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Heroin Adverse Events Reported to the FDA Over Time

How are Heroin adverse event reports trending over time?

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

Most Common Heroin Adverse Events Reported to the FDA

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

Drug Abuse
125 (4.13%)
Substance Abuse
119 (3.93%)
Overdose
108 (3.56%)
Respiratory Arrest
107 (3.53%)
Cardiac Arrest
103 (3.4%)
Drug Abuser
72 (2.38%)
Death
67 (2.21%)
Cardio-respiratory Arrest
63 (2.08%)
Drug Dependence
59 (1.95%)
Multiple Drug Overdose
54 (1.78%)
Intentional Drug Misuse
50 (1.65%)
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Drug Toxicity
48 (1.58%)
Drug Withdrawal Syndrome Neonatal
46 (1.52%)
Completed Suicide
38 (1.25%)
Drug Exposure During Pregnancy
38 (1.25%)
Narcotic Intoxication
30 (.99%)
Nystagmus
30 (.99%)
Poisoning
30 (.99%)
Developmental Delay
29 (.96%)
Pulmonary Oedema
29 (.96%)
Drug Withdrawal Syndrome
26 (.86%)
Coma
23 (.76%)
Unresponsive To Stimuli
21 (.69%)
Accidental Overdose
20 (.66%)
Loss Of Consciousness
20 (.66%)
Multiple Drug Overdose Intentional
20 (.66%)
Strabismus
19 (.63%)
Epilepsy
18 (.59%)
Polysubstance Dependence
18 (.59%)
Circulatory Collapse
17 (.56%)
Intentional Overdose
17 (.56%)
Somnolence
17 (.56%)
Suicide Attempt
17 (.56%)
Vomiting
16 (.53%)
Congenital Nystagmus
14 (.46%)
Drug Screen Positive
14 (.46%)
Euphoric Mood
14 (.46%)
Pain
14 (.46%)
Electrocardiogram St Segment Abnorm...
13 (.43%)
Fall
13 (.43%)
Depression
12 (.4%)
Alanine Aminotransferase Increased
11 (.36%)
Aspartate Aminotransferase Increase...
11 (.36%)
Drug Diversion
11 (.36%)
Drug Interaction
11 (.36%)
Electrocardiogram Qt Prolonged
11 (.36%)
Suicidal Ideation
11 (.36%)
Tremor
11 (.36%)
Aggression
10 (.33%)
Agitation
10 (.33%)
Hypokalaemia
10 (.33%)
Incorrect Route Of Drug Administrat...
10 (.33%)
Mental Status Changes
10 (.33%)
Aspiration
9 (.3%)
Cardiac Failure
9 (.3%)
Convulsion
9 (.3%)
Depressed Level Of Consciousness
9 (.3%)
Immune System Disorder
9 (.3%)
Malaise
9 (.3%)
Multiple Drug Overdose Accidental
9 (.3%)
Premature Baby
9 (.3%)
Rhabdomyolysis
9 (.3%)
Abnormal Behaviour
8 (.26%)
Accidental Death
8 (.26%)
Cardiomegaly
8 (.26%)
Congenital Visual Acuity Reduced
8 (.26%)
Diarrhoea
8 (.26%)
Insomnia
8 (.26%)
Off Label Use
8 (.26%)
Pulmonary Congestion
8 (.26%)
Visual Impairment
8 (.26%)
Withdrawal Syndrome
8 (.26%)
Anxiety
7 (.23%)
Astigmatism
7 (.23%)
Caesarean Section
7 (.23%)
Cyanosis
7 (.23%)
Failure To Thrive
7 (.23%)
Hypotension
7 (.23%)
Irritability
7 (.23%)
Liver Function Test Abnormal
7 (.23%)
Nausea
7 (.23%)
Renal Failure Acute
7 (.23%)
Syncope
7 (.23%)
Accidental Exposure
6 (.2%)
Acute Respiratory Distress Syndrome
6 (.2%)
Adverse Event
6 (.2%)
Blood Creatine Phosphokinase Increa...
6 (.2%)
Crying
6 (.2%)
Hyperhidrosis
6 (.2%)
Injury
6 (.2%)
Left Ventricular Dysfunction
6 (.2%)
Maternal Drugs Affecting Foetus
6 (.2%)
Muscle Spasms
6 (.2%)
Sedation
6 (.2%)
Tachycardia
6 (.2%)
Cerebral Haemorrhage
5 (.17%)
Fatigue
5 (.17%)
Gait Disturbance
5 (.17%)
Gamma-glutamyltransferase Increased
5 (.17%)
Hepatitis C
5 (.17%)
Hypertension
5 (.17%)

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

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

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

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

Drug Use For Unknown Indication
174
Product Used For Unknown Indication
158
Drug Abuse
119
Drug Abuser
43
Drug Dependence
18
Ill-defined Disorder
15
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Overdose
15
Drug Exposure During Pregnancy
13
Substance Abuse
12
Foetal Exposure During Pregnancy
11
Intentional Drug Misuse
10
Substance Use
4
Drug Withdrawal Syndrome
3
Intentional Overdose
3
Withdrawal Syndrome
3
Drug Diversion
2
Intentional Misuse
2
Asthenia
1
Poisoning Deliberate
1
Accidental Exposure
1
Dependence
1
Completed Suicide
1

Heroin Case Reports

What Heroin 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 Heroin. 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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