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Seroquel (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 (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 (6349)
Death (282)
Life Threatening Events (315)
Disability (95)

Reports by Reaction Type

Drug Dose Omission (1904)Insomnia (1383)Off Label Use (1165)Malaise (739)Intentional Drug Misuse (531)Feeling Abnormal (471)Depression (463)Anxiety (423)Somnolence (406)Weight Increased (389)Drug Ineffective (319)Bipolar Disorder (307)

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

Possible Seroquel side effects in 60 year old male

Reported by a pharmacist from Australia on 2012-08-27

Patient: 60 year old male, weighing 64.0 kg (140.8 pounds)

Reactions: Tachycardia, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel

Other drugs received by patient possibly interacting with the suspect drug:
Claritin
    Administration route: Oral

Other drugs received by patient: Nexium; Avodart; Lipitor



Possible Seroquel side effects in 65 year old female

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

Patient: 65 year old female, weighing 52.2 kg (114.8 pounds)

Reactions: HIP Fracture, Malaise, Memory Impairment, Arthritis, Fall, Influenza

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Indication: Depression
    Start date: 2003-01-01

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Affective Disorder
    Start date: 2003-01-01

Seroquel
    Administration route: Oral

Other drugs received by patient: Fentanyl; Mobic; Clonazepam; Ambien; Trazodone Hydrochloride; Pravastatin; Trazodone Hydrochloride; Zolpidem



Possible Seroquel side effects in 36 year old female

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

Patient: 36 year old female, weighing 65.3 kg (143.7 pounds)

Reactions: Gallbladder Enlargement, Increased Upper Airway Secretion, Pneumonia, Vomiting, Pyrexia, Somnolence, Chronic Obstructive Pulmonary Disease, Loss of Consciousness, Sepsis, Abdominal Distension, Cough

Adverse event resulted in: life threatening event, hospitalization

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

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder

Symbicort
    Dosage: 160/4.5 mcg, 2 puffs, bid

Other drugs received by patient: Combivent; Clonazepam; Serrex Iron; Diltiazem



Possible Seroquel side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-27

Patient:

Reactions: Maternal Exposure During Pregnancy, Premature Labour, PRE-Eclampsia

Drug(s) suspected as cause:
Chlorpromazine HCL
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Anxiety
    Start date: 2011-09-22

Citalopram Hydrobromide
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Depression
    Start date: 2011-10-04

Dihydrocodeine Bitartrate INJ
    Administration route: Oral
    Indication: Pain
    Start date: 2010-03-15

Fluoxetine HCL
    Dosage: 60 mg, qd
    Indication: Depression
    Start date: 2010-06-21
    End date: 2011-10-04

Omeprazole
    Dosage: 20 mg, qd
    Administration route: Oral
    Indication: Dyspepsia
    Start date: 2008-09-19

Propranolol
    Dosage: 10 mg, bid
    Administration route: Oral
    Indication: Anxiety
    Start date: 2009-05-05

Seroquel
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: Depression
    Start date: 2011-03-23
    End date: 2011-09-10



Possible Seroquel side effects in 49 year old female

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

Patient: 49 year old female

Reactions: Drug Dose Omission, Off Label Use, Insomnia, Drug Withdrawal Syndrome, Blood Pressure Decreased, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel



Possible Seroquel side effects in 56 year old male

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

Patient: 56 year old male

Reactions: Drug Dose Omission, Adverse Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel



Possible Seroquel side effects in 277 month old female

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

Patient: 277 month old female, weighing 60.0 kg (132.0 pounds)

Reactions: Overdose, Bipolar Disorder, Insomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Start date: 2011-02-01

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2008-01-01

Other drugs received by patient: Magnesium Valproate



Possible Seroquel side effects in 55 year old female

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

Patient: 55 year old female, weighing 61.2 kg (134.6 pounds)

Reactions: Visual Impairment, Eye Disorder, Back Disorder

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

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel
    Administration route: Oral
    Indication: Depression

Seroquel
    Administration route: Oral

Other drugs received by patient: Ritalin; Trazodone Hydrochloride; Xanax



Possible Seroquel side effects in 90 year old male

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

Patient: 90 year old male

Reactions: Refusal of Treatment by Patient, Mutism, General Physical Health Deterioration, Pyrexia, Joint Injury, Death, Agranulocytosis, Hypophagia, Lower Gastrointestinal Haemorrhage, Oxygen Saturation Decreased

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Digoxin
    Administration route: Oral
    Start date: 2012-07-29
    End date: 2012-08-09

Digoxin
    Administration route: Oral
    Start date: 2012-07-03
    End date: 2012-07-17

Lansoprazole
    Administration route: Oral
    Start date: 2012-07-03
    End date: 2012-07-17

Seroquel
    Administration route: Oral
    Start date: 2012-07-14
    End date: 2012-07-16

Other drugs received by patient: Aspirin; Amlodipine



Possible Seroquel side effects in

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

Patient:

Reactions: Cataract

Drug(s) suspected as cause:
Seroquel



Possible Seroquel side effects in 48 year old male

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

Patient: 48 year old male

Reactions: Regurgitation, Drug Dose Omission, Drug Ineffective, Constipation, Off Label Use, Malaise, Impaired Self-Care, Gastrooesophageal Reflux Disease, Decreased Appetite, Stress, Gastric Disorder, Gastric Haemorrhage, Staphylococcal Infection, Bipolar Disorder, Sinus Disorder, Insomnia, Attention Deficit / Hyperactivity Disorder, Depressed Mood, Ulcer Haemorrhage

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

Prilosec
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Bipolar I Disorder

Seroquel
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder

Seroquel
    Administration route: Oral

Other drugs received by patient: Prevacid; Xanax; Adderall 10



Possible Seroquel side effects in 53 year old female

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

Patient: 53 year old female, weighing 84.4 kg (185.7 pounds)

Reactions: Intervertebral Disc Protrusion, Abasia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel

Other drugs received by patient: Depakote; Trizidine; Levothroid; Pravastatin; Levothyroxine Sodium; Laxative; Tramadol HCL; Lisinopril



Possible Seroquel side effects in 50 year old male

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

Patient: 50 year old male, weighing 55.8 kg (122.8 pounds)

Reactions: Thrombosis, Cerebral Infarction

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Indication: Delirium
    Start date: 2010-08-01

Seroquel
    Administration route: Oral
    End date: 2010-08-08



Possible Seroquel side effects in 59 year old female

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

Patient: 59 year old female

Reactions: Drug Dose Omission, Brain Injury, Brain Neoplasm Malignant, Impaired Work Ability, Lung Neoplasm, Fall, Suicidal Ideation

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

Seroquel
    Administration route: Oral
    Indication: Bipolar I Disorder



Possible Seroquel side effects in 48 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 48 year old female, weighing 113.9 kg (250.6 pounds)

Reactions: Nicotine Dependence, Vitamin D Deficiency, Generalised Anxiety Disorder, Pruritus, Intentional Drug Misuse, Treatment Noncompliance, Hypokalaemia, Suicidal Ideation, Fatigue, Oesophagitis, Obesity, Bacterial Infection, Oedema, Depression, Hallucination, Gastrooesophageal Reflux Disease, Cough, Migraine, Pain in Extremity, Musculoskeletal Pain, Vaginal Discharge, Self Injurious Behaviour, Dysmenorrhoea, Suicide Attempt, Vaginal Infection, Hypertension

Adverse event resulted in: life threatening event

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

Seroquel
    Administration route: Oral

Seroquel
    Dosage: 100mg 1/2 tab until monday then whole 100 mg
    Administration route: Oral

Other drugs received by patient: Prozac; Buspar; Albuterol; Naprosyn; Aspirin; Fluticasone Propionate; Hydrodiuril; K DUR / Klor-CON; Vistaril; Multi-Vitamin



Possible Seroquel side effects in male

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

Patient: male

Reactions: Herpes Ophthalmic, Hypomania, DRY Eye

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Start date: 2011-12-23
    End date: 2012-03-01

Seroquel
    Dosage: dose progressively increased to 300 mg per day
    Administration route: Oral
    Indication: Bipolar I Disorder
    Start date: 2011-11-15
    End date: 2011-12-22

Other drugs received by patient: Depakote; Lithium Carbonate; Lorazepam; Levothyroxine Sodium; Lamictal



Possible Seroquel side effects in male

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

Patient: male, weighing 2.2 kg (4.8 pounds)

Reactions: Neonatal Respiratory Distress Syndrome, Premature Baby, Hypocalcaemia, Pneumothorax, Drug Withdrawal Syndrome Neonatal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chlorpromazine
    Dosage: 25mg per day
    Indication: Anxiety
    Start date: 2011-09-22

Citalopram Hydrobromide
    Dosage: 20mg per day
    Indication: Depression
    Start date: 2011-10-04

Dihydrocodeine
    Dosage: 60mg per day
    Indication: Pain
    Start date: 2010-03-15

Fluoxetine
    Dosage: 60mg per day
    Indication: Depression
    Start date: 2010-06-21
    End date: 2011-10-04

Omeprazole
    Dosage: 20mg per day
    Indication: Dyspepsia
    Start date: 2008-09-19

Propranolol
    Dosage: 20mg per day
    Indication: Anxiety
    Start date: 2009-05-05

Propranolol
    Dosage: 20mg per day
    Indication: Palpitations
    Start date: 2009-05-05

Seroquel
    Dosage: 400mg per day
    Indication: Anxiety
    Start date: 2011-03-23
    End date: 2011-09-10

Seroquel
    Dosage: 400mg per day
    Indication: Depression
    Start date: 2011-03-23
    End date: 2011-09-10



Possible Seroquel side effects in 77 year old female

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

Patient: 77 year old female

Reactions: Hypomagnesaemia, Status Epilepticus, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levofloxacin
    Indication: Infection
    Start date: 2012-07-19
    End date: 2012-07-22

Nolotil
    Administration route: Oral
    Indication: Analgesic Therapy
    Start date: 2012-07-11
    End date: 2012-07-22

Omeprazole
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-06-03
    End date: 2012-07-22

Rifampin (Rifadin)
    Indication: Infection
    Start date: 2012-07-19
    End date: 2012-07-22

Seroquel
    Administration route: Oral
    Indication: Restlessness
    Start date: 2012-07-19
    End date: 2012-07-22

Toradol
    Indication: Analgesic Therapy
    Start date: 2012-07-19



Possible Seroquel side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-27

Patient: male, weighing 2.2 kg (4.8 pounds)

Reactions: Neonatal Respiratory Distress Syndrome, Premature Baby, Foetal Exposure During Pregnancy, Hypocalcaemia, Pneumothorax, Drug Withdrawal Syndrome Neonatal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chlorpromazine HCL

Citalopram Hydrobromide

Dihydrocodeine Bitartrate INJ

Fluoxetine HCL

Omeprazole

Propranolol

Seroquel



Possible Seroquel side effects in 56 year old female

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

Patient: 56 year old female

Reactions: Malaise, Systemic Lupus Erythematosus, Sinusitis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Seroquel



Possible Seroquel side effects in 60 year old male

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

Patient: 60 year old male, weighing 88.5 kg (194.7 pounds)

Reactions: Drug Dose Omission, Drug Effect Decreased, Insomnia, Adverse Event, Dizziness

Adverse event resulted in: hospitalization

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

Seroquel
    Administration route: Oral
    Start date: 2009-01-01

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2004-01-01
    End date: 2009-01-01

Other drugs received by patient: Simvastatin; Tegretol; Antidepressants; Benicar; Cholesterol Drug; Blood Pressure Medicine



Possible Seroquel side effects in male

Reported by a physician from France on 2012-08-24

Patient: male

Reactions: Intestinal Ischaemia, Pseudomonas Infection, Shock Haemorrhagic, Gastrointestinal Necrosis, Intestinal Obstruction, Multi-Organ Failure, Staphylococcal Abscess, Septic Shock, Cardiac Arrest, Candidiasis

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Depakine
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-06-25

Lepticur
    Administration route: Oral
    Start date: 2012-06-05
    End date: 2012-06-25

Loxapine HCL
    Administration route: Oral
    Indication: Aggression
    Start date: 2012-06-14
    End date: 2012-06-25

Seroquel
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-06-05
    End date: 2012-06-25

Valium
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-06-25



Possible Seroquel side effects in 74 year old female

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

Patient: 74 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Off Label Use, Dyspnoea, Nervousness

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Indication: Nervousness
    Start date: 2011-11-01

Seroquel
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2011-11-01

Symbicort
    Dosage: 160/4.5 mcg, 1 puffs two times daily

Symbicort
    Dosage: 160/4.5 mcg, 2 puffs two times daily
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-06-07

Other drugs received by patient: Trazidone; Xanax; Ventolin; Dulcolax; Protonic; Aspirin; Paxil; Lasix



Possible Seroquel 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: Pain in Extremity, Headache

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

Symbicort

Toprol-XL
    Administration route: Oral



Possible Seroquel side effects in 32 year old female

Reported by a physician from United States on 2012-08-24

Patient: 32 year old female

Reactions: Migraine, Weight Decreased, Schizoaffective Disorder, Nasal Congestion, Oropharyngeal Pain, Suicidal Ideation, Hallucinations, Mixed, Overdose, Activities of Daily Living Impaired, Visual Impairment, Suicide Attempt, Depression, Depressed Mood, Hallucination, Decreased Appetite

Adverse event resulted in: life threatening event, hospitalization

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

Seroquel
    Administration route: Oral

Other drugs received by patient: Topamax; Vicodin; Ativan; Effexor



Possible Seroquel side effects in 46 year old female

Reported by a physician from Australia on 2012-08-24

Patient: 46 year old female

Reactions: Off Label Use, Electrocardiogram QT Prolonged, Ventricular Fibrillation

Adverse event resulted in: life threatening event, hospitalization, disablity

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

Seroquel
    Administration route: Oral

Other drugs received by patient: Opiates; Reboxetine



Possible Seroquel side effects in 63 year old male

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

Patient: 63 year old male, weighing 72.6 kg (159.7 pounds)

Reactions: Off Label Use, Middle Insomnia, Bipolar Disorder, Pollakiuria

Drug(s) suspected as cause:
Depakote
    Indication: Depression
    Start date: 1995-01-01

Lorazepam
    Indication: Sleep Disorder

Seroquel
    Administration route: Oral
    Indication: Depression
    Start date: 2010-01-01

Seroquel
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2010-01-01

Symbicort
    Dosage: 160/4.5 mcg, two times a day
    Indication: Asthma
    Start date: 2011-05-01

Other drugs received by patient: Wellbutrin; Generic Xanax; Generic Xanax



Possible Seroquel side effects in male

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

Patient: male

Reactions: Anxiety, Suicidal Behaviour, Adverse Event, Depression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel



Possible Seroquel side effects in 41 year old male

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

Patient: 41 year old male

Reactions: Upper Respiratory Fungal Infection, Drug Ineffective, Ill-Defined Disorder, Oral Fungal Infection

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

Seroquel
    Administration route: Oral

Symbicort
    Dosage: unknown strength and frequency

Toprol-XL
    Administration route: Oral

Other drugs received by patient: Lisinopril



Possible Seroquel side effects in 634 month old female

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

Patient: 634 month old female, weighing 62.1 kg (136.6 pounds)

Reactions: Diabetes Mellitus, Intentional Drug Misuse, Amnesia, Aphonia

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-07-01
    End date: 2012-03-01

Seroquel
    Administration route: Oral
    Start date: 2012-03-01

Symbicort
    Dosage: 160/4.5 mcg two times a day
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Vitamin D; Fasomax; Pravastatin; Vitamin B1 TAB; Celexa; Ventolin HFA

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