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 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 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 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 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 72 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 72 year old female, weighing 82.0 kg (180.4 pounds)
Reactions: Macular Degeneration
Drug(s) suspected as cause:
Zoloft
Dosage: 25 mg, 2x/day
Zoloft
Dosage: 25 mg, 1x/day
Indication: Anxiety
Other drugs received by patient: Atenolol
Possible Zoloft side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: female
Reactions: Anxiety, Insomnia, Nervousness
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: 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
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