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Zoloft (Sertraline Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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
Percentage of Patients Reporting Event
Major Depressive Disorder/Other 1 OCDPanic DisorderPTSD
Body System/Adverse EventZOLOFT
(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 Failure 2 7<1172191111
  Mouth Dry1691491510116
  Sweating Increased83615142
Center. & Periph. Nerv. System Disorders
  Somnolence136158159139
  Tremor11 3815151
  Dizziness127179101085
General
  Fatigue1181410116105
  Pain12313346
  Malaise<11117141010
Gastrointestinal Disorders
  Abdominal Pain22556765
  Anorexia3 21127282
  Constipation8 6647333
  Diarrhea/Loose Stools18924102092415
  Dyspepsia6310410866
  Nausea2612301129182111
Psychiatric Disorders
  Agitation64636255
  Insomnia169281225182011
  Libido Decreased1<11127172
PMDD
Daily Dosing
PMDD
Luteal Phase Dosing
The 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.
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 FailureN/AN/AN/AN/A14-
  Mouth Dry63103124
  Sweating Increased6<130112
Center. & Periph. Nerv. System Disorders
  Somnolence7<12096
  Tremor20<1<193
  Dizziness6375146
General
  Fatigue16710<1126
  Pain6<13213
  Malaise957583
Gastrointestinal Disorders
  Abdominal Pain7<13355
  Anorexia325063
  Constipation231253
  Diarrhea/Loose Stools133137218
  Dyspepsia7273135
  Nausea239133228
Psychiatric Disorders
  Agitation2<11042
  Insomnia171112102510
  Libido Decreased1124293

1 Major depressive disorder and other premarketing controlled trials.
2 Primarily 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).

TABLE 3 TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Percentage of Patients Reporting Event Major Depressive Disorder/OtherMajor depressive disorder and other premarketing controlled trials., OCD, Panic Disorder, PTSD, PMDD and Social Anxiety Disorder combined
Body System/Adverse EventIncluded 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.ZOLOFT
(N=2799)
Placebo
(N=2394)
 
Autonomic Nervous System Disorders
  Ejaculation FailurePrimarily ejaculatory delay. Denominator used was for male patients only (N=1118 ZOLOFT; N=926 placebo).141
  Mouth Dry148
  Sweating Increased72
Center. & Periph. Nerv. System Disorders
  Somnolence137
  Dizziness127
  Headache2523
  Paresthesia21
  Tremor82
Disorders of Skin and Appendages
  Rash32
Gastrointestinal Disorders
  Anorexia62
  Constipation64
  Diarrhea/Loose Stools2010
  Dyspepsia84
  Nausea2511
  Vomiting42
General
  Fatigue127
Psychiatric Disorders
  Agitation53
  Anxiety43
  Insomnia2111
  Libido Decreased62
  Nervousness54
Special Senses
  Vision Abnormal32

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 EventMajor Depressive Disorder/Other 1, 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 Pain1%
Agitation1%2%
Anxiety2%
Diarrhea/ Loose Stools2%2%2%1%2%
Dizziness1%
Dry Mouth1%
Dyspepsia1%
Ejaculation FailurePrimarily 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).1%1%1%2%N/AN/A2%
Fatigue2%
Headache1%2%1%2%
Hot Flushes1%
Insomnia2%1%3%2%1%3%
Nausea3%4%3%3%2%2%1%2%
Nervousness2%
Palpitation1%
Somnolence1%1%2%2%
Tremor2%

1 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 EventZOLOFTPlacebo
Ejaculation failureDenominator used was for male patients only (N=1118 ZOLOFT; N=926 placebo)
(primarily delayed ejaculation)
14%1%
Decreased libidoDenominator used was for male and female patients (N=2799 ZOLOFT; N=2394 placebo)6%1%

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, 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-type arrhythmias), hypothyroidism, agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness, 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.



REPORTS OF SUSPECTED ZOLOFT SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Zoloft. The information is not vetted and should not be considered as verified clinical evidence.

Possible Zoloft side effects / adverse reactions in 62 year old male

Reported by a physician from Japan on 2011-10-04

Patient: 62 year old male weighing 70.0 kg (154.0 pounds)

Reactions: Cerebral Haemorrhage

Adverse event resulted in: hospitalization

Suspect drug(s):
Tolterodine Tartrate
    Dosage: 4 mg, 1x/day
    Administration route: Oral
    Indication: Hypertonic Bladder
    Start date: 2010-11-19
    End date: 2011-03-26

Magnesium Sulfate
    Dosage: 330 mg, 2x/day
    Administration route: Oral
    Indication: Constipation
    Start date: 2008-09-01
    End date: 2011-03-27

Pregabalin
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2010-10-25
    End date: 2011-03-27

Brotizolam
    Dosage: 0.25 mg, 1x/day
    Administration route: Oral
    Indication: Insomnia
    Start date: 2009-05-13
    End date: 2011-03-27

Livostin
    Dosage: 3 or 4 times daily
    Indication: Conjunctivitis Allergic
    Start date: 2010-10-01
    End date: 2011-03-27

Betamethasone
    Dosage: unk
    Start date: 2011-03-02
    End date: 2011-03-27

Amlodipine Besylate
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-10-29
    End date: 2011-03-27

Zoloft
    Dosage: 25 mg, 2x/day
    Administration route: Oral
    Indication: Depression
    Start date: 2008-06-26
    End date: 2011-03-27

Isosorbide Dinitrate
    Dosage: 20 mg, 2x/day
    Administration route: Oral
    Indication: Angina Pectoris
    Start date: 2008-05-22
    End date: 2011-03-27

Cyanocobalamin
    Dosage: 3 or 4 times daily
    Indication: Asthenopia
    Start date: 2010-10-01
    End date: 2011-03-27

Allegra D 24 Hour
    Dosage: 60 mg, 2x/day
    Administration route: Oral
    Indication: Pustular Psoriasis
    Start date: 2011-03-02
    End date: 2011-03-27

Ketoprofen
    Dosage: unk
    Indication: Back Pain
    Start date: 2008-06-01
    End date: 2011-03-27

Olmesartan Medoxomil
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-05-01
    End date: 2011-03-27

Betamethasone
    Dosage: unk
    Indication: Pustular Psoriasis
    Start date: 2008-10-24
    End date: 2011-03-27

Phenobarbital TAB
    Dosage: 30 mg, 3x/day
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2008-01-01
    End date: 2011-03-27

Loxoprofen Sodium
    Dosage: 60 mg, as needed
    Administration route: Oral
    Indication: Pain
    Start date: 2009-05-07
    End date: 2011-03-27



Possible Zoloft side effects / adverse reactions in 14 year old female

Reported by a physician from Italy on 2011-10-04

Patient: 14 year old female

Reactions: Conjunctival Haemorrhage, Headache, Periorbital Haematoma

Adverse event resulted in: hospitalization

Suspect drug(s):
Zoloft

Other drugs received by patient: Zyprexa



Possible Zoloft side effects / adverse reactions in 68 year old female

Reported by a physician from Japan on 2011-10-04

Patient: 68 year old female weighing 38.0 kg (83.6 pounds)

Reactions: Serotonin Syndrome, Pyrexia, Liver Disorder, Inflammation

Adverse event resulted in: hospitalization

Suspect drug(s):
Tetramide
    Dosage: 10 mg, 2x/day
    Administration route: Oral
    Indication: Depression
    Start date: 2011-07-26
    End date: 2011-08-19

Zoloft
    Dosage: 25 mg daily
    Administration route: Oral
    Indication: Depression
    Start date: 2011-08-08
    End date: 2011-08-19



See index of all Zoloft side effect reports >>

Drug label data at the top of this Page last updated: 2008-12-17

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