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SEROQUEL XR

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Seroquel Xr Adverse Events Reported to the FDA Over Time

How are Seroquel Xr adverse event reports trending over time?

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

Most Common Seroquel Xr Adverse Events Reported to the FDA

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

Drug Dose Omission
2087 (6.65%)
Insomnia
1320 (4.2%)
Off Label Use
718 (2.29%)
Malaise
603 (1.92%)
Somnolence
571 (1.82%)
Weight Increased
533 (1.7%)
Depression
494 (1.57%)
Feeling Abnormal
493 (1.57%)
Anxiety
454 (1.45%)
Drug Ineffective
348 (1.11%)
Intentional Drug Misuse
345 (1.1%)
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Fatigue
313 (1%)
Headache
312 (.99%)
Nausea
298 (.95%)
Dizziness
285 (.91%)
Suicidal Ideation
267 (.85%)
Wrong Technique In Drug Usage Proce...
256 (.82%)
Vomiting
244 (.78%)
Tremor
243 (.77%)
Fall
237 (.75%)
Adverse Event
227 (.72%)
Convulsion
226 (.72%)
Agitation
222 (.71%)
Bipolar Disorder
222 (.71%)
Confusional State
219 (.7%)
Incorrect Dose Administered
197 (.63%)
Therapeutic Response Unexpected
196 (.62%)
Memory Impairment
186 (.59%)
Suicide Attempt
175 (.56%)
Hypersomnia
174 (.55%)
Drug Withdrawal Syndrome
173 (.55%)
Nervousness
169 (.54%)
Panic Attack
164 (.52%)
Diarrhoea
163 (.52%)
Amnesia
162 (.52%)
Mental Disorder
161 (.51%)
Mania
156 (.5%)
Irritability
153 (.49%)
Aggression
151 (.48%)
Dry Mouth
146 (.47%)
Overdose
145 (.46%)
Pain
145 (.46%)
Dyspnoea
130 (.41%)
Hyperhidrosis
130 (.41%)
Weight Decreased
130 (.41%)
Psychotic Disorder
129 (.41%)
Crying
128 (.41%)
Road Traffic Accident
123 (.39%)
Loss Of Consciousness
122 (.39%)
Activities Of Daily Living Impaired
121 (.39%)
Hallucination
121 (.39%)
Death
120 (.38%)
Sedation
119 (.38%)
Asthenia
116 (.37%)
Hypertension
111 (.35%)
Mood Swings
109 (.35%)
Withdrawal Syndrome
108 (.34%)
Sleep Disorder
105 (.33%)
Nasopharyngitis
104 (.33%)
Anger
103 (.33%)
Drug Prescribing Error
103 (.33%)
Disturbance In Attention
101 (.32%)
Abnormal Behaviour
99 (.32%)
Constipation
98 (.31%)
Dyskinesia
98 (.31%)
Tachyphrenia
98 (.31%)
Pneumonia
97 (.31%)
Disorientation
96 (.31%)
Myalgia
95 (.3%)
Hallucination, Auditory
94 (.3%)
Gait Disturbance
92 (.29%)
Leukopenia
92 (.29%)
Diabetes Mellitus
89 (.28%)
Abdominal Discomfort
88 (.28%)
Nightmare
88 (.28%)
Impaired Work Ability
84 (.27%)
Stress
84 (.27%)
Cerebrovascular Accident
83 (.26%)
Pain In Extremity
83 (.26%)
Abdominal Pain Upper
82 (.26%)
Dysphagia
82 (.26%)
Drug Intolerance
80 (.25%)
Lethargy
79 (.25%)
Mental Impairment
79 (.25%)
Neutropenia
78 (.25%)
Palpitations
78 (.25%)
Chest Pain
77 (.25%)
Muscle Spasms
77 (.25%)
Thinking Abnormal
77 (.25%)
Restlessness
76 (.24%)
Oedema Peripheral
75 (.24%)
Adverse Drug Reaction
74 (.24%)
Paranoia
74 (.24%)
Arthralgia
73 (.23%)
Condition Aggravated
73 (.23%)
Depressed Mood
73 (.23%)
Migraine
72 (.23%)
Tardive Dyskinesia
72 (.23%)
Visual Impairment
72 (.23%)
Blood Cholesterol Increased
71 (.23%)
Schizophrenia
71 (.23%)

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

What are the most common Seroquel Xr 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 Xr, 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 Xr 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 Xr According to Those Reporting Adverse Events

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

Bipolar Disorder
1483
Depression
782
Sleep Disorder
380
Bipolar I Disorder
304
Anxiety
297
Schizophrenia
289
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Major Depression
196
Insomnia
152
Psychotic Disorder
145
Post-traumatic Stress Disorder
94
Affective Disorder
88
Mania
77
Schizoaffective Disorder
74
Bipolar Ii Disorder
46
Mood Swings
46
Schizophrenia, Paranoid Type
44
Mental Disorder
42
Panic Attack
38
Product Used For Unknown Indication
32
Nervousness
28
Obsessive-compulsive Disorder
27
Attention Deficit/hyperactivity Dis...
24
Dementia
24
Paranoia
23
Borderline Personality Disorder
22
Anxiety Disorder
21
Suicidal Ideation
19
Hallucination
19
Hallucination, Auditory
18
Personality Disorder
16
Generalised Anxiety Disorder
16
Anger
15
Panic Disorder
14
Dementia Alzheimers Type
14
Mood Altered
14
Tachyphrenia
14
Agitation
13
Restlessness
10
Autism
10
Stress
9
Nightmare
9
Convulsion
8
Aspergers Disorder
8
Aggression
8
Suicide Attempt
7
Abnormal Behaviour
7
Somnolence
7
Drug Use For Unknown Indication
7
Delusional Disorder, Unspecified Ty...
6
Sleep Disorder Therapy
6
Oppositional Defiant Disorder
6

Drug Labels

LabelLabelerEffective
SeroquelxrAstraZeneca Pharmaceuticals LP09-NOV-11
SeroquelxrPhysicians Total Care, Inc.06-FEB-12

Seroquel Xr Case Reports

What Seroquel Xr 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 Xr. 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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