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NEVIRAPINE

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Nevirapine Adverse Events Reported to the FDA Over Time

How are Nevirapine adverse event reports trending over time?

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

Most Common Nevirapine Adverse Events Reported to the FDA

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

Hiv Infection
557 (4.13%)
Drug Exposure During Pregnancy
466 (3.46%)
Drug Ineffective
316 (2.34%)
Drug Resistance
298 (2.21%)
Viral Mutation Identified
296 (2.2%)
Death
255 (1.89%)
Pyrexia
217 (1.61%)
Immune Reconstitution Syndrome
193 (1.43%)
Anaemia
172 (1.28%)
Human Immunodeficiency Virus Transm...
160 (1.19%)
Rash
141 (1.05%)
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Vomiting
134 (.99%)
Hepatotoxicity
118 (.88%)
Sepsis
115 (.85%)
Caesarean Section
101 (.75%)
Maternal Drugs Affecting Foetus
101 (.75%)
Lipodystrophy Acquired
100 (.74%)
Pneumonia
100 (.74%)
Alanine Aminotransferase Increased
93 (.69%)
Hiv Test Positive
93 (.69%)
Stillbirth
90 (.67%)
Pregnancy
87 (.65%)
Diarrhoea
85 (.63%)
Stevens-johnson Syndrome
82 (.61%)
Gastroenteritis
81 (.6%)
Cough
79 (.59%)
Lactic Acidosis
79 (.59%)
Tuberculosis
79 (.59%)
Neutropenia
78 (.58%)
Portal Hypertension
78 (.58%)
Nausea
75 (.56%)
Mitochondrial Toxicity
73 (.54%)
Eyelid Ptosis
69 (.51%)
Hepatic Failure
68 (.5%)
Hepatitis
68 (.5%)
Drug Interaction
67 (.5%)
Blood Hiv Rna Increased
64 (.47%)
Asthenia
60 (.45%)
Haemoglobin Decreased
59 (.44%)
Premature Baby
58 (.43%)
Diplopia
57 (.42%)
Weight Decreased
55 (.41%)
Abdominal Pain
53 (.39%)
Aspartate Aminotransferase Increase...
53 (.39%)
Lymphadenopathy
53 (.39%)
Malaise
53 (.39%)
Progressive External Ophthalmoplegi...
53 (.39%)
Abortion Spontaneous
50 (.37%)
Dyspnoea
50 (.37%)
Fatigue
49 (.36%)
Headache
49 (.36%)
Drug Toxicity
45 (.33%)
Vanishing Bile Duct Syndrome
45 (.33%)
Hyperlactacidaemia
43 (.32%)
Abortion Induced
42 (.31%)
Congenital Anomaly
42 (.31%)
Intra-uterine Death
42 (.31%)
Drug Hypersensitivity
41 (.3%)
Cd4 Lymphocytes Decreased
39 (.29%)
Hypersensitivity
39 (.29%)
Jaundice
39 (.29%)
Pallor
39 (.29%)
Neuropathy Peripheral
38 (.28%)
Ascites
37 (.27%)
Cardiac Malposition
36 (.27%)
Maternal Condition Affecting Foetus
36 (.27%)
Neonatal Disorder
36 (.27%)
Blood Bilirubin Increased
35 (.26%)
Portal Vein Thrombosis
34 (.25%)
Renal Failure Acute
34 (.25%)
Bronchopneumonia
33 (.24%)
Dehydration
33 (.24%)
Diaphragmatic Aplasia
33 (.24%)
Gastrointestinal Disorder
33 (.24%)
Hepatomegaly
33 (.24%)
Malaria
33 (.24%)
Nodular Regenerative Hyperplasia
33 (.24%)
Splenomegaly
33 (.24%)
Pain In Extremity
32 (.24%)
Pancreatitis
32 (.24%)
Portal Hypertensive Gastropathy
32 (.24%)
Rash Maculo-papular
32 (.24%)
Toxic Epidermal Necrolysis
32 (.24%)
Viral Load Increased
32 (.24%)
Confusional State
31 (.23%)
Hepatic Fibrosis
31 (.23%)
Hepatosplenomegaly
31 (.23%)
Agitation
30 (.22%)
Gamma-glutamyltransferase Increased
30 (.22%)
Hepatic Displacement
30 (.22%)
Infection
30 (.22%)
Small For Dates Baby
30 (.22%)
Exomphalos
29 (.22%)
Pulmonary Tuberculosis
29 (.22%)
Respiratory Distress
29 (.22%)
Myalgia
28 (.21%)
Pneumothorax
28 (.21%)
Pre-eclampsia
28 (.21%)
Varices Oesophageal
28 (.21%)
Vertical Infection Transmission
28 (.21%)
Blood Alkaline Phosphatase Increase...
27 (.2%)

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

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

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

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

Hiv Infection
2242
Human Immunodeficiency Virus Transm...
581
Prophylaxis
419
Prophylaxis Against Hiv Infection
290
Antiviral Prophylaxis
164
Drug Exposure During Pregnancy
103
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Acquired Immunodeficiency Syndrome
81
Drug Use For Unknown Indication
78
Antiretroviral Therapy
68
Hiv Test Positive
59
Product Used For Unknown Indication
26
Systemic Antiviral Treatment
20
Hepatitis B
15
Antiviral Treatment
12
Retroviral Infection
10
Maternal Exposure During Pregnancy
8
Hiv Infection Cdc Category C3
7
Hepatic Cirrhosis
5
Kaposis Sarcoma Aids Related
5
Maternal Exposure Timing Unspecifie...
4
Hiv Infection Who Clinical Stage I
3
Acute Hiv Infection
3
Pregnancy
3
Hepatitis C Virus Test
3
Hiv Antibody Positive
2
Hiv Test
2
Hiv Wasting Syndrome
2
Hiv Infection Who Clinical Stage Ii
2
Infection Prophylaxis
2
Hiv Carrier
2
Pneumocystis Jiroveci Infection
2
Hiv Infection Cdc Category A2
2
Hiv Infection Cdc Category B2
2
Death
1
Perinatal Hiv Infection
1
Hiv Infection Who Clinical Stage Iv
1
Drug Exposure Via Breast Milk
1
Hiv Infection Cdc Category A1
1
Drug Level
1
Hiv Infection Cdc Category C1
1
Hiv Infection Cdc Category B3
1
Tuberculosis
1
Hepatitis B Virus Test
1
Hiv Infection Cdc Group I
1
Viral Infection
1
Hiv Infection Cdc Category A3
1
Vertical Infection Transmission
1
Castlemans Disease
1
Local Antiviral Treatment
1

Drug Labels

LabelLabelerEffective
ViramuneState of Florida DOH Central Pharmacy21-MAY-10
NevirapineAmneal Pharmaceuticals, LLC30-NOV-11
Fluvoxamine MaleateGolden State Medical Supply, Inc.09-JAN-12
NevirapineGolden State Medical Supply, Inc.09-JAN-12
NevirapineMylan Pharmaceuticals Inc.11-JAN-12
NevirapineBRECKENRIDGE PHARMACEUTICAL, INC.01-MAR-12
NevirapineCipla Limited01-APR-12
NevirapineSeton Pharmaceuticals21-MAY-12
NevirapineRoxane Laboratories, Inc.21-MAY-12
NevirapineApotex Corp10-NOV-12
ViramuneBoehringer Ingelheim Pharmaceuticals, Inc.15-NOV-12
ViramuneBoehringer Ingelheim Pharmaceuticals Inc.16-NOV-12
NevirapineAurobindo Pharma Limited17-JAN-13
ViramunePhysicians Total Care, Inc.06-FEB-13
NevirapineAurobindo Pharma Limited26-FEB-13
NevirapineCamber Pharmaceuticals, Inc.20-MAR-13

Nevirapine Case Reports

What Nevirapine 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 Nevirapine. 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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