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Zoloft (Sertraline) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zoloft (Sertraline) 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 (2956)
Death (264)
Life Threatening Events (130)
Disability (79)

Reports by Reaction Type

Maternal Exposure Timing Unspecified (602)Atrial Septal Defect (338)Foetal Exposure During Pregnancy (267)Patent Ductus Arteriosus (227)Ventricular Septal Defect (223)Drug Ineffective (211)Tricuspid Valve Incompetence (182)Cardiomegaly (165)Depression (157)Heart Disease Congenital (151)Anxiety (149)Congenital Anomaly (131)

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

Possible Zoloft side effects in male

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

Patient: male, weighing 3.4 kg (7.4 pounds)

Reactions: Atrial Septal Defect, Neonatal Respiratory Distress Syndrome, Pulmonary Valve Stenosis, Hypertension Neonatal, Ventricular Septal Defect, Right Ventricle Outflow Tract Obstruction, Maternal Exposure Timing Unspecified, Pulmonary Artery Atresia, Fallot's Tetralogy, Congenital Anomaly, Sepsis Neonatal, Pneumothorax, Heart Disease Congenital, Pneumopericardium

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Zoloft
    Dosage: 100mg half dose (1/2) daily
    Start date: 2000-12-12

Zoloft
    Dosage: one and half dose daily
    Start date: 2001-01-02

Zoloft
    Dosage: half dose of 100 mg and then increased to one and half dose daily
    Start date: 2002-03-06

Other drugs received by patient: Multi-Vitamins; Ceflex



Possible Zoloft side effects in 84 year old female

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

Patient: 84 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Macular Degeneration

Drug(s) suspected as cause:
Zoloft

Other drugs received by patient: Aspirin; Amlodipine; Zetia



Possible Zoloft side effects in 5 year old

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

Patient: 5 year old

Reactions: Maternal Exposure Timing Unspecified, Convulsion

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in 54 year old female

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

Patient: 54 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Osteoporosis

Drug(s) suspected as cause:
Lipitor
    Dosage: 40 mg, daily
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Zoloft
    Dosage: 50 mg, daily
    Indication: Depression

Other drugs received by patient: Acetylsalicylic Acid; Celebrex; Micardis; Celebrex; Celebrex; Metformin



Possible Zoloft side effects in female

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

Patient: female, weighing 2.9 kg (6.4 pounds)

Reactions: Atrial Septal Defect, Aortic Stenosis, Left Ventricular Hypertrophy, Ventricular Septal Defect, Tricuspid Valve Incompetence, Maternal Exposure Timing Unspecified, Transposition of THE Great Vessels, Pulmonary Artery Stenosis Congenital, Pulmonary Oedema Neonatal, Atelectasis Neonatal, Right Atrial Dilatation, Mitral Valve Incompetence, Heart Disease Congenital

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zoloft
    Indication: Depression

Zoloft
    Dosage: 50 mg, 1x/day
    Indication: Anxiety
    Start date: 2003-10-23

Zoloft
    Indication: Affective Disorder

Other drugs received by patient: Ferrous Fumarate; Promethazine; Multi-Vitamins; Zyrtec; Vitamin B6; Folic Acid; Promethazine; Robitussin A-C / OLD Form /; Amoxil



Possible Zoloft side effects in female

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

Patient: female

Reactions: Maternal Exposure During Pregnancy, Premature Labour

Drug(s) suspected as cause:
Risperdal
    Indication: Depression

Zoloft
    Indication: Depression



Possible Zoloft side effects in female

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

Patient: female

Reactions: Renal Failure, Hernia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Glucotrol XL
    Dosage: unk

Lipitor
    Dosage: unk

Neurontin
    Dosage: unk

Zoloft
    Dosage: unk



Possible Zoloft side effects in female

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

Patient: female

Reactions: Abnormal Dreams, Arthralgia, Chronic Obstructive Pulmonary Disease

Drug(s) suspected as cause:
Celebrex
    Dosage: unk

Norvasc
    Dosage: unk

Spiriva
    Dosage: unk

Zoloft
    Dosage: unk



Possible Zoloft side effects in 86 year old female

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

Patient: 86 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Drug Effect Decreased, Epistaxis

Drug(s) suspected as cause:
Zoloft
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Start date: 2011-08-01

Zoloft
    Dosage: 50 mg, 1x/day
    Administration route: Oral
    Indication: Depression
    Start date: 2004-01-01
    End date: 2011-08-01

Other drugs received by patient: Zetia; Amlodipine; Aspirin



Possible Zoloft side effects in male

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

Patient: male, weighing 2.4 kg (5.3 pounds)

Reactions: Head LAG, Dysmorphism, Congenital Central Nervous System Anomaly, Bundle Branch Block Right, Micrognathia, Tricuspid Valve Incompetence, Hypospadias, Cerebral Haemorrhage, Cardiomegaly, Cerebral Ischaemia, Patent Ductus Arteriosus, Congenital Anomaly, Pulmonary Vascular Disorder, Congenital Nose Malformation, Mitral Valve Prolapse, Pulmonary Valve Stenosis, Arachnodactyly, Maternal Exposure Timing Unspecified, Convulsion, Digeorge's Syndrome, Fallot's Tetralogy, Otitis Media, Aortic Valve Incompetence, Inguinal Hernia, Double Outlet Right Ventricle, Right Ventricular Hypertrophy, Failure To Thrive, Small FOR Dates Baby, Neck Deformity, Right Aortic Arch, Atrial Septal Defect, Speech Disorder Developmental, Motor Dysfunction, Pachygyria, Penile Torsion, Ventricular Septal Defect, Cognitive Disorder, Pulmonary Artery Atresia, Pulmonary Valve Incompetence, Respiratory Failure, Shwachman-Diamond Syndrome, Mitral Valve Incompetence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zoloft
    Dosage: 50 unknown units, unk
    Start date: 2004-03-01

Zoloft
    Dosage: 50 mg, half tablet per day
    Indication: Depression
    Start date: 2003-05-21

Other drugs received by patient: Albuterol; Multi-Vitamins; Diphenhydramine; Prednisone



Possible Zoloft side effects in female

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

Patient: female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal
    Indication: Depression

Zoloft
    Indication: Depression



Possible Zoloft side effects in female

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

Patient: female

Reactions: Hallucination, Drug Dependence, Tremor

Drug(s) suspected as cause:
Zoloft
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Depression
    Start date: 2012-03-01
    End date: 2012-01-01

Zoloft
    Indication: Anxiety



Possible Zoloft side effects in female

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

Patient: female

Reactions: Macular Degeneration, Blindness

Drug(s) suspected as cause:
Caduet
    Dosage: unk

Zoloft
    Dosage: unk



Possible Zoloft side effects in 46 year old male

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

Patient: 46 year old male

Reactions: Drug Ineffective, Pain, Gastric Disorder

Drug(s) suspected as cause:
Lyrica
    Dosage: 75 mg, 3x/day
    Administration route: Oral

Neurontin
    Dosage: unk
    Indication: Neuropathy Peripheral

Zoloft
    Dosage: 50 mg, 1x/day
    Administration route: Oral



Possible Zoloft side effects in female

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

Patient: female

Reactions: Vomiting, Intentional Overdose, Unresponsive To Stimuli, Abnormal Behaviour, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lanoxin
    Dosage: 6 vials
    Start date: 2012-07-12

Voltaren
    Dosage: 60 df, unk
    Administration route: Oral
    Start date: 2012-07-12
    End date: 2012-07-12

Zoloft
    Dosage: 120 df, unk
    Administration route: Oral
    Start date: 2012-07-12
    End date: 2012-07-12

Zolpidem
    Dosage: 60 df, unk
    Administration route: Oral
    Start date: 2012-07-12
    End date: 2012-07-12



Possible Zoloft side effects in female

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

Patient: female

Reactions: Asthma, Respiratory Disorder, Cardiac Murmur, Premature Baby, Rash, Constipation, Faecaloma, Pulmonary Artery Stenosis Congenital, Mitral Valve Incompetence, Multiple Allergies, Heart Disease Congenital, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Risperdal
    Indication: Foetal Exposure During Pregnancy

Zoloft
    Indication: Foetal Exposure During Pregnancy



Possible Zoloft side effects in 6 year old

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

Patient: 6 year old

Reactions: Maternal Exposure Timing Unspecified, Convulsion

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in male

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

Patient: male

Reactions: Brain Neoplasm Malignant, Diabetes Mellitus, Lung Neoplasm Malignant, Blood Cholesterol Increased, Depression, Hypertension

Drug(s) suspected as cause:
Dilantin-125
    Dosage: unk

Lipitor
    Dosage: unk

Zoloft
    Dosage: unk



Possible Zoloft side effects in male

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

Patient: male

Reactions: Multiple Cardiac Defects, Maternal Exposure Timing Unspecified

Adverse event resulted in: death

Drug(s) suspected as cause:
Sertraline Hydrochloride
    Indication: Depression

Sertraline Hydrochloride
    Dosage: unk
    Indication: Anxiety

Sertraline Hydrochloride
    Indication: Affective Disorder

Zoloft
    Indication: Affective Disorder

Zoloft
    Indication: Depression

Zoloft
    Dosage: unk
    Indication: Anxiety



Possible Zoloft side effects in 93 year old male

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

Patient: 93 year old male, weighing 38.0 kg (83.6 pounds)

Reactions: Pneumonia, Cardiac Failure, Sepsis, Inappropriate Antidiuretic Hormone Secretion

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

Drug(s) suspected as cause:
Zoloft

Other drugs received by patient: Linbulane; Famotidine; Tamsulosin HCL; Lorazepam; Lendormin; SG Combination Granules



Possible Zoloft side effects in female

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

Patient: female

Reactions: Oligohydramnios, Maternal Exposure During Pregnancy, Perineal Laceration, Emotional Disorder, Epilepsy

Drug(s) suspected as cause:
Brethine
    Indication: Product Used FOR Unknown Indication

Bupivacaine HCL
    Indication: Product Used FOR Unknown Indication

Colace
    Indication: Product Used FOR Unknown Indication

Effexor
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Fentanyl
    Indication: Product Used FOR Unknown Indication

Hydroxyzine
    Dosage: as necessary
    Administration route: Oral
    Indication: Anxiety

Ibuprofen
    Indication: Product Used FOR Unknown Indication

Ibuprofen

Metformin HCL
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Mirtazapine
    Administration route: Oral
    Indication: Depression

Oxytocin
    Indication: Product Used FOR Unknown Indication

Topamax
    Administration route: Oral
    Indication: Convulsion
    Start date: 2006-09-18
    End date: 2006-12-18

Topamax
    Administration route: Oral
    Indication: Migraine
    Start date: 2006-09-18
    End date: 2006-12-18

Trazodone Hydrochloride
    Administration route: Oral
    Indication: Depression

Zoloft
    Administration route: Oral
    Indication: Antidepressant Therapy

Other drugs received by patient: Folic Acid; Ferrous Sulfate TAB; Risedronate Sodium; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP



Possible Zoloft side effects in 58 year old female

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

Patient: 58 year old female, weighing 74.8 kg (164.6 pounds)

Reactions: Anxiety, Drug Ineffective

Drug(s) suspected as cause:
Zoloft
    Indication: Mood Swings

Zoloft
    Dosage: unk
    Indication: Depression



Possible Zoloft 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, weighing 79.0 kg (173.8 pounds)

Reactions: Nicotinamide Decreased, Arthralgia, Depression, Gait Disturbance, Fall, Somnolence, Joint Injury, Crying

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

Zoloft
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Depression
    Start date: 2001-01-01

Zoloft
    Dosage: 100 mg, 1x/day
    Administration route: Oral

Other drugs received by patient: Bupropion; Spiriva; Diltiazem; Hydrocodone Bitartrate + Acetaminophen; Simvastatin; Niaspan; Soma



Possible Zoloft side effects in male

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

Patient: male

Reactions: Tendon Rupture, Fall

Drug(s) suspected as cause:
Lipitor
    Dosage: unk

Zoloft
    Dosage: unk



Possible Zoloft side effects in female

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

Patient: female

Reactions: Speech Disorder, Cleft LIP and Palate, Foetal Growth Restriction, Foetal Heart Rate Abnormal, Otitis Media Chronic, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bupivacaine HCL
    Indication: Foetal Exposure During Pregnancy

Colace
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Fentanyl
    Indication: Foetal Exposure During Pregnancy

Hydroxyzine
    Indication: Foetal Exposure During Pregnancy

Ibuprofen
    Indication: Foetal Exposure During Pregnancy

Ibuprofen

Mirtazapine
    Indication: Foetal Exposure During Pregnancy

Oxytocin
    Indication: Foetal Exposure During Pregnancy

Terbutaline
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Trazodone Hydrochloride
    Indication: Foetal Exposure During Pregnancy

Zoloft
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Multi-Vitamins; Metformin HCL; Risedronate Sodium; Folic Acid; Ferrous Sulfate TAB



Possible Zoloft side effects in female

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

Patient: female

Reactions: Weight Decreased, Skin Exfoliation, Alopecia, Blister

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in female

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

Patient: female

Reactions: Anxiety

Drug(s) suspected as cause:
Zoloft



Possible Zoloft side effects in 69 year old female

Reported by a physician from United States on 2012-08-23

Patient: 69 year old female, weighing 51.2 kg (112.7 pounds)

Reactions: Mental Impairment, Dissociation, Disturbance in Attention, Feeling Abnormal

Drug(s) suspected as cause:
Zoloft

Other drugs received by patient: Xanax



Possible Zoloft side effects in female

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

Patient: female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Lipitor
    Dosage: unk

Lyrica
    Dosage: unk

Zoloft
    Dosage: unk



Possible Zoloft side effects in female

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

Patient: female

Reactions: Depressed Mood

Drug(s) suspected as cause:
Zoloft

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