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AMPHETAMINE SULFATE

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Amphetamine Sulfate Adverse Events Reported to the FDA Over Time

How are Amphetamine Sulfate adverse event reports trending over time?

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

Most Common Amphetamine Sulfate Adverse Events Reported to the FDA

What are the most common Amphetamine Sulfate adverse events reported to the FDA?

Drug Ineffective
250 (2.15%)
Product Substitution Issue
206 (1.77%)
Headache
189 (1.63%)
Insomnia
178 (1.53%)
Overdose
162 (1.39%)
Completed Suicide
160 (1.38%)
Aggression
156 (1.34%)
Anxiety
146 (1.26%)
Fatigue
132 (1.14%)
Depression
131 (1.13%)
Agitation
129 (1.11%)
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Abnormal Behaviour
122 (1.05%)
Suicidal Ideation
120 (1.03%)
Feeling Abnormal
118 (1.02%)
Nausea
105 (.9%)
Psychotic Disorder
104 (.9%)
Heart Rate Increased
98 (.84%)
Drug Effect Decreased
94 (.81%)
Irritability
94 (.81%)
Disturbance In Attention
90 (.77%)
Convulsion
88 (.76%)
Dizziness
87 (.75%)
Drug Interaction
85 (.73%)
Drug Abuse
82 (.71%)
Death
81 (.7%)
Palpitations
81 (.7%)
Somnolence
81 (.7%)
Chest Pain
80 (.69%)
Product Quality Issue
78 (.67%)
Weight Decreased
78 (.67%)
Cardiac Arrest
76 (.65%)
Tremor
76 (.65%)
Condition Aggravated
74 (.64%)
Dyspnoea
70 (.6%)
Drug Toxicity
66 (.57%)
Loss Of Consciousness
64 (.55%)
Drug Abuser
62 (.53%)
Respiratory Arrest
62 (.53%)
Blood Pressure Increased
61 (.53%)
Cardio-respiratory Arrest
61 (.53%)
Confusional State
59 (.51%)
Vomiting
59 (.51%)
Anger
58 (.5%)
Hallucination
58 (.5%)
Hyperhidrosis
56 (.48%)
Paranoia
55 (.47%)
Decreased Appetite
54 (.46%)
Malaise
54 (.46%)
Suicide Attempt
54 (.46%)
Fall
52 (.45%)
Tachycardia
52 (.45%)
Intentional Drug Misuse
50 (.43%)
Multiple Drug Overdose
48 (.41%)
Diarrhoea
47 (.4%)
Hypertension
47 (.4%)
Pyrexia
47 (.4%)
Attention Deficit/hyperactivity Dis...
45 (.39%)
Asthenia
44 (.38%)
Anorexia
43 (.37%)
Mania
40 (.34%)
Medication Error
40 (.34%)
Weight Increased
40 (.34%)
Drug Withdrawal Syndrome
39 (.34%)
Mood Swings
38 (.33%)
Drug Dependence
37 (.32%)
Drug Screen Positive
37 (.32%)
Tic
37 (.32%)
Abdominal Pain Upper
36 (.31%)
Crying
36 (.31%)
Pain
36 (.31%)
Cardiomegaly
35 (.3%)
Dyskinesia
35 (.3%)
Incorrect Dose Administered
35 (.3%)
Memory Impairment
34 (.29%)
Multiple Drug Overdose Intentional
34 (.29%)
Thinking Abnormal
34 (.29%)
Myocardial Infarction
33 (.28%)
Poisoning
33 (.28%)
Delusion
32 (.28%)
Hypoaesthesia
32 (.28%)
Off Label Use
31 (.27%)
Drug Dispensing Error
30 (.26%)
Grand Mal Convulsion
30 (.26%)
Restlessness
30 (.26%)
Rhabdomyolysis
30 (.26%)
Sudden Death
30 (.26%)
Blood Pressure Decreased
29 (.25%)
Intentional Overdose
29 (.25%)
Amnesia
28 (.24%)
Chest Discomfort
28 (.24%)
Cough
28 (.24%)
Drug Exposure During Pregnancy
28 (.24%)
Syncope
27 (.23%)
Coma
26 (.22%)
Lethargy
26 (.22%)
Abdominal Pain
25 (.22%)
Dry Mouth
25 (.22%)
Mood Altered
25 (.22%)
Paraesthesia
25 (.22%)
Therapeutic Response Unexpected Wit...
25 (.22%)
Dehydration
24 (.21%)

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

What are the most common Amphetamine Sulfate adverse events reported to the FDA?

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

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

Attention Deficit/hyperactivity Dis...
2007
Product Used For Unknown Indication
305
Drug Use For Unknown Indication
256
Fatigue
120
Depression
68
Narcolepsy
54
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Disturbance In Attention
45
Anxiety
32
Sleep Disorder
26
Drug Abuse
19
Bipolar Disorder
17
Suicide Attempt
17
Chronic Fatigue Syndrome
16
Psychomotor Hyperactivity
15
Asthenia
12
Somnolence
11
Memory Impairment
9
Sleep Apnoea Syndrome
9
Ill-defined Disorder
9
Mental Disorder
8
Oppositional Defiant Disorder
8
Multiple Sclerosis
8
Obsessive-compulsive Disorder
7
Hypersomnia
7
Drug Abuser
6
Hypertension
6
Energy Increased
6
Prophylaxis
5
Post-traumatic Stress Disorder
5
Autism
5
Drug Withdrawal Syndrome
4
Major Depression
4
Nervous System Disorder
4
Central Nervous System Stimulation
4
Autism Spectrum Disorder
4
Completed Suicide
4
Back Pain
3
Thinking Abnormal
3
Appetite Disorder
3
Abnormal Behaviour
3
Intervertebral Disc Protrusion
3
Withdrawal Syndrome
3
Cerebral Palsy
3
Fibromyalgia
3
Head Injury
3
Sluggishness
2
Drug Interaction
2
Hypervigilance
2
Dementia
2
Drug Exposure During Pregnancy
2
Sedation
2

Drug Labels

LabelLabelerEffective
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine SulfatePhysicians Total Care, Inc.18-MAY-10
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine SulfatePhysicians Total Care, Inc.18-MAY-10
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Suflate STAT RX USA LLC25-JUN-10
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine SulfateCorepharma LLC.02-AUG-11
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine SulfateEon Labs, Inc.27-SEP-11
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine SulfateActavis Elizabeth LLC10-FEB-12
AdderallxrPhysicians Total Care, Inc.25-SEP-12
AdderallBryant Ranch Prepack23-OCT-12
AdderallBryant Ranch Prepack23-OCT-12
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine SulfateBryant Ranch Prepack23-OCT-12
AdderallBarr Laboratories Inc.27-NOV-12
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine SulfateBarr Laboratories Inc.11-JAN-13
AdderallxrShire US Manufacturing Inc.11-JAN-13
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine SulfateGlobal Pharmaceuticals, Division of Impax Laboratories Inc.14-JAN-13
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine SulfateCorePharma, LLC01-FEB-13
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine SulfateBarr Laboratories Inc.28-MAR-13

Amphetamine Sulfate Case Reports

What Amphetamine Sulfate 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 Amphetamine Sulfate. 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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