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Index of reports
> Life Threatening Events (18)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Paxil (Paroxetine) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Paxil side effects in 58 year old female
Reported by a physician from Japan on 2012-08-21
Patient: 58 year old female
Reactions: Torsade DE Pointes
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Alprazolam
Dosage: 0.4 mg, 3x/day
Administration route: Oral
Indication: Depression
End date: 2011-05-15
Paxil
Dosage: 10 mg, 3x/day
Administration route: Oral
Indication: Depression
Alprazolam
Dosage: 0.4 mg, 3x/day
Administration route: Oral
Indication: Depression
Start date: 2011-05-16
Akineton
Dosage: 2 mg, 3x/day
Administration route: Oral
Indication: Depression
Start date: 2011-05-14
End date: 2011-05-15
Fluvoxamine Maleate
Dosage: 75 mg, 3x/day
Administration route: Oral
Indication: Depression
End date: 2011-05-13
Biperiden Hydrochloride TAB
Dosage: 2 mg, 3x/day
Administration route: Oral
Indication: Depression
End date: 2011-05-13
Luvox
Dosage: 75 mg, 3x/day
Administration route: Oral
Indication: Depression
Start date: 2011-05-14
End date: 2011-05-15
Possible Paxil side effects in 58 year old female
Reported by a physician from Japan on 2012-08-02
Patient: 58 year old female
Reactions: Torsade DE Pointes, Syncope, Ventricular Tachycardia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Alprazolam
Dosage: 0.4 mg, 3x/day
Administration route: Oral
Indication: Depression
Start date: 2011-05-15
Paxil
Dosage: 10 mg, 3x/day
Administration route: Oral
Indication: Depression
Fluvoxamine Maleate
Dosage: 75 mg, 3x/day
Administration route: Oral
Indication: Depression
End date: 2011-05-14
Akineton
Dosage: 2 mg, 3x/day
Administration route: Oral
Indication: Depression
Start date: 2011-05-15
Alprazolam
Dosage: 0.4 mg, 3x/day
Administration route: Oral
Indication: Depression
End date: 2011-05-14
Luvox
Dosage: 75 mg, 3x/day
Administration route: Oral
Indication: Depression
Start date: 2011-05-15
Biperiden Hydrochloride TAB
Dosage: 2 mg, 3x/day
Administration route: Oral
Indication: Depression
End date: 2011-05-14
Possible Paxil side effects in 38 year old male
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: 38 year old male, weighing 74.8 kg (164.7 pounds)
Reactions: Economic Problem, Hallucination, Auditory, Amnesia, Aggression, Suicidal Ideation, Psychotic Disorder, Loss of Employment, Major Depression, Emotional Disorder, Feeling Abnormal
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02
Patient: male
Reactions: Dysmorphism, Head Circumference Abnormal, Congenital Central Nervous System Anomaly, Stillbirth, Micrognathia, Congenital Cardiovascular Anomaly, Cerebral Ventricle Dilatation, Hypotelorism of Orbit, Trisomy 18, Clinodactyly, Hydrocephalus, Congenital Nose Malformation, Amniotic Fluid Volume Increased, Hydronephrosis, Genitalia External Ambiguous, Cerebral Dysgenesis, Polyhydramnios, Renal Cyst, Brachycephaly, Umbilical Cord Abnormality, Nervous System Disorder, Dandy-Walker Syndrome, Small Size Placenta, Congenital Hand Malformation, Limb Malformation, Small FOR Dates Baby, Brain Malformation, Talipes, Apgar Score LOW, Exposure VIA Semen, Ventricular Septal Defect, Renal Aplasia, Bladder Disorder
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a physician from Japan on 2012-06-26
Patient: male
Reactions: Rash Generalised, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms, Toxic Skin Eruption, Loss of Consciousness
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lamictal
Dosage: 75mg per day
Administration route: Oral
Indication: Depression
Start date: 2012-03-30
End date: 2012-04-06
Lamictal
Dosage: 100mg per day
Administration route: Oral
Start date: 2012-04-07
Paxil
Dosage: 40mg per day
Administration route: Oral
Indication: Depression
Other drugs received by patient: Anafranil; Hirnamin; Abilify; Flunitrazepam; Cymbalta; Seroquel; Amoxapine; Amoban; Lithium Carbonate
Possible Paxil side effects in 35 year old female
Reported by a physician from Japan on 2012-06-11
Patient: 35 year old female
Reactions: Arrhythmia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Paxil
Dosage: 20mg per day
Administration route: Oral
Start date: 2010-12-27
End date: 2011-01-16
Paxil
Dosage: 40mg per day
Administration route: Oral
Start date: 2011-02-14
End date: 2011-05-22
Paxil
Dosage: 10mg per day
Administration route: Oral
Indication: Social Phobia
Start date: 2010-12-13
End date: 2010-12-26
Paxil
Dosage: 30mg per day
Administration route: Oral
Start date: 2011-01-17
End date: 2011-02-13
Other drugs received by patient: Unspecified Drug
Possible Paxil side effects in 68 year old female
Reported by a physician from United States on 2012-05-25
Patient: 68 year old female, weighing 84.0 kg (184.8 pounds)
Reactions: Serotonin Syndrome
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Wellbutrin
Dosage: oral
Administration route: Oral
Indication: Depression
Wellbutrin
Dosage: oral
Administration route: Oral
Indication: Anxiety
Fentanyl Citrate
Dosage: 100 mcg, 50 mcg
Indication: Product Used FOR Unknown Indication
Fentanyl Citrate
Dosage: 100 mcg, 50 mcg
Indication: Analgesic Therapy
Fentanyl Citrate
Dosage: 100 mcg, 50 mcg
Indication: Induction of Anaesthesia
Ondansetron
Dosage: 4 mg
Indication: Product Used FOR Unknown Indication
Cymbalta
Dosage: oral
Administration route: Oral
Indication: Anxiety
Cymbalta
Dosage: oral
Administration route: Oral
Indication: Depression
Paxil
Dosage: oral
Indication: Depression
Paxil
Dosage: oral
Indication: Anxiety
Other drugs received by patient: (Calcium); Fosamax; Lipitor; Fludrocortisone Acetate; Hydromorphone Hydrochloride; (Multivitamins / 00831701 / ); Propofol; Gabitril; Lisinopril; Levothyroxine Sodium; Oxycodone Hydrochloride; Gabapentin; (Triamterene and Hydrochlorthiazide); (Senna / 00142201 / ); Succinylcholine Chloride; Clonazepam; Omeprazole; Desflurane
Possible Paxil side effects in male
Reported by a physician from Japan on 2012-05-17
Patient: male
Reactions: Drug Rash With Eosinophilia and Systemic Symptoms, Loss of Consciousness
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Paxil
Dosage: 40mg per day
Administration route: Oral
Indication: Depression
Lamictal
Dosage: 200mg per day
Administration route: Oral
Indication: Depression
Other drugs received by patient: Cymbalta
Possible Paxil side effects in male
Reported by a lawyer from United States on 2012-05-09
Patient: male, weighing 3.4 kg (7.5 pounds)
Reactions: Atrial Septal Defect, Congenital Aortic Stenosis, Foetal Exposure During Pregnancy, Coarctation of THE Aorta, Pulmonary Artery Stenosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Paxil
Indication: Panic Attack
End date: 2007-06-01
Paxil CR
Dosage: 25mg per day
Indication: Panic Attack
End date: 2007-01-01
Possible Paxil side effects in male
Reported by a physician from United States on 2012-03-01
Patient: male, weighing 92.5 kg (203.6 pounds)
Reactions: Confusional State, Product Substitution Issue, Pruritus, Urticaria, Condition Aggravated, Suicidal Ideation, Discomfort, Depression
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Paxil
Indication: Depression
Start date: 2010-01-01
Bupropion Hydrochloride
Dosage: 150 mg tid oral
Administration route: Oral
Indication: Depression
Start date: 2012-01-03
Other drugs received by patient: Seroquel; Lithium Carbonate
Possible Paxil side effects in female
Reported by a physician from Japan on 2012-02-29
Patient: female
Reactions: Anaemia, Haemorrhagic Diathesis, Platelet Aggregation Decreased, Metrorrhagia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Paxil
Other drugs received by patient: Zolpidem; Rozerem; Doral
Possible Paxil side effects in female
Reported by a physician from Japan on 2012-01-31
Patient: female
Reactions: Pneumonia, Pneumonia Primary Atypical, Rales, Pyrexia, Headache, Chest X-RAY Abnormal, Dysarthria, Lung Disorder, Interstitial Lung Disease, Pleural Effusion, Tachypnoea, Hypoxia, Asthenia, Altered State of Consciousness, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Paxil
Other drugs received by patient: Chinese Medicine; PA; Alosenn; Astomin; Doral
Possible Paxil side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-27
Patient: female, weighing 88.5 kg (194.6 pounds)
Reactions: Agitation, Slow Speech, Impaired Work Ability, Abnormal Behaviour, Drug Withdrawal Syndrome, Suicidal Ideation, Dysarthria, Impaired Driving Ability, Panic Attack, Gastrointestinal Disorder, Gait Disturbance, Feeling Abnormal
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Paxil
Possible Paxil side effects in male
Reported by a lawyer from United States on 2012-01-09
Patient: male
Reactions: Pneumonia Aspiration, Foetal Exposure During Pregnancy, Tricuspid Valve Incompetence, Right Ventricular Hypertrophy, Pulmonary Artery Stenosis Congenital, Patent Ductus Arteriosus, Pulmonary Oedema, Apnoea, Breech Presentation, Gastrooesophageal Reflux Disease, Cardiac Failure Congestive, Atrial Septal Defect, Cardiac Murmur, Premature Baby, Ventricular Septal Defect, Congenital Pulmonary Hypertension, Bicuspid Aortic Valve, Left Atrial Dilatation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Paxil CR
Dosage: 20mg twice per day
Indication: Anxiety
Start date: 2005-12-01
End date: 2006-01-01
Paxil
Dosage: 20mg twice per day
Indication: Anxiety
Start date: 2005-11-01
End date: 2006-01-01
Other drugs received by patient: Trazodone HCL; Adalat; Feosol; Multi-Vitamins
Possible Paxil side effects in female
Reported by a individual with unspecified qualification from United States on 2011-12-28
Patient: female, weighing 45.4 kg (99.8 pounds)
Reactions: Product Formulation Issue, Movement Disorder, Speech Disorder, Product Quality Issue, Frequent Bowel Movements, Fear, Drug Dependence
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Paxil
Dosage: 5mg once a day
Start date: 2011-11-30
Paxil
Dosage: 5mg once a day
Start date: 2011-11-22
Possible Paxil side effects in 38 year old male
Reported by a individual with unspecified qualification from United States on 2011-12-23
Patient: 38 year old male, weighing 122.5 kg (269.4 pounds)
Reactions: Personality Change, Haemorrhage, Pain, Aphasia, Urinary Incontinence, Faecal Incontinence, Visual Acuity Reduced, Headache, Hyperhidrosis, Weight Increased, Suicide Attempt, Depressed Level of Consciousness, Dysgraphia, Withdrawal Syndrome, Feeling Abnormal
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Paxil
Dosage: 40 mg a day 047
Administration route: Oral
Indication: Depression
Start date: 1995-05-15
End date: 2004-01-26
Paxil
Dosage: 40 mg a day 047
Administration route: Oral
Indication: Post-Traumatic Stress Disorder
Start date: 1995-05-15
End date: 2004-01-26
Paxil
Possible Paxil side effects in male
Reported by a physician from Japan on 2011-12-15
Patient: male, weighing 74.2 kg (163.2 pounds)
Reactions: Off Label Use, Diabetic Ketoacidosis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Seroquel
Administration route: Oral
Indication: Depression
Start date: 2010-11-29
End date: 2011-01-13
Paxil
Administration route: Oral
Indication: Depression
Start date: 2010-11-26
Allopurinol
Administration route: Oral
Indication: Hyperlipidaemia
Start date: 2007-06-11
Livalo
Administration route: Oral
Indication: Hyperlipidaemia
Start date: 2007-06-11
Other drugs received by patient: Rohypnol; Desyrel
Possible Paxil side effects in male
Reported by a physician from Japan on 2011-12-01
Patient: male, weighing 74.2 kg (163.2 pounds)
Reactions: Off Label Use, Diabetic Ketoacidosis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Rohypnol
Administration route: Oral
Allopurinol
Administration route: Oral
Indication: Hyperlipidaemia
Start date: 2007-06-11
Desyrel
Administration route: Oral
Seroquel
Administration route: Oral
Indication: Depression
Start date: 2010-11-29
End date: 2011-01-13
Paxil
Administration route: Oral
Indication: Depression
Start date: 2010-11-26
Livalo
Administration route: Oral
Indication: Hyperlipidaemia
Start date: 2007-06-11
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