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Isentress Adverse Events Reported to the FDA Over Time

How are Isentress adverse event reports trending over time?

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

Most Common Isentress Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
421 (2.67%)
Rash
186 (1.18%)
Diarrhoea
178 (1.13%)
Pyrexia
173 (1.1%)
Immune Reconstitution Syndrome
149 (.94%)
Lipodystrophy Acquired
136 (.86%)
Thrombocytopenia
132 (.84%)
Renal Failure Acute
127 (.8%)
Nausea
121 (.77%)
Depression
118 (.75%)
Headache
115 (.73%)
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Death
110 (.7%)
Alanine Aminotransferase Increased
109 (.69%)
Anaemia
105 (.67%)
Premature Baby
101 (.64%)
Pneumonia
98 (.62%)
Aspartate Aminotransferase Increase...
96 (.61%)
Cytolytic Hepatitis
90 (.57%)
Abortion Spontaneous
87 (.55%)
Arthralgia
85 (.54%)
Blood Creatine Phosphokinase Increa...
83 (.53%)
Sepsis
83 (.53%)
Exomphalos
81 (.51%)
Fatigue
81 (.51%)
Vomiting
81 (.51%)
Drug Rash With Eosinophilia And Sys...
79 (.5%)
Liver Function Test Abnormal
77 (.49%)
Neutropenia
76 (.48%)
Weight Decreased
76 (.48%)
Stevens-johnson Syndrome
75 (.48%)
Cardiac Murmur
73 (.46%)
Sudden Infant Death Syndrome
73 (.46%)
Bladder Agenesis
72 (.46%)
Lymphadenopathy
71 (.45%)
Dizziness
69 (.44%)
Ventricular Hypertrophy
69 (.44%)
Asthenia
68 (.43%)
Hypertension
67 (.42%)
Maternal Drugs Affecting Foetus
66 (.42%)
Cholestasis
65 (.41%)
Pancreatitis
65 (.41%)
Renal Failure
65 (.41%)
Congenital Heart Valve Disorder
64 (.41%)
Drug Interaction
64 (.41%)
Hepatic Failure
63 (.4%)
Pancytopenia
63 (.4%)
Myalgia
62 (.39%)
Dyspnoea
61 (.39%)
Hyperlipidaemia
61 (.39%)
Neuropathy Peripheral
61 (.39%)
Congenital Genital Malformation
60 (.38%)
Drug Toxicity
60 (.38%)
Anal Atresia
59 (.37%)
Eosinophilia
59 (.37%)
Insomnia
59 (.37%)
Renal Impairment
59 (.37%)
Pain In Extremity
58 (.37%)
Pruritus
58 (.37%)
Rhabdomyolysis
57 (.36%)
Dehydration
56 (.35%)
Mitochondrial Toxicity
55 (.35%)
Rash Maculo-papular
55 (.35%)
Diplopia
54 (.34%)
Eyelid Ptosis
54 (.34%)
Progressive External Ophthalmoplegi...
54 (.34%)
Hepatitis
53 (.34%)
Anxiety
51 (.32%)
Cloacal Exstrophy
51 (.32%)
Oedema Peripheral
51 (.32%)
Rash Generalised
51 (.32%)
Abdominal Pain
50 (.32%)
Adverse Event
50 (.32%)
Caudal Regression Syndrome
50 (.32%)
Congenital Anomaly
50 (.32%)
Meningomyelocele
50 (.32%)
Apnoea
48 (.3%)
Hypersensitivity
48 (.3%)
Jaundice
48 (.3%)
Paraesthesia
48 (.3%)
Suicidal Ideation
48 (.3%)
Myopathy
46 (.29%)
Diabetes Mellitus
45 (.29%)
Umbilical Cord Abnormality
45 (.29%)
Hepatic Encephalopathy
44 (.28%)
Premature Labour
44 (.28%)
Small For Dates Baby
44 (.28%)
Blood Iron Decreased
43 (.27%)
Metabolic Acidosis
43 (.27%)
Oesophageal Candidiasis
43 (.27%)
Blood Creatinine Increased
42 (.27%)
Osteonecrosis
42 (.27%)
Weight Increased
42 (.27%)
Cachexia
41 (.26%)
Hepatic Enzyme Increased
41 (.26%)
Meconium Stain
41 (.26%)
Acute Hepatic Failure
40 (.25%)
Genitalia External Ambiguous
40 (.25%)
Pain
40 (.25%)
Viral Load Increased
40 (.25%)
Convulsion
39 (.25%)
Gamma-glutamyltransferase Increased
39 (.25%)

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

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

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

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

Hiv Infection
3936
Product Used For Unknown Indication
144
Drug Exposure During Pregnancy
130
Antiretroviral Therapy
115
Drug Use For Unknown Indication
93
Acquired Immunodeficiency Syndrome
84
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Hiv Test Positive
64
Antiviral Treatment
47
Maternal Exposure Timing Unspecifie...
14
Prophylaxis Against Transplant Reje...
14
Prophylaxis Against Hiv Infection
11
Hiv Test
7
Maternal Exposure During Pregnancy
6
Foetal Exposure During Pregnancy
5
Immunodeficiency
4
Pathogen Resistance
3
Salvage Therapy
3
Hiv Infection Cdc Category C3
3
Acute Hiv Infection
3
Multiple-drug Resistance
3
Hepatitis B
2
Prophylaxis
2
Urticaria
2
Metabolic Disorder
2
Kaposis Sarcoma Aids Related
2
Cd4 Lymphocytes Decreased
2
Exposure To Communicable Disease
2
Hiv Infection Cdc Group Iii
2
Blood Hiv Rna
1
Hiv Infection Cdc Category A2
1
Virologic Failure
1
Persistent Generalised Lymphadenopa...
1
Cachexia
1
Cd4 Lymphocytes Increased
1
Neoplasm Malignant
1
Anti-infective Therapy
1
Hiv Antibody Positive
1
Drug Hypersensitivity
1
Pain
1
Oesophagitis
1
Hepatitis C
1
Hiv Infection Cdc Category A1
1
Papilloma Viral Infection
1
Suicide Attempt
1
Human Immunodeficiency Virus Transm...
1
T-lymphocyte Count Increased
1
Pregnancy
1
Hiv Antigen Positive
1

Drug Labels

LabelLabelerEffective
IsentressState of Florida DOH Central Pharmacy11-AUG-10
IsentressPhysicians Total Care, Inc.07-FEB-12
IsentressMerck Sharp & Dohme Corp.04-APR-13
IsentressREMEDYREPACK INC. 10-APR-13
IsentressREMEDYREPACK INC. 10-APR-13

Isentress Case Reports

What Isentress 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 Isentress. 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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