Common Zoloft Side Effects


The most commonly reported Zoloft side effects (click to view or check a box to report):

Anxiety (555)
Depression (517)
Atrial Septal Defect (341)
Insomnia (338)
Feeling Abnormal (330)
Dizziness (326)
Nausea (307)
Headache (290)
Fatigue (257)
Asthenia (213)
Diarrhoea (205)
Suicidal Ideation (198)
Agitation (189)
Patent Ductus Arteriosus (188)
Ventricular Septal Defect (187)
Tremor (185)
Pain (173)
Fall (172)
Convulsion (170)
Condition Aggravated (160)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Zoloft Side Effects Reported to FDA



Zoloft Side Effect Report#9983136
Dizziness, Fall, Fibula Fracture, Abdominal Discomfort
This is a report of a 52-year-old female patient (weight: NA) from PE, suffering from the following health symptoms/conditions: NA, who was treated with Zoloft (dosage: Unk, start time: NS), combined with:
  • Neuryl (Unk)
  • Calcium (Unk)
and developed a serious reaction and side effect(s): Dizziness, Fall, Fibula Fracture, Abdominal Discomfort after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zoloft treatment in female patients, resulting in Dizziness side effect.
Zoloft Side Effect Report#9975929
Glucose Tolerance Impaired, Hypertriglyceridaemia, Overweight
This report suggests a potential Zoloft Glucose Tolerance Impaired side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Zoloft (dosage: Unk) starting NS. After starting Zoloft the patient began experiencing various side effects, including: Glucose Tolerance Impaired, Hypertriglyceridaemia, OverweightAdditional drugs used concurrently:
  • Norvasc (Unk)
  • Neurontin (Unk)
  • Daypro (Unk)
Although Zoloft demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Glucose Tolerance Impaired, may still occur.
Zoloft Side Effect Report#9964377
Interstitial Lung Disease, Malaise
This Interstitial Lung Disease problem was reported by a physician from CN. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On 201402 this consumer started treatment with Zoloft (dosage: 50 Mg, One To Two Times Daily). The following drugs were being taken at the same time: NA. When using Zoloft, the patient experienced the following unwanted symptoms/side effects: Interstitial Lung Disease, MalaiseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Interstitial Lung Disease, may become evident only after a product is in use by the general population.
Zoloft Side Effect Report#9947235
Sinusitis, Productive Cough
This Sinusitis side effect was reported by a health professional from Country Not Specified. A 62-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression,insomnia.The patient was prescribed Zoloft (drug dosage: NA), which was initiated on
Feb 23, 2013. Concurrently used drugs:
  • Trazodone
  • Klonopin
  • Protonix
  • Humira
  • Metformin
.After starting to take Zoloft the consumer reported adverse symptoms, such as: Sinusitis, Productive CoughThese side effects may potentially be related to Zoloft.
Zoloft Side Effect Report#9935400
Depression, Tremor
This is a report of a 43-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: depression,anxiety,hiv infection, who was treated with Zoloft (dosage: 100 Mg, 1x/day, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Depression, Tremor after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zoloft treatment in female patients, resulting in Depression side effect.
Zoloft Side Effect Report#9935312
Ischaemic Stroke
This report suggests a potential Zoloft Ischaemic Stroke side effect(s) that can have serious consequences. A 38-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Zoloft (dosage: 1 Df, Once A Day) starting 2011. After starting Zoloft the patient began experiencing various side effects, including: Ischaemic StrokeAdditional drugs used concurrently:
  • Abilify (1 Df, Once A Day)
The patient was hospitalized. Although Zoloft demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Ischaemic Stroke, may still occur.
Zoloft Side Effect Report#9929440
Somnolence, Abnormal Behaviour, Irritability
This Somnolence problem was reported by a consumer or non-health professional from US. A 77-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On NS this consumer started treatment with Zoloft (dosage: 100 Mg, 1x/day). The following drugs were being taken at the same time:
  • Centrum (Unk)
When using Zoloft, the patient experienced the following unwanted symptoms/side effects: Somnolence, Abnormal Behaviour, IrritabilityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Somnolence, may become evident only after a product is in use by the general population.
Zoloft Side Effect Report#9928573
Fall, Foot Fracture
This Fall side effect was reported by a consumer or non-health professional from AR. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression.The patient was prescribed Zoloft (drug dosage: 50 Mg, 1x/day), which was initiated on
Dec 21, 2013. Concurrently used drugs:
  • Mirtazapine (0.25 Df, 1x/day (at Night))
.After starting to take Zoloft the consumer reported adverse symptoms, such as: Fall, Foot FractureThese side effects may potentially be related to Zoloft.
Zoloft Side Effect Report#9925937
Extrasystoles, Bradycardia, Dizziness
This is a report of a 46-year-old female patient (weight: NA) from CN, suffering from the following health symptoms/conditions: anxiety, who was treated with Zoloft (dosage: Unk, start time: 2009), combined with: NA. and developed a serious reaction and side effect(s): Extrasystoles, Bradycardia, Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zoloft treatment in female patients, resulting in Extrasystoles side effect.
Zoloft Side Effect Report#9925931
Skin Necrosis, Dermatitis Exfoliative
This report suggests a potential Zoloft Skin Necrosis side effect(s) that can have serious consequences. A 23-year-old female patient (weight: NA) from CN was diagnosed with the following symptoms/conditions: NA and used Zoloft (dosage: Unk) starting NS. After starting Zoloft the patient began experiencing various side effects, including: Skin Necrosis, Dermatitis ExfoliativeAdditional drugs used concurrently: NA.The patient was hospitalized. Although Zoloft demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Skin Necrosis, may still occur.
Zoloft Side Effect Report#9925591
This Death problem was reported by a consumer or non-health professional from PE. A 79-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Zoloft (dosage: Unk). The following drugs were being taken at the same time: NA. When using Zoloft, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Zoloft Side Effect Report#9925265
Hypersensitivity
This Hypersensitivity side effect was reported by a health professional from US. A 34-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Zoloft (drug dosage: NA), which was initiated on
Dec 30, 2013. Concurrently used drugs:
  • Prilosec
  • Isovue 300
.After starting to take Zoloft the consumer reported adverse symptoms, such as: HypersensitivityThese side effects may potentially be related to Zoloft.
Zoloft Side Effect Report#9919815
Sleep Disorder
This is a report of a 60-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: depression,gastrooesophageal reflux disease,hypertension, who was treated with Zoloft (dosage: Unk, start time: NS), combined with:
  • Pantoprazole (40 Mg, 1x/day)
  • Lisinopril (2.5 Mg, 1x/day)
and developed a serious reaction and side effect(s): Sleep Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zoloft treatment in female patients, resulting in Sleep Disorder side effect.
Zoloft Side Effect Report#9919093
Hypersensitivity
This report suggests a potential Zoloft Hypersensitivity side effect(s) that can have serious consequences. A 41-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Zoloft (dosage: Unk) starting NS. After starting Zoloft the patient began experiencing various side effects, including: HypersensitivityAdditional drugs used concurrently: NA. Although Zoloft demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypersensitivity, may still occur.
Zoloft Side Effect Report#9918879
Suicidal Ideation, Blood Cholesterol Increased
This Suicidal Ideation problem was reported by a consumer or non-health professional from US. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On NS this consumer started treatment with Zoloft (dosage: 25 Mg, Unk). The following drugs were being taken at the same time: NA. When using Zoloft, the patient experienced the following unwanted symptoms/side effects: Suicidal Ideation, Blood Cholesterol IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Suicidal Ideation, may become evident only after a product is in use by the general population.
Zoloft Side Effect Report#9917210
Hyperhidrosis, Pyrexia, Nystagmus, Hallucination, Depressive Symptom, Muscle Rigidity, Muscle Spasms, Delirium, Dysarthria
This Hyperhidrosis side effect was reported by a physician from NO. A 14-year-old male patient (weight:NA) experienced the following symptoms/conditions: depression.The patient was prescribed Zoloft (drug dosage: 25 Mg Daily), which was initiated on 2014. Concurrently used drugs: NA..After starting to take Zoloft the consumer reported adverse symptoms, such as: Hyperhidrosis, Pyrexia, Nystagmus, Hallucination, Depressive Symptom, Muscle Rigidity, Muscle Spasms, Delirium, DysarthriaThese side effects may potentially be related to Zoloft. The patient was hospitalized.
Zoloft Side Effect Report#9916721
Hyponatraemia, Fall, Cardiac Failure, Oedema Peripheral
This is a report of a 92-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Zoloft (dosage: 50 Mg, Unk, start time:
Feb 03, 2014), combined with: NA. and developed a serious reaction and side effect(s): Hyponatraemia, Fall, Cardiac Failure, Oedema Peripheral after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zoloft treatment in female patients, resulting in Hyponatraemia side effect. The patient was hospitalized.
Zoloft Side Effect Report#9914899
Feeling Abnormal, Dizziness, Vomiting
This report suggests a potential Zoloft Feeling Abnormal side effect(s) that can have serious consequences. A 76-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: depression,osteoarthritis and used Zoloft (dosage: Unk) starting 2013. After starting Zoloft the patient began experiencing various side effects, including: Feeling Abnormal, Dizziness, VomitingAdditional drugs used concurrently:
  • Celebrex (200 Mg, Daily)
Although Zoloft demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Feeling Abnormal, may still occur.
Zoloft Side Effect Report#9914467
Confusional State, Disorientation, Feeling Abnormal, Decreased Appetite, Mydriasis
This Confusional State problem was reported by a consumer or non-health professional from US. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: premenstrual dysphoric disorder. On
Jan 09, 2014 this consumer started treatment with Zoloft (dosage: NA). The following drugs were being taken at the same time: NA. When using Zoloft, the patient experienced the following unwanted symptoms/side effects: Confusional State, Disorientation, Feeling Abnormal, Decreased Appetite, MydriasisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Confusional State, may become evident only after a product is in use by the general population.
Zoloft Side Effect Report#9909583
Blood Cholesterol Increased, Blood Homocysteine Increased
This Blood Cholesterol Increased side effect was reported by a consumer or non-health professional from NO. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression,anxiety.The patient was prescribed Zoloft (drug dosage: 200 Ug, Unk), which was initiated on 200605. Concurrently used drugs: NA..After starting to take Zoloft the consumer reported adverse symptoms, such as: Blood Cholesterol Increased, Blood Homocysteine IncreasedThese side effects may potentially be related to Zoloft.
Zoloft Side Effect Report#9908749
Suicidal Ideation, Depression
This is a report of a 54-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: depression,bipolar disorder, who was treated with Zoloft (dosage: 50 Mg, One Q Am, start time:
May 07, 2013), combined with: NA. and developed a serious reaction and side effect(s): Suicidal Ideation, Depression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zoloft treatment in male patients, resulting in Suicidal Ideation side effect.
Zoloft Side Effect Report#9904786
Renal Failure Acute, Glomerulonephritis, Delirium, Pancytopenia, Hyponatraemia
This report suggests a potential Zoloft Renal Failure Acute side effect(s) that can have serious consequences. A 43-year-old female patient (weight: NA) from AU was diagnosed with the following symptoms/conditions: NA and used Zoloft (dosage: 50 Mg, Daily) starting 199507. After starting Zoloft the patient began experiencing various side effects, including: Renal Failure Acute, Glomerulonephritis, Delirium, Pancytopenia, HyponatraemiaAdditional drugs used concurrently:
  • Paracetamol (Unk, As Needed)
  • Carbamazepine (200 Mg, Daily)
Although Zoloft demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Zoloft Side Effect Report#9901377
Renal Failure Acute, Glomerulonephritis, Delirium, Pancytopenia, Hyponatraemia
This Renal Failure Acute problem was reported by a physician from AU. A 43-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 199507 this consumer started treatment with Zoloft (dosage: 50 Mg, Daily). The following drugs were being taken at the same time:
  • Paracetamol (Unk, As Needed)
  • Carbamazepine (200 Mg, Daily)
When using Zoloft, the patient experienced the following unwanted symptoms/side effects: Renal Failure Acute, Glomerulonephritis, Delirium, Pancytopenia, HyponatraemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Failure Acute, may become evident only after a product is in use by the general population.
Zoloft Side Effect Report#9897994
Blood Pressure Abnormal, Serotonin Syndrome, Off Label Use
This Blood Pressure Abnormal side effect was reported by a consumer or non-health professional from US. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: nervous system disorder,blood disorder.The patient was prescribed Zoloft (drug dosage: Unk), which was initiated on 201309. Concurrently used drugs:
  • Jantoven (3 Mg, 1x/day)
.After starting to take Zoloft the consumer reported adverse symptoms, such as: Blood Pressure Abnormal, Serotonin Syndrome, Off Label UseThese side effects may potentially be related to Zoloft. The patient was hospitalized.
Zoloft Side Effect Report#9893686
Toxicity To Various Agents, Abdominal Pain Upper
This is a report of a 14-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Zoloft (dosage: Prescribed On Packet, start time:
Nov 04, 2013), combined with: NA. and developed a serious reaction and side effect(s): Toxicity To Various Agents, Abdominal Pain Upper after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zoloft treatment in female patients, resulting in Toxicity To Various Agents side effect.


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The appearance of Zoloft on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Zoloft Side Effects for Women?

Women Side Effects Reports
Anxiety 396
Depression 370
Nausea 240
Feeling Abnormal 235
Insomnia 227
Dizziness 217
Headache 210
Atrial Septal Defect 187
Fatigue 184
Diarrhoea 161

What are common Zoloft Side Effects for Men?

Men Side Effects Reports
Atrial Septal Defect 154
Anxiety 150
Depression 136
Insomnia 103
Dizziness 101
Developmental Delay 95
Feeling Abnormal 94
Patent Ductus Arteriosus 85
Completed Suicide 83
Maternal Exposure During Pregnancy 81

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Zoloft reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Zoloft Safety Alerts, Active Ingredients, Usage Information

    NDC 0049-4900
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Zoloft
    Name sertraline hydrochloride
    Dosage Form TABLET, FILM COATED
    Route ORAL
    On market since 19920211
    Labeler Roerig
    Active Ingredient(s) SERTRALINE HYDROCHLORIDE
    Strength(s) 50
    Unit(s) mg/1
    Pharma Class Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

    Zoloft Dosage, Warnings, Usage.

    Side Effects reported to FDA: 6792

    Zoloft safety alerts: 2005 2002

    Reported deaths: 627

    Reported hospitalizations: 2227

    Zoloft (sertraline)

    Audience: Neuropsychiatric healthcare professionals and consumers

    [UPDATE 07/08/2005] FDA notified healthcare professionals about the availability of updated Healthcare Professional and Patient Information Sheets for antidepressant medications that were the subject of a June 30, 2005 Public Health Advisory issued about the risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications.

    [Posted 07/01/2005] In response to recent scientific publications that report the possibility of increased risk of suicidal behavior in adults treated with antidepressants, the FDA has issued a Public Health Advisory to update patients and healthcare providers with the latest information on this subject. Even before the publication of these recent reports, FDA had already begun the process of reviewing available data to determine whether there is an increased risk of suicidal behavior in adults taking antidepressants. The Agency has asked manufacturers to provide information from their trials using an approach similar to that used in the evaluation of the risk of suicidal behavior in the pediatric population taking antidepressants. This effort will involve hundreds of clinical trials and may take more than a year to complete.

    [July 08, 2005 - Healthcare Professional and Patient Information Sheets - FDA]
    [June 30, 2005 - Public Health Advisory - FDA]
    [June 30, 2005 - Drug Information Page - FDA]

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