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Seroquel XR (Quetiapine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Seroquel XR (Quetiapine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (2600)
Death (73)
Life Threatening Events (89)
Disability (34)

Reports by Reaction Type

Drug Dose Omission (806)Insomnia (469)Off Label Use (351)Malaise (297)Intentional Drug Misuse (209)Depression (171)Feeling Abnormal (167)Anxiety (153)Somnolence (136)Bipolar Disorder (135)Adverse Event (132)Weight Increased (128)

Below are a few examples of reports where side effects / adverse reactions may be related to Seroquel XR (Quetiapine). For a complete list or a specific selection of reports, please use the links above.

Possible Seroquel XR side effects in 46 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-27

Patient: 46 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Off Label Use, Poor Quality Sleep, Foot Deformity, Drug Dose Omission, Middle Insomnia, Dysstasia, Insomnia, Adverse Event

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Mania

Seroquel XR
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel XR
    Administration route: Oral
    Indication: Sleep Disorder

Other drugs received by patient: Celexa



Possible Seroquel XR side effects in

Reported by a physician from United States on 2012-08-27

Patient:

Reactions: Electrocardiogram QT Prolonged

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
3 Different Benzodiaziepines

Seroquel XR
    Administration route: Oral



Possible Seroquel XR side effects in 44 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 44 year old male

Reactions: Accident, Mucosal Ulceration, Bipolar Disorder, Spinal Fracture, Dementia Alzheimer's Type, Adverse Event, Fall, Prostatic Disorder, RIB Fracture

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Other drugs received by patient: Levaquin; Armodafinil; Zithromax



Possible Seroquel XR side effects in 23 year old female

Reported by a physician from Germany on 2012-08-27

Patient: 23 year old female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Seroquel XR



Possible Seroquel XR side effects in 67 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-27

Patient: 67 year old female, weighing 49.9 kg (109.8 pounds)

Reactions: Therapeutic Response Unexpected, Intentional Drug Misuse, Pyrexia, Meniere's Disease, Accident, Hyperventilation, Adverse Event, Infection

Drug(s) suspected as cause:
Seroquel XR

Other drugs received by patient: Mirtazapine; Alprazolam; Gabapentin



Possible Seroquel XR side effects in 50 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 50 year old female

Reactions: Tourette's Disorder

Drug(s) suspected as cause:
Seroquel XR



Possible Seroquel XR side effects in 42 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 42 year old male

Reactions: Respiratory Disorder

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral

Symbicort

Other drugs received by patient: Proventil



Possible Seroquel XR side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 54 year old female

Reactions: Anxiety, Anxiety Disorder, Gastrooesophageal Reflux Disease, Nervousness

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Other drugs received by patient: Lamictal; Klonopin; Pristiq



Possible Seroquel XR side effects in 66 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 66 year old male

Reactions: Adverse Event

Drug(s) suspected as cause:
Seroquel XR



Possible Seroquel XR side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 46 year old female

Reactions: Limb Discomfort

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral

Symbicort



Possible Seroquel XR side effects in 45 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 45 year old female, weighing 75.8 kg (166.8 pounds)

Reactions: Wrist Fracture, Fall

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel XR
    Administration route: Oral
    Indication: Anxiety Disorder

Seroquel XR
    Administration route: Oral
    Indication: Sleep Disorder

Other drugs received by patient: Ibuprofen; Regular Vitamins



Possible Seroquel XR side effects in 29 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 29 year old male

Reactions: Fatigue, Aversion

Drug(s) suspected as cause:
Seroquel XR



Possible Seroquel XR side effects in 48 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 48 year old female, weighing 61.7 kg (135.7 pounds)

Reactions: Anxiety, Drug Ineffective, Chronic Obstructive Pulmonary Disease

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Bipolar Disorder

Symbicort
    Dosage: 2 puffs bid
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Albuterol; Trazidone; Xanax; Paxil; Dopanex; Oxygen; Lisinopril



Possible Seroquel XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Drug Dose Omission, Dyspnoea, Chest Discomfort, Psychomotor Hyperactivity, Insomnia

Drug(s) suspected as cause:
Seroquel XR



Possible Seroquel XR side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 49 year old female

Reactions: Chronic Obstructive Pulmonary Disease

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral

Symbicort



Possible Seroquel XR side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 47 year old female, weighing 102.1 kg (224.6 pounds)

Reactions: Migraine, Weight Increased, Drug Dose Omission, Anxiety, Diarrhoea, Adverse Event, Feeling Abnormal

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Depression

Seroquel XR
    Administration route: Oral
    Indication: Bipolar Disorder

Other drugs received by patient: Nexium; Abilify; Restoril; Depakote; Celexa



Possible Seroquel XR side effects in 64 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-23

Patient: 64 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Asthma, Osteoporosis, Drug Ineffective, Somnolence, Weight Increased, Off Label Use, Malaise, DRY Mouth, Adverse Event, Depression, Lethargy, Aphagia, Dyspnoea, Nightmare, Dysphagia, Nasal Congestion, Swollen Tongue, Seasonal Allergy, Activities of Daily Living Impaired, Insomnia, Altered State of Consciousness

Drug(s) suspected as cause:
Seroquel XR
    Dosage: 300 mg, cut into two
    Administration route: Oral

Seroquel XR
    Administration route: Oral
    Indication: Depression

Seroquel XR
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel XR
    Dosage: 300 mg, cut into two
    Administration route: Oral

Seroquel XR
    Dosage: 300 mg, cut into two
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral
    Indication: Sleep Disorder

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Other drugs received by patient: Meloxicam; Fluticasone Propionate; Xanax; Celexa; Synthroid; Gabapentin; Buspar; Fosamax



Possible Seroquel XR side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 59 year old female

Reactions: Drug Dose Omission, Tachyphrenia, Headache, Intentional Drug Misuse, Anxiety, Insomnia, Depression, Crying

Drug(s) suspected as cause:
Seroquel XR

Other drugs received by patient: Citilopram; Wellbutrin



Possible Seroquel XR side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 50 year old male

Reactions: Drug Dose Omission, Adverse Event

Drug(s) suspected as cause:
Seroquel XR



Possible Seroquel XR side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 64 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Asthma, Osteoporosis, Drug Ineffective, Somnolence, Weight Increased, Off Label Use, Malaise, DRY Mouth, Adverse Event, Depression, Lethargy, Aphagia, Dysphagia, Dyspnoea, Nightmare, Swollen Tongue, Nasal Congestion, Seasonal Allergy, Activities of Daily Living Impaired, Insomnia, Altered State of Consciousness

Drug(s) suspected as cause:
Seroquel XR
    Dosage: 300 mg, cut into two
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral
    Indication: Depression

Seroquel XR
    Dosage: 300 mg, cut into two
    Administration route: Oral

Seroquel XR
    Dosage: 300 mg, cut into two
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral
    Indication: Sleep Disorder

Seroquel XR
    Administration route: Oral
    Indication: Bipolar Disorder

Other drugs received by patient: Buspar; Gabapentin; Fluticasone Propionate; Xanax; Celexa; Fosamax; Meloxicam; Synthroid



Possible Seroquel XR side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 49 year old female

Reactions: Snake Bite, Respiratory Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Insomnia

Seroquel XR
    Administration route: Oral
    Indication: Bipolar Disorder



Possible Seroquel XR side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 49 year old female

Reactions: Anxiety, Stress

Drug(s) suspected as cause:
Seroquel XR



Possible Seroquel XR side effects in 64 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-23

Patient: 64 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Asthma, Osteoporosis, Drug Ineffective, Somnolence, Off Label Use, Weight Increased, Malaise, DRY Mouth, Adverse Event, Depression, Lethargy, Aphagia, Dysphagia, Nightmare, Dyspnoea, Nasal Congestion, Swollen Tongue, Seasonal Allergy, Activities of Daily Living Impaired, Insomnia, Altered State of Consciousness

Drug(s) suspected as cause:
Seroquel XR
    Dosage: 300 mg, cut into two
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel XR
    Dosage: 300 mg, cut into two
    Administration route: Oral

Seroquel XR
    Administration route: Oral
    Indication: Depression

Seroquel XR
    Administration route: Oral
    Indication: Sleep Disorder

Seroquel XR
    Dosage: 300 mg, cut into two
    Administration route: Oral

Other drugs received by patient: Celexa; Xanax; Gabapentin; Meloxicam; Synthroid; Fosamax; Buspar; Fluticasone Propionate



Possible Seroquel XR side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 49 year old female

Reactions: Bipolar Disorder, Personality Disorder

Drug(s) suspected as cause:
Seroquel XR



Possible Seroquel XR side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 54 year old female, weighing 67.6 kg (148.7 pounds)

Reactions: Agitation, Radiation Injury, Schizophrenia, Headache, Abdominal Discomfort, Off Label Use, Malaise, Deafness Unilateral, Oedema Peripheral, Hepatic Infection, Mouth Haemorrhage, Crohn's Disease, Immunodeficiency, Convulsion, Hallucination, Visual, Staphylococcal Infection, Swelling, Liver Tenderness, Anosmia, Intentional Drug Misuse, Fall, Haematemesis, Abdominal Pain Upper, Hypoacusis, Cancer in Remission, Dizziness, Myocardial Infarction, Dyspnoea, Vomiting, Swelling Face, Cervix Carcinoma Stage IV, Amnesia, Diarrhoea, Neoplasm Malignant, Ageusia, Bipolar Disorder, Visual Impairment, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chemotherapy
    Start date: 1993-01-01

Chemotherapy
    Start date: 2000-01-01

Chemotherapy
    Start date: 1996-01-01

Chemotherapy
    Start date: 1987-01-01

Chemotherapy
    Start date: 1995-01-01

Chemotherapy
    Start date: 1999-01-01

Radiation
    Start date: 1993-01-01

Radiation
    Start date: 1999-01-01

Radiation
    Start date: 1987-01-01

Radiation
    Start date: 1995-01-01

Radiation
    Start date: 1996-01-01

Radiation
    Start date: 2000-01-01

Seroquel XR
    Administration route: Oral
    Indication: Transient Ischaemic Attack
    Start date: 2002-01-01

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2002-01-01

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral
    Indication: Anxiety
    Start date: 2002-01-01

Seroquel XR
    Administration route: Oral
    Indication: Depression
    Start date: 2002-01-01

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2002-01-01

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral

Other drugs received by patient: Fluticasone Tropionate; 18 Different Pills; Hydrochlorothiazide; Valium; Ciprofloxacin; Potassium; Gabapentin; Ventolin



Possible Seroquel XR side effects in 534 month old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 534 month old female, weighing 77.1 kg (169.6 pounds)

Reactions: Off Label Use, Back Pain, Weight Increased, Arthralgia

Drug(s) suspected as cause:
Seroquel XR
    Dosage: 25 mg by taking 1/2 tablet of 50 mg, at night
    Administration route: Oral
    Start date: 2012-06-01

Seroquel XR
    Administration route: Oral
    Indication: Sleep Disorder Therapy
    Start date: 2012-02-01
    End date: 2012-06-01

Seroquel XR
    Dosage: split tablet to 12.5 mg, two times a day
    Administration route: Oral



Possible Seroquel XR side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 65 year old female

Reactions: Agitation, Pain, Adverse Event, Mental Disorder, Headache, Hypertension, Nervousness

Drug(s) suspected as cause:
Seroquel XR



Possible Seroquel XR side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 62 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Migraine, Drug Dose Omission, Vomiting, Nightmare, Fall, Delusion, Thinking Abnormal, Bipolar Disorder, Diarrhoea, Feeling Jittery, Insomnia, Gait Disturbance, Bradyphrenia, RIB Fracture, Decreased Appetite

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel XR
    Administration route: Oral

Seroquel XR
    Administration route: Oral
    Start date: 2008-01-01
    End date: 2011-04-17

Other drugs received by patient: Flurazepam HCL; Lamictal; Paxil; Generic OF Valium



Possible Seroquel XR side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Pain, Insomnia, Blood Pressure, Skin Disorder, Gastrooesophageal Reflux Disease, Herpes Zoster, Tremor

Drug(s) suspected as cause:
Seroquel XR
    Administration route: Oral
    Indication: Depression
    Start date: 2010-09-23

Symbicort
    Dosage: 160/45 mcg two inhalations twice daily
    Indication: Asthma
    Start date: 2009-09-30

Toprol-XL
    Administration route: Oral
    Start date: 2005-03-07

Other drugs received by patient: Metrogel; Gabapentin; Gabapentin; Ambien; Victoza; Zovirax; Lansoprazole; Lasix; Lopid; Losartan Potassium; Pravachol; Spironolactone; Cartia XT; Cymbalta; Propranolol; Trazodone HCL; Aspirin; Atrovent; Bupropion HCL; Hydrocodone Bitartrate and Acetaminophen; Mobic; Ventolin HFA



Possible Seroquel XR side effects in 54 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: 54 year old male, weighing 105.2 kg (231.4 pounds)

Reactions: Asthma, Drug Dose Omission, Suicidal Behaviour, Haemorrhoids, Mood Swings, Depression, Suicidal Ideation

Drug(s) suspected as cause:
Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2010-01-01

Seroquel XR
    Administration route: Oral
    Indication: Anxiety

Seroquel XR
    Administration route: Oral
    Indication: Depression

Other drugs received by patient: Alprazolam; Fluticasone Propionate / Salmeterol; Lisinopril; Prozac; Singulair

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