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Zoloft

Zoloft

Zoloft Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Zoloft (sertraline) is a medication that belongs to the drug class SSRIs (selective serotonin reuptake inhibitors). Zoloft is available as a generic drug, and is prescribed for the treatment of depression, obsessive compulsive disorder (OCD), panic disorder, posttraumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder (PMDD). Common side effects of Zoloft include sleepiness, nervousness, insomnia, dizziness, nausea, skin rash, headache, diarrhea, upset stomach, loss of appetite, abnormal ejaculation, dry mouth, and weight loss.

Zoloft dosage depends on the condition being treated. Drug interactions and warnings include interactions with MAOIs (monoamine oxidase inhibitors) antidepressant drugs, Tagamet (cimetidine), Orap (pimozide), and Coumadin (warfarin). Zoloft use during pregnancy may lead to adverse effects in the newborn. In some patients, if Zoloft is discontinued abruptly, withdrawal side effects include abdominal cramps, flu-like symptoms, fatigue, and memory impairment.

Our Zoloft Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zoloft in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • agitation, hallucinations, fever, overactive reflexes, tremors;
  • nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or
  • headache, trouble concentrating, memory problems, weakness, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

  • drowsiness, dizziness, tired feeling;
  • mild nausea, stomach pain, upset stomach, constipation;
  • dry mouth;
  • changes in appetite or weight;
  • sleep problems (insomnia); or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zoloft (Sertraline Hcl) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Zoloft Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, dizziness, drowsiness, dry mouth, loss of appetite, increased sweating, diarrhea, upset stomach, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: easy bruising/bleeding, decreased interest in sex, decrease in sexual ability (ejaculation delay), muscle cramps/weakness, shaking (tremor), unusual weight loss.

Get medical help right away if any of these rare but serious side effects occur: black/bloody stools, vomit that looks like coffee grounds.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Zoloft (Sertraline Hcl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zoloft FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

During its premarketing assessment, multiple doses of ZOLOFT were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to ZOLOFT varied greatly, and included (in overlapping categories) clinical pharmacology studies, open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and studies for multiple indications, including major depressive disorder, OCD, panic disorder, PTSD, PMDD and social anxiety disorder.

Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.

In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of ZOLOFT who experienced a treatment-emergent adverse event of the type cited on at least one occasion while receiving ZOLOFT. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that events reported during therapy were not necessarily caused by it.

The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the side effect incidence rate in the population studied.

Incidence in Placebo-Controlled Trials

Table 2 enumerates the most common treatment-emergent adverse events associated with the use of ZOLOFT (incidence of at least 5% for ZOLOFT and at least twice that for placebo within at least one of the indications) for the treatment of adult patients with major depressive disorder/other*, OCD, panic disorder, PTSD, PMDD and social anxiety disorder in placebo-controlled clinical trials. Most patients in major depressive disorder/other*, OCD, panic disorder, PTSD and social anxiety disorder studies received doses of 50 to 200 mg/day. Patients in the PMDD study with daily dosing throughout the menstrual cycle received doses of 50 to 150 mg/day, and in the PMDD study with dosing during the luteal phase of the menstrual cycle received doses of 50 to 100 mg/day. Table 3 enumerates treatment-emergent adverse events that occurred in 2% or more of adult patients treated with ZOLOFT and with incidence greater than placebo who participated in controlled clinical trials comparing ZOLOFT with placebo in the treatment of major depressive disorder/other*, OCD, panic disorder, PTSD, PMDD and social anxiety disorder. Table 3 provides combined data for the pool of studies that are provided separately by indication in Table 2.

TABLE 2 : MOST COMMON TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS

Body System/Adverse Event Percentage of Patients Reporting Event
Major Depressive Disorder/Other* OCD Panic Disorder PTSD
ZOLOFT
(N=861)
Placebo
(N=853)
ZOLOFT
(N=533)
Placebo
(N=373)
ZOLOFT
(N=430)
Placebo
(N=275)
ZOLOFT
(N=374)
Placebo
(N=376)
Autonomic Nervous System Disorders
  Ejaculation Failure1 7 < 1 17 2 19 1 11 1
  Mouth Dry 16 9 14 9 15 10 11 6
  Sweating Increased 8 3 6 1 5 1 4 2
Center. & Periph. Nerv. System Disorders
  Somnolence 13 6 15 8 15 9 13 9
  Tremor 11 3 8 1 5 1 5 1
  Dizziness 12 7 17 9 10 10 8 5
General
  Fatigue 11 8 14 10 11 6 10 5
  Pain 1 2 3 1 3 3 4 6
  Malaise < 1 1 1 1 7 14 10 10
Gastrointestinal Disorders
  Abdominal Pain 2 2 5 5 6 7 6 5
  Anorexia 3 2 11 2 7 2 8 2
  Constipation 8 6 6 4 7 3 3 3
  Diarrhea/Loose Stools 18 9 24 10 20 9 24 15
  Dyspepsia 6 3 10 4 10 8 6 6
  Nausea 26 12 30 11 29 18 21 11
Psychiatric Disorders
  Agitation 6 4 6 3 6 2 5 5
  Insomnia 16 9 28 12 25 18 20 11
  Libido Decreased 1 < 1 11 2 7 1 7 2
  PMDD Daily Dosing PMDD Luteal Phase Dosing2 Social Anxiety Disorder  
Body System/Adverse Event ZOLOFT
(N=121)
Placebo
(N=122)
ZOLOFT
(N=136)
Placebo
(N=127)
ZOLOFT
(N=344)
Placebo
(N=268)
   
Autonomic Nervous System Disorders    
  Ejaculation Failure1 N/A N/A N/A N/A 14 -    
  Mouth Dry 6 3 10 3 12 4    
  Sweating Increased 6 < 1 3 0 11 2    
Center. & Periph. Nerv. System Disorders    
  Somnolence 7 < 1 2 0 9 6    
  Tremor 2 0 < 1 < 1 9 3    
  Dizziness 6 3 7 5 14 6    
General    
  Fatigue 16 7 10 < 1 12 6    
  Pain 6 < 1 3 2 1 3    
  Malaise 9 5 7 5 8 3    
Gastrointestinal Disorders    
  Abdominal Pain 7 < 1 3 3 5 5    
  Anorexia 3 2 5 0 6 3    
  Constipation 2 3 1 2 5 3    
  Diarrhea/Loose Stools 13 3 13 7 21 8    
  Dyspepsia 7 2 7 3 13 5    
  Nausea 23 9 13 3 22 8    
Psychiatric Disorders    
  Agitation 2 < 1 1 0 4 2    
  Insomnia 17 11 12 10 25 10    
  Libido Decreased 11 2 4 2 9 3    
1Primarily ejaculatory delay. Denominator used was for male patients only (N=271 ZOLOFT major depressive disorder/other*; N=271 placebo major depressive disorder/other*; N=296 ZOLOFT OCD; N=219 placebo OCD; N=216 ZOLOFT panic disorder; N=134 placebo panic disorder; N=130 ZOLOFT PTSD; N=149 placebo PTSD; No male patients in PMDD studies; N=205 ZOLOFT social anxiety disorder; N=153 placebo social anxiety disorder). *Major depressive disorder and other premarketing controlled trials.
2The luteal phase and daily dosing PMDD trials were not designed for making direct comparisons between the two dosing regimens. Therefore, a comparison between the two dosing regimens of the PMDD trials of incidence rates shown in Table 2 should be avoided.

TABLE 3 : TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Percentage of Patients Reporting Event Major Depressive Disorder/Other*, OCD, Panic Disorder, PTSD, PMDD and Social Anxiety Disorder combined

Body System/Adverse Event** ZOLOFT
(N=2799)
Placebo
(N=2394)
Autonomic Nervous System Disorders
  Ejaculation Failure1 14 1
  Mouth Dry 14 8
  Sweating Increased 7 2
Center. & Periph. Nerv. System Disorders
  Somnolence 13 7
  Dizziness 12 7
  Headache 25 23
  Paresthesia 2 1
  Tremor 8 2
Disorders of Skin and Appendages
  Rash 3 2
Gastrointestinal Disorders
  Anorexia 6 2
  Constipation 6 4
  Diarrhea/Loose Stools 20 10
  Dyspepsia 8 4
  Nausea 25 11
  Vomiting 4 2
General
  Fatigue 12 7
Psychiatric Disorders
  Agitation 5 3
  Anxiety 4 3
  Insomnia 21 11
  Libido Decreased 6 2
  Nervousness 5 4
Special Senses
  Vision Abnormal 3 2
1Primarily ejaculatory delay. Denominator used was for male patients only (N=1118 ZOLOFT; N=926 placebo).
*Major depressive disorder and other premarketing controlled trials.
**Included are events reported by at least 2% of patients taking ZOLOFT except the following events, which had an incidence on placebo greater than or equal to ZOLOFT: abdominal pain, back pain, flatulence, malaise, pain, pharyngitis, respiratory disorder, upper respiratory tract infection.

Associated With Discontinuation In Placebo-Controlled Clinical Trials

Table 4 lists the adverse events associated with discontinuation of ZOLOFT (sertraline hydrochloride) treatment (incidence at least twice that for placebo and at least 1% for ZOLOFT in clinical trials) in major depressive disorder/other*, OCD, panic disorder, PTSD, PMDD and social anxiety disorder.

TABLE 4 : MOST COMMON ADVERSE EVENTS ASSOCIATED WITH DISCONTINUATION IN PLACEBO-CONTROLLED CLINICAL TRIALS

Adverse Event Major Depressive Disorder/Other*, OCD, Panic Disorder, PTSD, PMDD and Social Anxiety Disorder combined
(N=2799)
Major Depressive Disorder/ Other*
(N=861)
OCD
(N=533)
Panic Disorder
(N=430)
PTSD
(N=374)
PMDD Daily Dosing
(N=121)
PMDD Luteal Phase Dosing
(N=136)
Social Anxiety Disorder
(N=344)
Abdominal Pain - - - - - - - 1%
Agitation - 1% - 2% - - - -
Anxiety - - - - - - - 2%
Diarrhea/ Loose Stools 2% 2% 2% 1% - 2% - -
Dizziness - - 1% - - - - -
Dry Mouth - 1% - - - - - -
Dyspepsia - - - 1% - - - -
Ejaculation Failure1 1% 1% 1% 2% - N/A N/A 2%
Fatigue - - - - - - - 2%
Headache 1% 2% - - 1% - - 2%
Hot Flushes - - - - - - 1% -
Insomnia 2% 1% 3% 2% - - 1% 3%
Nausea 3% 4% 3% 3% 2% 2% 1% 2%
Nervousness - - - - - 2% - -
Palpitation - - - - - - 1% -
Somnolence 1% 1% 2% 2% - - - -
Tremor - 2% - - - - - -
1Primarily ejaculatory delay. Denominator used was for male patients only (N=271 major depressive disorder/other*; N=296 OCD; N=216 panic disorder; N=130 PTSD; No male patients in PMDD studies; N=205 social anxiety disorder).
*Major depressive disorder and other premarketing controlled trials.

Male And Female Sexual Dysfunction With SSRIs

Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence.

Table 5 below displays the incidence of sexual side effects reported by at least 2% of patients taking ZOLOFT in placebo-controlled trials.

Table 5

Adverse Event ZOLOFT Placebo
Ejaculation failure* (primarily delayed ejaculation) 14% 1%
Decreased libido** 6% 1%
*Denominator used was for male patients only (N=1118 ZOLOFT; N=926 placebo)
**Denominator used was for male and female patients (N=2799 ZOLOFT; N=2394 placebo)

There are no adequate and well-controlled studies examining sexual dysfunction with sertraline treatment.

Priapism has been reported with all SSRIs.

While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.

Other Adverse Events in Pediatric Patients

In over 600 pediatric patients treated with ZOLOFT, the overall profile of adverse events was generally similar to that seen in adult studies. However, the following adverse events, from controlled trials, not appearing in Tables 2 and 3, were reported at an incidence of at least 2% and occurred at a rate of at least twice the placebo rate (N=281 patients treated with ZOLOFT): fever, hyperkinesia, urinary incontinence, aggressive reaction, sinusitis, epistaxis and purpura.

Other Events Observed During the Premarketing Evaluation of ZOLOFT (sertraline hydrochloride)

Following is a list of treatment-emergent adverse events reported during premarketing assessment of ZOLOFT in clinical trials (over 4000 adult subjects) except those already listed in the previous tables or elsewhere in labeling.

In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of ZOLOFT who experienced an event of the type cited on at least one occasion while receiving ZOLOFT. All events are included except those already listed in the previous tables or elsewhere in labeling and those reported in terms so general as to be uninformative and those for which a causal relationship to ZOLOFT treatment seemed remote. It is important to emphasize that although the events reported occurred during treatment with ZOLOFT, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; Rare events are those occurring in fewer than 1/1000 patients. Events of major clinical importance are also described in the PRECAUTIONS section.

Autonomic Nervous System Disorders-Frequent: impotence; Infrequent: flushing, increased saliva, cold clammy skin, mydriasis; Rare: pallor, angle-closure glaucoma, priapism, vasodilation.

Body as a Whole-General Disorders-Rare: allergic reaction, allergy.

Cardiovascular-Frequent: palpitations, chest pain; Infrequent: hypertension, tachycardia, postural dizziness, postural hypotension, periorbital edema, peripheral edema, hypotension, peripheral ischemia, syncope, edema, dependent edema; Rare: precordial chest pain, substernal chest pain, aggravated hypertension, myocardial infarction, cerebrovascular disorder.

Central and Peripheral Nervous System Disorders-Frequent: hypertonia, hypoesthesia; Infrequent: twitching, confusion, hyperkinesia, vertigo, ataxia, migraine, abnormal coordination, hyperesthesia, leg cramps, abnormal gait, nystagmus, hypokinesia; Rare: dysphonia, coma, dyskinesia, hypotonia, ptosis, choreoathetosis, hyporeflexia.

Disorders of Skin and Appendages-Infrequent: pruritus, acne, urticaria, alopecia, dry skin, erythematous rash, photosensitivity reaction, maculopapular rash; Rare: follicular rash, eczema, dermatitis, contact dermatitis, bullous eruption, hypertrichosis, skin discoloration, pustular rash.

Endocrine Disorders-Rare: exophthalmos, gynecomastia.

Gastrointestinal Disorders-Frequent: appetite increased; Infrequent: dysphagia, tooth caries aggravated, eructation, esophagitis, gastroenteritis; Rare: melena, glossitis, gum hyperplasia, hiccup, stomatitis, tenesmus, colitis, diverticulitis, fecal incontinence, gastritis, rectum hemorrhage, hemorrhagic peptic ulcer, proctitis, ulcerative stomatitis, tongue edema, tongue ulceration.

General-Frequent: back pain, asthenia, malaise, weight increase; Infrequent: fever, rigors, generalized edema; Rare: face edema, aphthous stomatitis.

Hearing and Vestibular Disorders-Rare: hyperacusis, labyrinthine disorder.

Hematopoietic and Lymphatic-Rare: anemia, anterior chamber eye hemorrhage.

Liver and Biliary System Disorders-Rare: abnormal hepatic function.

Metabolic and Nutritional Disorders-Infrequent: thirst; Rare: hypoglycemia, hypoglycemia reaction.

Musculoskeletal System Disorders-Frequent: myalgia; Infrequent: arthralgia, dystonia, arthrosis, muscle cramps, muscle weakness.

Psychiatric Disorders-Frequent: yawning, other male sexual dysfunction, other female sexual dysfunction; Infrequent: depression, amnesia, paroniria, teeth-grinding, emotional lability, apathy, abnormal dreams, euphoria, paranoid reaction, hallucination, aggressive reaction, aggravated depression, delusions; Rare: withdrawal syndrome, suicide ideation, libido increased, somnambulism, illusion.

Reproductive-Infrequent: menstrual disorder, dysmenorrhea, intermenstrual bleeding, vaginal hemorrhage, amenorrhea, leukorrhea; Rare: female breast pain, menorrhagia, balanoposthitis, breast enlargement, atrophic vaginitis, acute female mastitis.

Respiratory System Disorders-Frequent: rhinitis; Infrequent: coughing, dyspnea, upper respiratory tract infection, epistaxis, bronchospasm, sinusitis; Rare: hyperventilation, bradypnea, stridor, apnea, bronchitis, hemoptysis, hypoventilation, laryngismus, laryngitis.

Special Senses-Frequent: tinnitus; Infrequent: conjunctivitis, earache, eye pain, abnormal accommodation; Rare: xerophthalmia, photophobia, diplopia, abnormal lacrimation, scotoma, visual field defect.

Urinary System Disorders-Infrequent: micturition frequency, polyuria, urinary retention, dysuria, nocturia, urinary incontinence; Rare: cystitis, oliguria, pyelonephritis, hematuria, renal pain, strangury.

Laboratory Tests-In man, asymptomatic elevations in serum transaminases (SGOT [or AST] and SGPT [or ALT]) have been reported infrequently (approximately 0.8%) in association with ZOLOFT (sertraline hydrochloride) administration. These hepatic enzyme elevations usually occurred within the first 1 to 9 weeks of drug treatment and promptly diminished upon drug discontinuation.

ZOLOFT therapy was associated with small mean increases in total cholesterol (approximately 3%) and triglycerides (approximately 5%), and a small mean decrease in serum uric acid (approximately 7%) of no apparent clinical importance.

The safety profile observed with ZOLOFT treatment in patients with major depressive disorder, OCD, panic disorder, PTSD, PMDD and social anxiety disorder is similar.

Other Events Observed During the Post marketing Evaluation of ZOLOFT

Reports of adverse events temporally associated with ZOLOFT that have been received since market introduction, that are not listed above and that may have no causal relationship with the drug, include the following: acute renal failure, anaphylactoid reaction, angioedema, blindness, optic neuritis, cataract, increased coagulation times, bradycardia, AV block, atrial arrhythmias, QT-interval prolongation, ventricular tachycardia (including Torsade de Pointes arrhythmias), cerebrovascular spasm (including reversible cerebral vasconstriction syndrome and Call-Fleming syndrome), hypothyroidism, agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness, diabetes mellitus, hyperglycemia, galactorrhea, hyperprolactinemia, extrapyramidal symptoms, oculogyric crisis, serotonin syndrome, psychosis, pulmonary hypertension, severe skin reactions, which potentially can be fatal, such as Stevens-Johnson syndrome, vasculitis, photosensitivity and other severe cutaneous disorders, Rare reports of pancreatitis, and liver events-clinical features (which in the majority of cases appeared to be reversible with discontinuation of ZOLOFT) occurring in one or more patients include: elevated enzymes, increased bilirubin, hepatomegaly, hepatitis, jaundice, abdominal pain, vomiting, liver failure and death.

Drug Abuse And Dependence

Controlled Substance Class

ZOLOFT (sertraline hydrochloride) is not a controlled substance.

Physical and Psychological Dependence

In a placebo-controlled, double-blind, randomized study of the comparative abuse liability of ZOLOFT, alprazolam, and d-amphetamine in humans, ZOLOFT did not produce the positive subjective effects indicative of abuse potential, such as euphoria or drug liking, that were observed with the other two drugs. Premarketing clinical experience with ZOLOFT did not reveal any tendency for a withdrawal syndrome or any drug-seeking behavior. In animal studies ZOLOFT does not demonstrate stimulant or barbiturate-like (depressant) abuse potential. As with any CNS active drug, however, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of ZOLOFT misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

Read the entire FDA prescribing information for Zoloft (Sertraline Hcl) »

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Zoloft - User Reviews

Zoloft User Reviews

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Here is a collection of user reviews for the medication Zoloft sorted by most helpful. Patient Discussions FAQs

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