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Intelence Adverse Events Reported to the FDA Over Time

How are Intelence adverse event reports trending over time?

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

Most Common Intelence Adverse Events Reported to the FDA

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

Rash
57 (2.46%)
Drug Exposure During Pregnancy
47 (2.03%)
Pyrexia
41 (1.77%)
Drug Interaction
33 (1.42%)
Fatigue
30 (1.29%)
Abortion Spontaneous
29 (1.25%)
Renal Failure Acute
26 (1.12%)
Lipodystrophy Acquired
21 (.91%)
Drug Rash With Eosinophilia And Sys...
20 (.86%)
Liver Disorder
20 (.86%)
Death
19 (.82%)
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Stevens-johnson Syndrome
19 (.82%)
Aspartate Aminotransferase Increase...
18 (.78%)
Hepatic Enzyme Increased
17 (.73%)
Diarrhoea
16 (.69%)
Exomphalos
16 (.69%)
Hepatic Failure
16 (.69%)
Neuropathy Peripheral
16 (.69%)
Abdominal Pain
15 (.65%)
Drug Ineffective
15 (.65%)
Headache
15 (.65%)
Hepatitis
15 (.65%)
Hypertension
15 (.65%)
Transaminases Increased
15 (.65%)
Weight Increased
15 (.65%)
Alanine Aminotransferase Increased
14 (.6%)
Dehydration
14 (.6%)
Nausea
14 (.6%)
Spastic Paraplegia
14 (.6%)
Spinal Cord Disorder
14 (.6%)
Subacute Combined Cord Degeneration
14 (.6%)
Vitamin B12 Deficiency
14 (.6%)
Arthralgia
13 (.56%)
Urticaria
13 (.56%)
Vomiting
13 (.56%)
Confusional State
12 (.52%)
Jaundice
12 (.52%)
Muscular Weakness
12 (.52%)
Premature Baby
12 (.52%)
Uveitis
12 (.52%)
Anaemia
11 (.47%)
Cachexia
11 (.47%)
Dyspnoea
11 (.47%)
Immune Reconstitution Syndrome
11 (.47%)
Lymphadenopathy
11 (.47%)
Off Label Use
11 (.47%)
Osteonecrosis
11 (.47%)
Rash Maculo-papular
11 (.47%)
Depression
10 (.43%)
Haemorrhagic Diathesis
10 (.43%)
Hepatic Steatosis
10 (.43%)
Oedema Peripheral
10 (.43%)
Rash Generalised
10 (.43%)
Sepsis
10 (.43%)
Thrombocytopenia
10 (.43%)
Ataxia
9 (.39%)
Diabetes Mellitus
9 (.39%)
Nephropathy
9 (.39%)
Paraesthesia
9 (.39%)
Pruritus
9 (.39%)
Blood Iron Decreased
8 (.34%)
Caudal Regression Syndrome
8 (.34%)
Choking
8 (.34%)
Cloacal Exstrophy
8 (.34%)
Condition Aggravated
8 (.34%)
Drug Eruption
8 (.34%)
Gastrointestinal Disorder Congenita...
8 (.34%)
Hypertriglyceridaemia
8 (.34%)
Hypokalaemia
8 (.34%)
Incorrect Dose Administered
8 (.34%)
Meconium Stain
8 (.34%)
Meningomyelocele
8 (.34%)
Multi-organ Failure
8 (.34%)
Pain In Extremity
8 (.34%)
Rhabdomyolysis
8 (.34%)
Umbilical Cord Abnormality
8 (.34%)
Anal Atresia
7 (.3%)
Asthenia
7 (.3%)
Bladder Agenesis
7 (.3%)
Congenital Genital Malformation
7 (.3%)
Convulsion
7 (.3%)
Face Oedema
7 (.3%)
Genitalia External Ambiguous
7 (.3%)
Haemorrhage
7 (.3%)
Hyperlipidaemia
7 (.3%)
Hypersensitivity
7 (.3%)
Malaise
7 (.3%)
Neutropenia
7 (.3%)
Oropharyngeal Swelling
7 (.3%)
Pollakiuria
7 (.3%)
Rash Pruritic
7 (.3%)
Syncope
7 (.3%)
Vertigo
7 (.3%)
Abortion Induced
6 (.26%)
Angioedema
6 (.26%)
Blood Alkaline Phosphatase Increase...
6 (.26%)
Blood Bilirubin Increased
6 (.26%)
Blood Cholesterol Increased
6 (.26%)
Blood Creatine Phosphokinase Increa...
6 (.26%)
Congenital Anomaly
6 (.26%)
Cytolytic Hepatitis
6 (.26%)

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

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

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

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

Hiv Infection
617
Product Used For Unknown Indication
37
Drug Use For Unknown Indication
34
Antiretroviral Therapy
19
Maternal Exposure Timing Unspecifie...
13
Antiviral Treatment
11
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Hiv Test Positive
9
Drug Exposure During Pregnancy
6
Acquired Immunodeficiency Syndrome
5
Foetal Exposure During Pregnancy
3
Acute Hiv Infection
2
Hiv Infection Cdc Group Iii
2
Hiv Infection Cdc Category A3
2
Antiviral Prophylaxis
1
Lentivirus Test Positive
1
Hiv Infection Cdc Category B2
1
Urticaria
1
Prophylaxis Against Hiv Infection
1

Drug Labels

LabelLabelerEffective
IntelenceState of Florida DOH Central Pharmacy06-AUG-10
IntelencePhysicians Total Care, Inc.02-JAN-13
IntelenceJanssen Products LP01-FEB-13
IntelenceREMEDYREPACK INC. 18-MAR-13

Intelence Case Reports

What Intelence 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 Intelence. 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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