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Aptivus Adverse Events Reported to the FDA Over Time

How are Aptivus adverse event reports trending over time?

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

Most Common Aptivus Adverse Events Reported to the FDA

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

Haemorrhage Intracranial
92 (3.32%)
Death
53 (1.91%)
Alanine Aminotransferase Increased
50 (1.8%)
Aspartate Aminotransferase Increase...
49 (1.77%)
Diarrhoea
48 (1.73%)
Exomphalos
48 (1.73%)
Bladder Agenesis
44 (1.59%)
Liver Function Test Abnormal
44 (1.59%)
Cloacal Exstrophy
32 (1.15%)
Lipodystrophy Acquired
32 (1.15%)
Cachexia
31 (1.12%)
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Caudal Regression Syndrome
31 (1.12%)
Convulsion
31 (1.12%)
Meningomyelocele
31 (1.12%)
Blood Iron Decreased
30 (1.08%)
Cerebral Haemorrhage
30 (1.08%)
Jaundice
30 (1.08%)
Meconium Stain
30 (1.08%)
Umbilical Cord Abnormality
30 (1.08%)
Anal Atresia
29 (1.05%)
Congenital Genital Malformation
29 (1.05%)
Gastrointestinal Disorder Congenita...
29 (1.05%)
Genitalia External Ambiguous
29 (1.05%)
Cytolytic Hepatitis
27 (.97%)
Gastrointestinal Malformation
25 (.9%)
Sepsis
24 (.86%)
Drug Ineffective
22 (.79%)
Drug Exposure During Pregnancy
21 (.76%)
Malnutrition
21 (.76%)
Mental Status Changes
21 (.76%)
Congenital Musculoskeletal Anomaly
20 (.72%)
Headache
20 (.72%)
Hepatitis
20 (.72%)
Liver Disorder
18 (.65%)
Cerebrovascular Accident
17 (.61%)
Immune Reconstitution Syndrome
17 (.61%)
Pyrexia
17 (.61%)
Blood Bilirubin Unconjugated Increa...
16 (.58%)
Fatigue
16 (.58%)
Hypertension
16 (.58%)
Meningitis Cryptococcal
16 (.58%)
Overdose
16 (.58%)
Portal Hypertension
16 (.58%)
Erythema
15 (.54%)
Gastrointestinal Disorder
15 (.54%)
Hepatotoxicity
15 (.54%)
Renal Failure Acute
15 (.54%)
Bilirubin Conjugated Increased
14 (.5%)
Cholestasis
14 (.5%)
Cytomegalovirus Infection
14 (.5%)
Encephalitis Viral
14 (.5%)
Haemarthrosis
14 (.5%)
Hepatic Cirrhosis
14 (.5%)
Transaminases Increased
14 (.5%)
Varices Oesophageal
14 (.5%)
Viral Load Increased
14 (.5%)
Asthenia
13 (.47%)
Blood Bilirubin Increased
13 (.47%)
Hepatic Enzyme Increased
13 (.47%)
Hydrocephalus
13 (.47%)
Nausea
13 (.47%)
Pulmonary Embolism
13 (.47%)
Tethered Cord Syndrome
13 (.47%)
Blood Pressure Increased
12 (.43%)
Drug Interaction
12 (.43%)
Pain In Extremity
12 (.43%)
Aids Dementia Complex
11 (.4%)
Cardiac Failure
11 (.4%)
Cerebellar Ataxia
11 (.4%)
Cerebral Haematoma
11 (.4%)
Dementia
11 (.4%)
Grand Mal Convulsion
11 (.4%)
Haematoma
11 (.4%)
Malaise
11 (.4%)
Anorexia
10 (.36%)
Hiv Infection
10 (.36%)
Premature Baby
10 (.36%)
Rash
10 (.36%)
Aspergillosis
9 (.32%)
Cerebral Infarction
9 (.32%)
Fall
9 (.32%)
Gamma-glutamyltransferase Increased
9 (.32%)
Gastritis
9 (.32%)
Lactic Acidosis
9 (.32%)
Musculoskeletal Deformity
9 (.32%)
Pulmonary Oedema
9 (.32%)
Respiratory Tract Infection Bacteri...
9 (.32%)
Subcutaneous Abscess
9 (.32%)
Vomiting
9 (.32%)
Weight Decreased
9 (.32%)
Blood Triglycerides Increased
8 (.29%)
Confusional State
8 (.29%)
Epistaxis
8 (.29%)
Hepatitis B
8 (.29%)
Hypersensitivity
8 (.29%)
Platelet Count Decreased
8 (.29%)
Premature Labour
8 (.29%)
Pruritus
8 (.29%)
Abortion Spontaneous
7 (.25%)
Aphasia
7 (.25%)
Arthralgia
7 (.25%)

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

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

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

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

Hiv Infection
538
Drug Use For Unknown Indication
50
Acquired Immunodeficiency Syndrome
43
Drug Exposure During Pregnancy
22
Retroviral Infection
10
Hiv Test Positive
9
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Antiretroviral Therapy
5
Drug Resistance
2
Hiv Infection Cdc Category C3
2
Urticaria
2
Multiple-drug Resistance
1
Viral Infection
1
Hiv Infection Cdc Category A3
1
Adverse Event
1
Systemic Antiviral Treatment
1
Prophylaxis Against Hiv Infection
1

Drug Labels

LabelLabelerEffective
AptivusBoehringer Ingelheim Pharmaceuticals, Inc.11-APR-12

Aptivus Case Reports

What Aptivus 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 Aptivus. 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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