Herpes Virus Infection	228 (.78%)
Speech Disorder	228 (.78%)
Asthenia	223 (.76%)
Renal Failure	218 (.74%)
Renal Impairment	210 (.71%)
Disorientation	205 (.7%)
Diarrhoea	202 (.69%)
Pain	192 (.65%)
Anorexia	190 (.65%)
Drug Exposure During Pregnancy	186 (.63%)
Feeling Abnormal	180 (.61%)
Pruritus	173 (.59%)
Fatigue	162 (.55%)
Dyslalia	159 (.54%)
Herpes Simplex	144 (.49%)
Renal Disorder	144 (.49%)
Abnormal Behaviour	134 (.46%)
Muscular Weakness	134 (.46%)
Herpes Zoster	132 (.45%)
Dehydration	130 (.44%)
Tremor	128 (.44%)
Dyspnoea	126 (.43%)
Hallucination, Visual	123 (.42%)
Abdominal Pain	118 (.4%)
Urine Output Decreased	117 (.4%)
Convulsion	116 (.39%)
Psychiatric Symptom	113 (.38%)
Insomnia	111 (.38%)
Agitation	107 (.36%)
Dyskinesia	103 (.35%)
Abdominal Pain Upper	97 (.33%)
C-reactive Protein Increased	92 (.31%)
Ill-defined Disorder	92 (.31%)
Urticaria	92 (.31%)
Loss Of Consciousness	90 (.31%)
Erythema	89 (.3%)
Alanine Aminotransferase Increased	88 (.3%)
Condition Aggravated	87 (.3%)
Hypersensitivity	86 (.29%)
Hypoaesthesia	84 (.29%)
Back Pain	83 (.28%)
Drug Interaction	83 (.28%)
Alopecia	82 (.28%)
Aspartate Aminotransferase Increase...	82 (.28%)
Oedema Peripheral	78 (.27%)
Paraesthesia	76 (.26%)
Blood Pressure Increased	75 (.26%)
Delusion	74 (.25%)
Thrombocytopenia	74 (.25%)
Blister	73 (.25%)
Dysstasia	72 (.24%)
Eating Disorder	72 (.24%)
Therapeutic Response Unexpected	72 (.24%)
Abasia	71 (.24%)
Fall	71 (.24%)
Haemodialysis	71 (.24%)
Anxiety	70 (.24%)
Drug Toxicity	70 (.24%)
Oral Herpes	69 (.23%)
Hepatic Enzyme Increased	66 (.22%)
Aphasia	63 (.21%)
Dysphagia	62 (.21%)
Vision Blurred	60 (.2%)
Platelet Count Decreased	59 (.2%)
Depression	58 (.2%)
Swelling Face	58 (.2%)
Liver Disorder	57 (.19%)
Toxic Encephalopathy	57 (.19%)
Anaemia	56 (.19%)
Product Substitution Issue	56 (.19%)
Coordination Abnormal	55 (.19%)
Mental Disorder	55 (.19%)
Arthralgia	54 (.18%)
Blood Potassium Increased	54 (.18%)
Dysuria	54 (.18%)
Pneumonia	54 (.18%)
Urinary Retention	54 (.18%)

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This graph shows the top adverse events submitted to the FDA for Valacyclovir, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Valacyclovir is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Valacyclovir

What are the most common Valacyclovir adverse events reported to the FDA?

Neurological	4139 (14.08%)
Gastrointestinal Signs	1577 (5.36%)
Renal Disorders	1573 (5.35%)
Epidermal And Dermal Conditions	1383 (4.7%)
Therapeutic And Nontherapeutic Effe...	1310 (4.46%)
Renal And Urinary Tract Investigati...	1123 (3.82%)
Deliria	782 (2.66%)
Viral Infectious	733 (2.49%)
Disturbances In Thinking	597 (2.03%)
Encephalopathies	505 (1.72%)
Medication Errors	485 (1.65%)
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Appetite And General Nutritional	460 (1.56%)
Headaches	437 (1.49%)
Hematology Investigations	397 (1.35%)
Hepatobiliary	374 (1.27%)
Respiratory	372 (1.27%)
Movement Disorders	368 (1.25%)
Infections - Pathogen Unspecified	355 (1.21%)
Body Temperature Conditions	323 (1.1%)
Urinary Tract Signs	310 (1.05%)
Hepatic And Hepatobiliary	306 (1.04%)
Chemical Injury And Poisoning	287 (.98%)
Gastrointestinal Motility And Defec...	274 (.93%)
Changes In Physical Activity	264 (.9%)
Muscle	264 (.9%)
Electrolyte And Fluid Balance Condi...	257 (.87%)
Psychiatric And Behavioural Symptom...	253 (.86%)
Anxiety Disorders	248 (.84%)
Musculoskeletal And Connective Tiss...	220 (.75%)
Oral Soft Tissue Conditions	217 (.74%)
Cardiac And Vascular Investigations	207 (.7%)
Injuries	186 (.63%)
White Blood Cell	176 (.6%)
Vision	175 (.6%)
Skin Appendage Conditions	172 (.58%)
Seizures	168 (.57%)
Water, Electrolyte And Mineral	162 (.55%)
Allergic Conditions	154 (.52%)
Mental Impairment	154 (.52%)
Central Nervous System Vascular	148 (.5%)
Sleep Disorders	147 (.5%)
Protein And Chemistry Analyses	142 (.48%)
Cardiac Arrhythmias	133 (.45%)
Mood Disorders	133 (.45%)
Anemias Nonhemolytic And Marrow Dep...	126 (.43%)
Product Quality Issues	115 (.39%)
Enzyme	113 (.38%)
Angiedema And Urticaria	111 (.38%)
Hematological And Lymphoid Tissue T...	104 (.35%)
Gastrointestinal Hemorrhages	103 (.35%)
Psychiatric	102 (.35%)
Joint	96 (.33%)
Personality Disorders	95 (.32%)
Platelet	92 (.31%)
Ocular Infections, Irritations And ...	90 (.31%)
Physical Examination Topics	84 (.29%)
Metabolic, Nutritional And Blood Ga...	82 (.28%)
Communication Disorders	78 (.27%)
Lifestyle Issues	78 (.27%)
Inner Ear And Viiith Cranial Nerve	77 (.26%)
Depressed Mood Disorders	76 (.26%)
Eating Disorders	75 (.26%)
Decreased And Nonspecific Blood Pre...	74 (.25%)
Bacterial Infectious	73 (.25%)
Fungal Infectious	71 (.24%)
Cardiac Disorder Signs	68 (.23%)
Eye	66 (.22%)
Nephropathies	64 (.22%)
Suicidal And Self-injurious Behavio...	63 (.21%)
Toxicology And Therapeutic Drug Mon...	61 (.21%)
Skin Vascular Abnormalities	60 (.2%)
Vulvovaginal Disorders	53 (.18%)
Hearing	51 (.17%)
Neurological, Special Senses And Ps...	51 (.17%)
Tongue Conditions	51 (.17%)
Gastrointestinal Conditions	50 (.17%)
Glucose Metabolism Disorders	49 (.17%)
Fatal Outcomes	47 (.16%)
Lower Respiratory Tract Disorders	46 (.16%)
Upper Respiratory Tract Disorders	44 (.15%)
Vascular	44 (.15%)
Vascular Hypertensive	42 (.14%)
Central Nervous System Infections A...	41 (.14%)
Menstrual Cycle And Uterine Bleedin...	39 (.13%)
Ocular Neuromuscular	39 (.13%)
Salivary Gland Conditions	39 (.13%)
Spleen, Lymphatic And Reticulendoth...	37 (.13%)
Abortions And Stillbirth	36 (.12%)
Acid-base	36 (.12%)
Obstetric And Gynecological Therape...	34 (.12%)
Cranial Nerve Disorders	33 (.11%)
Microbiology And Serology	33 (.11%)
Pleural	33 (.11%)
Therapeutic Procedures And Supporti...	33 (.11%)
Dental And Gingival Conditions	32 (.11%)
Peripheral Neuropathies	30 (.1%)
Reproductive Tract	30 (.1%)
Schizophrenia And Other Psychotic	30 (.1%)
Gastrointestinal Inflammatory Condi...	29 (.1%)
Heart Failures	29 (.1%)
Manic And Bipolar Mood Disorders	28 (.1%)

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This graph shows the top categories of adverse events submitted to the FDA for Valacyclovir, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Valacyclovir is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.