Common Seroquel Side Effects


The most commonly reported Seroquel side effects (click to view or check a box to report):

Diabetes Mellitus (6047)
Type 2 Diabetes Mellitus (3522)
Insomnia (2188)
Pancreatitis (1888)
Blood Cholesterol Increased (1680)
Weight Increased (1642)
Obesity (1149)
Diabetes Mellitus Inadequate Control (1044)
Diabetic Ketoacidosis (1037)
Depression (1013)
Hyperglycaemia (989)
Diabetic Neuropathy (958)
Somnolence (948)
Anxiety (946)
Malaise (923)
Off Label Use (900)
Feeling Abnormal (781)
Blood Triglycerides Increased (777)
Diabetic Coma (758)
Suicidal Ideation (757)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Seroquel Side Effects Reported to FDA



Seroquel Side Effect Report#9995024
Loss Of Consciousness
This is a report of a 38-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: sleep disorder, who was treated with Seroquel (dosage: Administered Pills - At Pysh. Hospital/samples; Bedtime As Needed/required, start time: 201303), combined with: NA. and developed a serious reaction and side effect(s): Loss Of Consciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Seroquel treatment in female patients, resulting in Loss Of Consciousness side effect.
Seroquel Side Effect Report#9988027
Off Label Use
This report suggests a potential Seroquel Xr Death side effect(s) that can have serious consequences. A 85-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dementia and used Seroquel Xr (dosage: NA) starting NS. After starting Seroquel Xr the patient began experiencing various side effects, including: Off Label UseAdditional drugs used concurrently: NA. Although Seroquel Xr demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Seroquel Side Effect Report#9988016
Overdose, Suicidal Behaviour, Vomiting
This Overdose problem was reported by a physician from US. A 33-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Seroquel (dosage: 15 Tablets Once). The following drugs were being taken at the same time:
  • Fetzima
  • Fetzima
  • Hydrocodone (30 Tablets Once)
  • Celexa
  • Risperdal
  • Lamictal
When using Seroquel, the patient experienced the following unwanted symptoms/side effects: Overdose, Suicidal Behaviour, VomitingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Overdose, may become evident only after a product is in use by the general population.
Seroquel Side Effect Report#9987912
Intestinal Obstruction
This Intestinal Obstruction side effect was reported by a pharmacist from US. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Seroquel (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Seroquel the consumer reported adverse symptoms, such as: Intestinal ObstructionThese side effects may potentially be related to Seroquel.
Seroquel Side Effect Report#9985971
Renal Impairment, Blood Creatinine Increased, Blood Urea Increased, Glomerular Filtration Rate Decreased, Glomerular Filtration Rate Increased
This is a report of a 51-year-old female patient (weight: NA) from IE, suffering from the following health symptoms/conditions: anxiety disorder,affective disorder,depression, who was treated with Seroquel Ir (dosage: NA, start time:
Sep 03, 2013), combined with: NA. and developed a serious reaction and side effect(s): Renal Impairment, Blood Creatinine Increased, Blood Urea Increased, Glomerular Filtration Rate Decreased, Glomerular Filtration Rate Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Seroquel Ir treatment in female patients, resulting in Renal Impairment side effect.
Seroquel Side Effect Report#9985635
Neoplasm Malignant
This report suggests a potential Seroquel Xr Neoplasm Malignant side effect(s) that can have serious consequences. A 86-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Seroquel Xr (dosage: NA) starting NS. After starting Seroquel Xr the patient began experiencing various side effects, including: Neoplasm MalignantAdditional drugs used concurrently: NA. Although Seroquel Xr demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neoplasm Malignant, may still occur.
Seroquel Side Effect Report#9973673
Spasmodic Dysphonia
This Spasmodic Dysphonia problem was reported by a physician from AU. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: bipolar disorder. On 2003 this consumer started treatment with Seroquel (dosage: NA). The following drugs were being taken at the same time: NA. When using Seroquel, the patient experienced the following unwanted symptoms/side effects: Spasmodic DysphoniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Spasmodic Dysphonia, may become evident only after a product is in use by the general population.
Seroquel Side Effect Report#9971431
Amnesia, Personality Change, Memory Impairment
This Amnesia side effect was reported by a consumer or non-health professional from US. A 21-year-old female patient (weight:NA) experienced the following symptoms/conditions: bipolar disorder.The patient was prescribed Seroquel Seroquel (drug dosage: 1 Pill Once Daily), which was initiated on NS. Concurrently used drugs:
  • Abilify Abilify (1 Pill Once Daily)
.After starting to take Seroquel Seroquel the consumer reported adverse symptoms, such as: Amnesia, Personality Change, Memory ImpairmentThese side effects may potentially be related to Seroquel Seroquel. The patient was hospitalized and became disabled.
Seroquel Side Effect Report#9967008
Cerebral Infarction, Insomnia, Off Label Use
This is a report of a 60-year-old female patient (weight: NA) from CN, suffering from the following health symptoms/conditions: insomnia, who was treated with Seroquel (dosage: NA, start time: 2013), combined with: NA. and developed a serious reaction and side effect(s): Cerebral Infarction, Insomnia, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Seroquel treatment in female patients, resulting in Cerebral Infarction side effect.
Seroquel Side Effect Report#9963903
Suicidal Ideation, Self Injurious Behaviour, Alopecia, Dependence, Depression, Hair Growth Abnormal, Loss Of Libido, Mood Swings, Nervousness
This report suggests a potential Seroquel Suicidal Ideation side effect(s) that can have serious consequences. A 24-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: panic attack,contraception,attention deficit/hyperactivity disorder and used Seroquel (dosage: NA) starting 2008. After starting Seroquel the patient began experiencing various side effects, including: Suicidal Ideation, Self Injurious Behaviour, Alopecia, Dependence, Depression, Hair Growth Abnormal, Loss Of Libido, Mood Swings, NervousnessAdditional drugs used concurrently:
  • Mirena
  • Strattera
  • Ritalin
  • Aponal
  • Omeprazol
The patient was hospitalized. Although Seroquel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicidal Ideation, may still occur.
Seroquel Side Effect Report#9955066
Loss Of Consciousness, Feeling Abnormal, Sedation, Tremor
This Loss Of Consciousness problem was reported by a physician from US. A 19-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: bipolar disorder. On
Feb 14, 2014 this consumer started treatment with Seroquel (dosage: NA). The following drugs were being taken at the same time: NA. When using Seroquel, the patient experienced the following unwanted symptoms/side effects: Loss Of Consciousness, Feeling Abnormal, Sedation, TremorAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Loss Of Consciousness, may become evident only after a product is in use by the general population.
Seroquel Side Effect Report#9942348
Pancytopenia
This Pancytopenia side effect was reported by a pharmacist from JP. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: schizophrenia.The patient was prescribed Seroquel (drug dosage: NA), which was initiated on
Feb 22, 2014. Concurrently used drugs: NA..After starting to take Seroquel the consumer reported adverse symptoms, such as: PancytopeniaThese side effects may potentially be related to Seroquel.
Seroquel Side Effect Report#9934314
Feeling Abnormal, Derealisation, Neuropathy Peripheral, Malaise, Nightmare
This is a report of a 40-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: bipolar disorder, who was treated with Seroquel (dosage: NA, start time: 2010), combined with: NA. and developed a serious reaction and side effect(s): Feeling Abnormal, Derealisation, Neuropathy Peripheral, Malaise, Nightmare after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Seroquel treatment in female patients, resulting in Death side effect.
Seroquel Side Effect Report#9931529
Road Traffic Accident, Sedation
This report suggests a potential Seroquel Xr Road Traffic Accident side effect(s) that can have serious consequences. A 40-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: bipolar i disorder and used Seroquel Xr (dosage: NA) starting NS. After starting Seroquel Xr the patient began experiencing various side effects, including: Road Traffic Accident, SedationAdditional drugs used concurrently: NA. Although Seroquel Xr demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Road Traffic Accident, may still occur.
Seroquel Side Effect Report#9931528
Road Traffic Accident, Sedation
This Road Traffic Accident problem was reported by a physician from US. A 40-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bipolar i disorder. On NS this consumer started treatment with Seroquel Xr (dosage: NA). The following drugs were being taken at the same time: NA. When using Seroquel Xr, the patient experienced the following unwanted symptoms/side effects: Road Traffic Accident, SedationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Road Traffic Accident, may become evident only after a product is in use by the general population.
Seroquel Side Effect Report#9931121
Intentional Overdose, Toxicity To Various Agents, Off Label Use
This Intentional Overdose side effect was reported by a health professional from JP. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: depressive symptom.The patient was prescribed Seroquel (drug dosage: NA), which was initiated on
Mar 30, 2013. Concurrently used drugs: NA..After starting to take Seroquel the consumer reported adverse symptoms, such as: Intentional Overdose, Toxicity To Various Agents, Off Label UseThese side effects may potentially be related to Seroquel. The patient was hospitalized.
Seroquel Side Effect Report#9931021
Diabetes Mellitus, Glycosylated Haemoglobin Increased, Hyperglycaemia
This is a report of a 41-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: schizophrenia, who was treated with Seroquel (dosage: NA, start time: 201304), combined with:
  • Zyprexa
and developed a serious reaction and side effect(s): Diabetes Mellitus, Glycosylated Haemoglobin Increased, Hyperglycaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Seroquel treatment in male patients, resulting in Diabetes Mellitus side effect. The patient was hospitalized.
Seroquel Side Effect Report#9926384
Learning Disability, Hearing Impaired, Elevated Mood, Eating Disorder, Attention Deficit/hyperactivity Disorder, Epilepsy
This report suggests a potential Seroquel Xr Learning Disability side effect(s) that can have serious consequences. A 4-year-old female patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: schizophrenia and used Seroquel Xr (dosage: NA) starting NS. After starting Seroquel Xr the patient began experiencing various side effects, including: Learning Disability, Hearing Impaired, Elevated Mood, Eating Disorder, Attention Deficit/hyperactivity Disorder, EpilepsyAdditional drugs used concurrently: NA. Although Seroquel Xr demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Learning Disability, may still occur.
Seroquel Side Effect Report#9925086
Orthostatic Hypotension, Anaemia, Hypothyroidism, Adverse Event, Off Label Use
This Orthostatic Hypotension problem was reported by a consumer or non-health professional from US. A 56-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: affective disorder,thyroid disorder. On 201311 this consumer started treatment with Seroquel (dosage: NA). The following drugs were being taken at the same time:
  • Dessicated Thyroid 0.5 Grains (Twice A Day)
  • Klonazepam
  • Aldasterone
  • Cortes
When using Seroquel, the patient experienced the following unwanted symptoms/side effects: Orthostatic Hypotension, Anaemia, Hypothyroidism, Adverse Event, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Orthostatic Hypotension, may become evident only after a product is in use by the general population.
Seroquel Side Effect Report#9924996
Road Traffic Accident, Insomnia, Somnolence, Sedation
This Road Traffic Accident side effect was reported by a consumer or non-health professional from US. A 53-year-old male patient (weight:NA) experienced the following symptoms/conditions: schizoaffective disorder,sleep disorder.The patient was prescribed Seroquel Xr (drug dosage: NA), which was initiated on 201311. Concurrently used drugs: NA..After starting to take Seroquel Xr the consumer reported adverse symptoms, such as: Road Traffic Accident, Insomnia, Somnolence, SedationThese side effects may potentially be related to Seroquel Xr.
Seroquel Side Effect Report#9924354
Large For Dates Baby
This is a report of a male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: depression, who was treated with Seroquel (dosage: NA, start time:
Jun 18, 2012), combined with: NA. and developed a serious reaction and side effect(s): Large For Dates Baby after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Seroquel treatment in male patients, resulting in Large For Dates Baby side effect.
Seroquel Side Effect Report#9913218
Agitation, Insomnia, Psychotic Disorder, No Therapeutic Response, Product Substitution Issue
This report suggests a potential Seroquel Agitation side effect(s) that can have serious consequences. A 50-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Seroquel (dosage: Qhs/bedtime) starting NS. After starting Seroquel the patient began experiencing various side effects, including: Agitation, Insomnia, Psychotic Disorder, No Therapeutic Response, Product Substitution IssueAdditional drugs used concurrently: NA. Although Seroquel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Agitation, may still occur.
Seroquel Side Effect Report#9908443
Clonus, Stress, Road Traffic Accident, Encephalopathy, Ataxia, Amyotrophic Lateral Sclerosis
This Clonus problem was reported by a pharmacist from US. A 41-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On NS this consumer started treatment with Seroquel (dosage: NA). The following drugs were being taken at the same time:
  • Prozac
  • Loestrin
When using Seroquel, the patient experienced the following unwanted symptoms/side effects: Clonus, Stress, Road Traffic Accident, Encephalopathy, Ataxia, Amyotrophic Lateral SclerosisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Clonus, may become evident only after a product is in use by the general population.
Seroquel Side Effect Report#9908050
Pneumonia, Thrombosis, Treatment Failure, Off Label Use
This Pneumonia side effect was reported by a consumer or non-health professional from BR. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: dementia alzheimer^s type,restlessness.The patient was prescribed Seroquel Xro (drug dosage: NA), which was initiated on 2012. Concurrently used drugs: NA..After starting to take Seroquel Xro the consumer reported adverse symptoms, such as: Pneumonia, Thrombosis, Treatment Failure, Off Label UseThese side effects may potentially be related to Seroquel Xro. The patient was hospitalized.
Seroquel Side Effect Report#9907296
Glycosylated Haemoglobin Increased, Glucose Urine, Blood Insulin Increased
This is a report of a 49-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: psychotic disorder,bipolar disorder, who was treated with Seroquel (dosage: 200 Mg, start time:
Oct 18, 2013), combined with:
  • Asenapine (10 Mg)
and developed a serious reaction and side effect(s): Glycosylated Haemoglobin Increased, Glucose Urine, Blood Insulin Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Seroquel treatment in male patients, resulting in Glycosylated Haemoglobin Increased side effect.


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The appearance of Seroquel on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Seroquel Side Effects for Women?

Women Side Effects Reports
Diabetes Mellitus 3555
Type 2 Diabetes Mellitus 2069
Insomnia 1384
Weight Increased 1141
Pancreatitis 1094
Blood Cholesterol Increased 1028
Obesity 775
Depression 654
Malaise 648
Diabetes Mellitus Inadequate Control 621

What are common Seroquel Side Effects for Men?

Men Side Effects Reports
Diabetes Mellitus 2475
Type 2 Diabetes Mellitus 1441
Insomnia 798
Pancreatitis 785
Blood Cholesterol Increased 647
Weight Increased 496
Diabetic Ketoacidosis 447
Diabetes Mellitus Inadequate Control 421
Hyperglycaemia 403
Diabetic Neuropathy 380

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Seroquel reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Seroquel Safety Alerts, Active Ingredients, Usage Information

    NDC 0310-0271
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name SEROQUEL
    Name Quetiapine fumarate
    Dosage Form TABLET, FILM COATED
    Route ORAL
    On market since 19971001
    Labeler AstraZeneca Pharmaceuticals LP
    Active Ingredient(s) QUETIAPINE FUMARATE
    Strength(s) 100
    Unit(s) mg/1
    Pharma Class Atypical Antipsychotic [EPC]

    Seroquel Dosage, Warnings, Usage.

    Side Effects reported to FDA: 27216

    Seroquel safety alerts: 2004 2002

    Reported deaths: 2320

    Reported hospitalizations: 7201

    Seroquel (quetiapine fumarate)

    Audience: Neuropsychiatric healthcare professionals

    FDA and AstraZeneca notified healthcare professionals of revision to the WARNINGS section of labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Seroquel. FDA has asked all manufacturers of atypical antipsychotic medications, including AstraZeneca, to add this Warning statement to labeling.

    [UPDATE - April 22, 2004 - Letter - AstraZeneca]
    [January 30, 2004 - Letter - AstraZeneca]
    [January 2004 Revised Label - AstraZeneca]

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