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Acyclovir Adverse Events Reported to the FDA Over Time

How are Acyclovir adverse event reports trending over time?

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

Most Common Acyclovir Adverse Events Reported to the FDA

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

Renal Failure Acute
204 (1.9%)
Drug Ineffective
167 (1.55%)
Pyrexia
131 (1.22%)
Vomiting
105 (.98%)
Confusional State
98 (.91%)
Rash
97 (.9%)
Herpes Zoster
96 (.89%)
Blood Creatinine Increased
93 (.87%)
Hepatotoxicity
89 (.83%)
Nausea
89 (.83%)
Diarrhoea
84 (.78%)
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Neutropenia
84 (.78%)
Neurotoxicity
82 (.76%)
Renal Failure
72 (.67%)
Renal Impairment
71 (.66%)
Malaise
70 (.65%)
Death
67 (.62%)
Drug Interaction
61 (.57%)
Dyspnoea
60 (.56%)
Fatigue
59 (.55%)
Somnolence
57 (.53%)
Convulsion
55 (.51%)
Dilatation Intrahepatic Duct Acquir...
55 (.51%)
Blood Bilirubin Increased
54 (.5%)
Dizziness
54 (.5%)
Liver Function Test Abnormal
54 (.5%)
Alanine Aminotransferase Increased
53 (.49%)
Dysarthria
53 (.49%)
Hallucination
52 (.48%)
Headache
52 (.48%)
Hypotension
49 (.46%)
Pruritus
49 (.46%)
Sepsis
49 (.46%)
Abdominal Pain
48 (.45%)
Agitation
48 (.45%)
Oedema
48 (.45%)
Anaemia
47 (.44%)
Aphasia
47 (.44%)
Encephalopathy
46 (.43%)
Febrile Neutropenia
46 (.43%)
Hallucination, Visual
46 (.43%)
Arthralgia
45 (.42%)
Nephropathy Toxic
44 (.41%)
Thrombocytopenia
44 (.41%)
Mental Status Changes
43 (.4%)
Blood Urea Increased
41 (.38%)
Drug Exposure During Pregnancy
41 (.38%)
Haemodialysis
41 (.38%)
Rash Maculo-papular
41 (.38%)
Erythema
40 (.37%)
Pneumonia
39 (.36%)
Respiratory Failure
39 (.36%)
Blood Alkaline Phosphatase Increase...
38 (.35%)
Cytomegalovirus Infection
38 (.35%)
Dehydration
38 (.35%)
Pain
38 (.35%)
Asthenia
37 (.34%)
Ataxia
37 (.34%)
Condition Aggravated
37 (.34%)
Gait Disturbance
37 (.34%)
Overdose
37 (.34%)
Venoocclusive Liver Disease
37 (.34%)
Encephalitis Herpes
36 (.34%)
Haemoglobin Decreased
36 (.34%)
Drug Toxicity
35 (.33%)
Coma
34 (.32%)
Angioedema
33 (.31%)
Disorientation
32 (.3%)
Drug Hypersensitivity
32 (.3%)
Encephalitis
30 (.28%)
Pain In Extremity
30 (.28%)
Aspartate Aminotransferase Increase...
29 (.27%)
Multi-organ Failure
29 (.27%)
Toxic Epidermal Necrolysis
29 (.27%)
Coordination Abnormal
28 (.26%)
Drug Resistance
28 (.26%)
Leukopenia
28 (.26%)
Psychotic Disorder
28 (.26%)
Graft Versus Host Disease
27 (.25%)
Herpes Simplex
27 (.25%)
Muscular Weakness
27 (.25%)
Rash Erythematous
27 (.25%)
Stevens-johnson Syndrome
27 (.25%)
Vision Blurred
27 (.25%)
Abdominal Distension
26 (.24%)
Altered State Of Consciousness
26 (.24%)
Back Pain
26 (.24%)
Herpes Virus Infection
26 (.24%)
Hypertension
26 (.24%)
Palmar-plantar Erythrodysaesthesia ...
26 (.24%)
Skin Toxicity
26 (.24%)
Tremor
26 (.24%)
Loss Of Consciousness
25 (.23%)
Nervous System Disorder
25 (.23%)
Alopecia
24 (.22%)
Bradycardia
24 (.22%)
Hyponatraemia
24 (.22%)
Myalgia
24 (.22%)
Paraesthesia
24 (.22%)
Platelet Count Decreased
24 (.22%)
Sinoatrial Block
24 (.22%)

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This graph shows the top adverse events submitted to the FDA for Acyclovir, 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 Acyclovir 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 Acyclovir

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

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This graph shows the top categories of adverse events submitted to the FDA for Acyclovir, 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 Acyclovir 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.

Common Uses of Acyclovir According to Those Reporting Adverse Events

Why are people taking Acyclovir, according to those reporting adverse events to the FDA?

Antiviral Prophylaxis
999
Prophylaxis
884
Drug Use For Unknown Indication
684
Product Used For Unknown Indication
683
Herpes Zoster
645
Infection Prophylaxis
413
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Herpes Virus Infection
263
Herpes Simplex
257
Genital Herpes
143
Oral Herpes
108
Encephalitis Herpes
84
Encephalitis
60
Varicella
57
Infection
50
Antiviral Treatment
38
Viral Infection
37
Meningitis
36
Rash
26
Ill-defined Disorder
26
Necrotising Retinitis
25
Pyrexia
24
Hiv Infection
24
Encephalitis Viral
21
Antibiotic Prophylaxis
21
Oral Infection
17
Herpes Ophthalmic
17
Meningoencephalitis Herpetic
16
Multiple Sclerosis
16
Chemotherapy
13
Facial Palsy
13
Cytomegalovirus Infection
13
Meningitis Viral
13
Keratitis Herpetic
11
Retinal Disorder
10
Skin Lesion
10
Herpes Zoster Ophthalmic
9
Graft Versus Host Disease
9
Bone Marrow Transplant
9
Epstein-barr Virus Infection
8
Viith Nerve Paralysis
8
Blister
8
Pain
8
Eye Infection Viral
7
Urinary Tract Infection
7
Evidence Based Treatment
7
Supportive Care
7
Neutropenia
7
Pneumonia
6
Antifungal Prophylaxis
6
Chronic Lymphocytic Leukaemia
6
Stomatitis
6

Drug Labels

LabelLabelerEffective
AcyclovirMylan Pharmaceuticals Inc.11-FEB-10
AcyclovirPD-Rx Pharmaceuticals, Inc.11-FEB-10
AcyclovirBedford Laboratories06-APR-10
AcyclovirDAVA Pharmaceuticals, Inc.14-APR-10
AcyclovirActavis Mid Atlantic LLC12-MAY-10
Acyclovir Heritage Pharmaceuticals, Inc.21-MAY-10
AcyclovirHi-Tech Pharmacal Co., Inc.16-JUN-10
AcyclovirPhysicians Total Care, Inc.09-JUL-10
AcyclovirMajor Pharmaceuticals13-JUL-10
AcyclovirUDL Laboratories, Inc.23-JUL-10
AcyclovirApotex Corp.10-DEC-10
AcyclovirBoscogen, Inc.05-JAN-11
AcyclovirRebel Distributors Corp05-JAN-11
ZoviraxBTA PHARMACEUTICALS INC01-FEB-11
ZoviraxBTA PHARMACEUTICALS INC01-FEB-11
AcyclovirStat Rx USA10-FEB-11
Acyclovir AvPAK10-MAR-11
Acyclovir AvKARE, Inc.10-MAR-11
AcyclovirBryant Ranch Prepack28-MAR-11
AcyclovirBlenheim Pharmacal, Inc.29-APR-11
AcyclovirBlenheim Pharmacal, Inc.29-APR-11
AcyclovirBlenheim Pharmacal, Inc.29-APR-11
AcyclovirREMEDYREPACK INC. 09-MAY-11
AcyclovirREMEDYREPACK INC. 09-MAY-11
AcyclovirREMEDYREPACK INC. 16-MAY-11
AcyclovirPreferred Pharmaceuticals, Inc09-JUN-11
AcyclovirRedPharm Drug Inc.30-JUN-11
AcyclovirGolden State Medical Supply, Inc.01-JUL-11
AcyclovirREMEDYREPACK INC. 13-JUL-11
AcyclovirREMEDYREPACK INC. 14-JUL-11
AcyclovirREMEDYREPACK INC. 14-JUL-11
AcyclovirREMEDYREPACK INC. 28-JUL-11
AcyclovirREMEDYREPACK INC. 01-AUG-11
AcyclovirREMEDYREPACK INC. 20-SEP-11
AcyclovirH.J. Harkins Company, Inc.27-OCT-11
AcyclovirREMEDYREPACK INC. 06-DEC-11
AcyclovirPD-Rx Pharmaceuticals, Inc.07-DEC-11
AcyclovirPD-Rx Pharmaceuticals, Inc.07-DEC-11
AcyclovirGolden State Medical Supply, Inc.09-JAN-12
AcyclovirGolden State Medical Supply, Inc.09-JAN-12
AcyclovirAPP Pharmaceuticals, LLC10-JAN-12
ZoviraxRebel Distributors Corp09-FEB-12
AcyclovirRebel Distributors Corp04-APR-12
AcyclovirCarlsbad Technology, Inc.05-APR-12
Acyclovir PD-Rx Pharmaceuticals, Inc.05-APR-12
AcyclovirApotex Corp.09-APR-12
ZoviraxValeant Pharmaceuticals North America LLC09-MAY-12
ZoviraxValeant Pharmaceuticals North America LLC09-MAY-12
AcyclovirCarlsbad Technology, Inc.12-JUN-12
XereseValeant Pharmaceuticals North America LLC22-JUN-12
AcyclovirPreferred Pharmaceuticals, Inc.27-JUL-12
AcyclovirMylan Pharmaceuticals Inc.31-JUL-12
AcyclovirAPP Pharmaceuticals, LLC15-AUG-12
AcyclovirREMEDYREPACK INC. 23-AUG-12
AcyclovirAidarex Pharmaceuticals LLC10-SEP-12
AcyclovirPhysicians Total Care, Inc.25-SEP-12
AcyclovirOceanside Pharmaceuticals03-OCT-12
AcyclovirPreferred Pharmaceuticals, Inc03-OCT-12
AcyclovirBryant Ranch Prepack18-JAN-13
AcyclovirBryant Ranch Prepack18-JAN-13
AcyclovirTeva Pharmaceuticals USA Inc08-FEB-13
AcyclovirREMEDYREPACK INC. 21-FEB-13
AcyclovirREMEDYREPACK INC. 27-FEB-13
AcyclovirMylan Pharmaceuticals Inc.28-FEB-13
AcyclovirCardinal Health06-MAR-13
ZoviraxGlaxoSmithKline LLC11-MAR-13
AcyclovirPreferred Pharmaceuticals, Inc.26-MAR-13
AcyclovirPreferred Pharmaceuticals, Inc26-MAR-13
AcyclovirREMEDYREPACK INC. 03-APR-13
AcyclovirREMEDYREPACK INC. 05-APR-13

Acyclovir Case Reports

What Acyclovir safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Acyclovir. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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