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Seroquel Adverse Events Reported to the FDA Over Time

How are Seroquel adverse event reports trending over time?

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

Most Common Seroquel Adverse Events Reported to the FDA

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

Diabetes Mellitus
10276 (4.35%)
Drug Dose Omission
7714 (3.27%)
Insomnia
6095 (2.58%)
Type 2 Diabetes Mellitus
4913 (2.08%)
Pancreatitis
4431 (1.88%)
Weight Increased
3735 (1.58%)
Off Label Use
3144 (1.33%)
Somnolence
2816 (1.19%)
Malaise
2451 (1.04%)
Depression
2410 (1.02%)
Anxiety
2231 (.94%)
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Feeling Abnormal
2126 (.9%)
Death
1991 (.84%)
Blood Cholesterol Increased
1950 (.83%)
Suicidal Ideation
1811 (.77%)
Ill-defined Disorder
1678 (.71%)
Diabetic Ketoacidosis
1665 (.7%)
Fatigue
1652 (.7%)
Dizziness
1636 (.69%)
Drug Ineffective
1605 (.68%)
Ketoacidosis
1589 (.67%)
Headache
1579 (.67%)
Fall
1496 (.63%)
Convulsion
1495 (.63%)
Suicide Attempt
1461 (.62%)
Obesity
1452 (.61%)
Intentional Drug Misuse
1435 (.61%)
Hyperglycaemia
1433 (.61%)
Overdose
1426 (.6%)
Nausea
1413 (.6%)
Tremor
1346 (.57%)
Agitation
1306 (.55%)
Vomiting
1288 (.55%)
Diabetic Coma
1194 (.51%)
Tardive Dyskinesia
1119 (.47%)
Completed Suicide
1117 (.47%)
Diabetes Mellitus Inadequate Contro...
1107 (.47%)
Hypertension
1070 (.45%)
Incorrect Dose Administered
1036 (.44%)
Bipolar Disorder
1028 (.44%)
Confusional State
1015 (.43%)
Hyperlipidaemia
999 (.42%)
Neuropathy Peripheral
979 (.41%)
Wrong Technique In Drug Usage Proce...
958 (.41%)
Diabetic Neuropathy
955 (.4%)
Loss Of Consciousness
952 (.4%)
Blood Triglycerides Increased
918 (.39%)
Aggression
895 (.38%)
Weight Decreased
865 (.37%)
Dyspnoea
856 (.36%)
Pain
846 (.36%)
Type 1 Diabetes Mellitus
834 (.35%)
Mania
819 (.35%)
Mental Disorder
804 (.34%)
Hallucination
802 (.34%)
Adverse Event
790 (.33%)
Therapeutic Response Unexpected
787 (.33%)
Drug Interaction
781 (.33%)
Memory Impairment
775 (.33%)
Neuroleptic Malignant Syndrome
770 (.33%)
Diarrhoea
763 (.32%)
Pneumonia
763 (.32%)
Drug Withdrawal Syndrome
760 (.32%)
Irritability
748 (.32%)
Panic Attack
748 (.32%)
Blood Glucose Increased
720 (.3%)
Dry Mouth
716 (.3%)
Asthenia
713 (.3%)
Constipation
707 (.3%)
Chest Pain
704 (.3%)
Amnesia
702 (.3%)
Nervousness
696 (.29%)
Road Traffic Accident
679 (.29%)
Psychotic Disorder
671 (.28%)
Back Pain
668 (.28%)
Hyperhidrosis
638 (.27%)
Dyskinesia
637 (.27%)
Sleep Disorder
627 (.27%)
Hypotension
625 (.26%)
Abnormal Behaviour
618 (.26%)
Vision Blurred
618 (.26%)
Crying
609 (.26%)
Sedation
587 (.25%)
Tachycardia
584 (.25%)
Pain In Extremity
582 (.25%)
Cerebrovascular Accident
574 (.24%)
Hypersomnia
568 (.24%)
Pancreatitis Acute
568 (.24%)
Anger
560 (.24%)
Intentional Overdose
553 (.23%)
Mood Swings
552 (.23%)
Neutropenia
550 (.23%)
Coma
546 (.23%)
Nightmare
544 (.23%)
Gait Disturbance
543 (.23%)
Myocardial Infarction
543 (.23%)
Leukopenia
531 (.22%)
Pyrexia
530 (.22%)
Restlessness
525 (.22%)
Muscle Spasms
510 (.22%)
Dysphagia
507 (.21%)

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

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

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

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

Bipolar Disorder
10583
Depression
8852
Sleep Disorder
4275
Schizophrenia
4118
Anxiety
3421
Insomnia
2546
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Bipolar I Disorder
1511
Psychotic Disorder
1467
Drug Use For Unknown Indication
1316
Post-traumatic Stress Disorder
863
Product Used For Unknown Indication
779
Schizoaffective Disorder
738
Affective Disorder
718
Major Depression
681
Mental Disorder
636
Agitation
465
Mania
384
Schizophrenia, Paranoid Type
363
Hallucination
349
Dementia
329
Mood Swings
275
Hallucination, Auditory
253
Obsessive-compulsive Disorder
224
Bipolar Ii Disorder
221
Panic Attack
216
Dementia Alzheimers Type
216
Paranoia
214
Attention Deficit/hyperactivity Dis...
203
Nervousness
174
Abnormal Behaviour
168
Restlessness
164
Aggression
144
Anxiety Disorder
134
Ill-defined Disorder
132
Borderline Personality Disorder
127
Personality Disorder
116
Sleep Disorder Therapy
115
Panic Disorder
111
Delirium
111
Delusion
108
Nightmare
88
Stress
87
Tachyphrenia
84
Anger
83
Suicidal Ideation
78
Mood Altered
74
Somnolence
70
Convulsion
70
Generalised Anxiety Disorder
68
Thinking Abnormal
62
Autism
56

Drug Labels

LabelLabelerEffective
SeroquelContract Pharmacy Services-PA01-JUN-10
SeroquelLake Erie Medical DBA Quality Care Products LLC07-JUL-10
SeroquelLake Erie Medical DBA Quality Care Products LLC08-JUL-10
SeroquelRebel Distributors Corp27-DEC-10
Seroquel REMEDYREPACK INC. 23-MAR-11
SeroquelSTAT RX USA LLC07-JUL-11
SeroquelPD-Rx Pharmaceuticals, Inc.13-JUL-11
SeroquelCardinal Health13-OCT-11
SeroquelxrAstraZeneca Pharmaceuticals LP09-NOV-11
SeroquelAstraZeneca Pharmaceuticals LP09-NOV-11
SeroquelPD-Rx Pharmaceuticals, Inc.09-NOV-11
SeroquelPD-Rx Pharmaceuticals, Inc.09-NOV-11
SeroquelxrPhysicians Total Care, Inc.06-FEB-12
SeroquelPhysicians Total Care, Inc.06-FEB-12
SeroquelLake Erie Medical & Surgical Supply DBA Quality Care Products LLC18-APR-12
SeroquelLake Erie Medical & Surgical Supply DBA Quality Care Products LLC18-APR-12
SeroquelBryant Ranch Prepack24-OCT-12
SeroquelBryant Ranch Prepack24-OCT-12
SeroquelBryant Ranch Prepack24-OCT-12
SeroquelBryant Ranch Prepack24-OCT-12
SeroquelBryant Ranch Prepack13-FEB-13
SeroquelREMEDYREPACK INC. 10-APR-13
SeroquelREMEDYREPACK INC. 10-APR-13
SeroquelREMEDYREPACK INC. 10-APR-13
SeroquelREMEDYREPACK INC. 10-APR-13
SeroquelREMEDYREPACK INC. 10-APR-13
SeroquelREMEDYREPACK INC. 24-APR-13
SeroquelCardinal Health02-MAY-13

Seroquel Case Reports

What Seroquel 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 Seroquel. 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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