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RETROVIR

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Retrovir Adverse Events Reported to the FDA Over Time

How are Retrovir adverse event reports trending over time?

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

Most Common Retrovir Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
575 (8.81%)
Anaemia
153 (2.34%)
Premature Baby
138 (2.11%)
Caesarean Section
78 (1.2%)
Pregnancy
77 (1.18%)
Abdominal Distension
65 (1%)
Maternal Drugs Affecting Foetus
59 (.9%)
Cardiac Murmur
55 (.84%)
Immune Reconstitution Syndrome
53 (.81%)
Pyrexia
50 (.77%)
Nausea
49 (.75%)
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Thrombocytopenia
49 (.75%)
Cryptorchism
48 (.74%)
Congenital Anomaly
46 (.7%)
Diarrhoea
44 (.67%)
Vomiting
42 (.64%)
Abortion Spontaneous
38 (.58%)
Aspartate Aminotransferase Increase...
38 (.58%)
Abdominal Hernia
36 (.55%)
Bone Marrow Failure
35 (.54%)
Patent Ductus Arteriosus
35 (.54%)
Alanine Aminotransferase Increased
34 (.52%)
Lactic Acidosis
34 (.52%)
Neutropenia
32 (.49%)
Pancytopenia
31 (.48%)
Premature Rupture Of Membranes
31 (.48%)
Respiratory Distress
29 (.44%)
Premature Labour
28 (.43%)
Stillbirth
28 (.43%)
Gamma-glutamyltransferase Increased
27 (.41%)
Leukopenia
27 (.41%)
Liver Disorder
27 (.41%)
Diabetes Mellitus
26 (.4%)
Convulsion
25 (.38%)
Jaundice
25 (.38%)
Rash
25 (.38%)
Blood Lactic Acid Increased
24 (.37%)
Accidental Overdose
23 (.35%)
Anaemia Macrocytic
23 (.35%)
Anaemia Neonatal
23 (.35%)
Atrial Septal Defect
23 (.35%)
Foetal Growth Retardation
23 (.35%)
Polydactyly
23 (.35%)
Small For Dates Baby
23 (.35%)
Weight Decreased
23 (.35%)
Fatigue
22 (.34%)
Intra-uterine Death
22 (.34%)
Malaise
22 (.34%)
Necrotising Enterocolitis Neonatal
22 (.34%)
Abdominal Pain
21 (.32%)
Cleft Lip And Palate
21 (.32%)
Ascites
20 (.31%)
Hypotonia
20 (.31%)
Blood Alkaline Phosphatase Increase...
19 (.29%)
Blood Bilirubin Increased
19 (.29%)
Blood Creatine Phosphokinase Increa...
19 (.29%)
Hypoglycaemia
19 (.29%)
Ventricular Septal Defect
19 (.29%)
Depression
18 (.28%)
Dyspnoea
18 (.28%)
Foetal Distress Syndrome
18 (.28%)
Haematochezia
18 (.28%)
Haemoglobin Decreased
18 (.28%)
Hepatic Steatosis
18 (.28%)
Tricuspid Valve Incompetence
18 (.28%)
Trisomy 21
18 (.28%)
Hyperlactacidaemia
17 (.26%)
Hypoplastic Right Heart Syndrome
17 (.26%)
Hypospadias
17 (.26%)
Neonatal Disorder
17 (.26%)
Pallor
17 (.26%)
Renal Failure
17 (.26%)
Dehydration
16 (.25%)
General Physical Health Deteriorati...
16 (.25%)
Headache
16 (.25%)
Hepatic Function Abnormal
16 (.25%)
Live Birth
16 (.25%)
Hepatomegaly
15 (.23%)
Pulmonary Hypertension
15 (.23%)
Vitamin B12 Deficiency
15 (.23%)
Anorexia
14 (.21%)
Back Pain
14 (.21%)
Congenital Cytomegalovirus Infectio...
14 (.21%)
Cough
14 (.21%)
Herpes Zoster
14 (.21%)
Metabolic Acidosis
14 (.21%)
Necrotising Colitis
14 (.21%)
Neonatal Respiratory Distress Syndr...
14 (.21%)
Neuropathy Peripheral
14 (.21%)
Spastic Paraplegia
14 (.21%)
Spinal Cord Disorder
14 (.21%)
Transaminases Increased
14 (.21%)
Congenital Hydronephrosis
13 (.2%)
Death Neonatal
13 (.2%)
Decreased Appetite
13 (.2%)
Fungal Infection
13 (.2%)
Subacute Combined Cord Degeneration
13 (.2%)
Tachycardia
13 (.2%)
Tremor
13 (.2%)
Venous Thrombosis Limb
13 (.2%)
White Blood Cell Count Decreased
13 (.2%)

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

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

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This graph shows the top categories of adverse events submitted to the FDA for Retrovir, 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 Retrovir 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 Retrovir According to Those Reporting Adverse Events

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

Hiv Infection
1107
Antiviral Prophylaxis
301
Acquired Immunodeficiency Syndrome
93
Antiretroviral Therapy
91
Drug Exposure During Pregnancy
79
Drug Use For Unknown Indication
54
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Maternal Exposure Timing Unspecifie...
53
Prophylaxis Against Hiv Infection
44
Hiv Test Positive
41
Antiviral Treatment
40
Maternal Exposure During Pregnancy
32
Prophylaxis
25
Product Used For Unknown Indication
23
Vertical Infection Transmission
14
Human Immunodeficiency Virus Transm...
14
Infection Prophylaxis
6
Systemic Antiviral Treatment
5
Ill-defined Disorder
4
Viral Infection
3
Accidental Needle Stick
3
Hepatitis C
2
Hiv Test
2
Exposure To Communicable Disease
2
Asymptomatic Hiv Infection
2
Congenital Hiv Infection
2
Human T-cell Lymphotropic Virus Typ...
1
Acute Hiv Infection
1
Hiv Infection Cdc Category A2
1
Retroviral Infection
1
Medication Error
1
Tropical Spastic Paresis
1
Hyperbilirubinaemia
1
Persistent Generalised Lymphadenopa...
1

Drug Labels

LabelLabelerEffective
RetrovirGlaxoSmithKline LLC14-MAR-11
RetrovirGlaxoSmithKline LLC13-JUL-11
RetrovirViiV Healthcare Company31-MAY-12
RetrovirViiV Healthcare Company31-MAY-12
RetrovirPhysicians Total Care, Inc.27-MAR-13

Retrovir Case Reports

What Retrovir 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 Retrovir. 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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