Zoloft effects

Adverse Effects

In clinical development programs, sertraline has been evaluated in 1902 subjects with depression. The most commonly observed adverse events associated with the use of sertraline were: gastrointestinal complaints, including nausea, diarrhea/loose stools and dyspepsia; male sexual dysfunction (primarily ejaculatory delay); insomnia and somnolence; tremor; increased sweating and dry mouth; and dizziness. In the fixed dose placebo controlled study, the overall incidence of side effects was dose related with a majority occurring in the patients treated with 200 mg dose.

The discontinuation rate due to adverse events was 15% in 2710 subjects who received sertraline in premarketing multiple dose clinical trials. The more common events (reported by at least 1% of subjects) associated with discontinuation included agitation, insomnia, male sexual dysfunction (primarily ejaculatory delay), somnolence, dizziness, headache, tremor, anorexia, diarrhea/loose stools, nausea and fatigue.

Incidence in Controlled Clinical Trials:
Table II enumerates adverse events that occurred at a frequency of 1% or more among sertraline patients who participated in controlled trials comparing titrated sertraline with placebo.

—————————————————————–
Table II
Treatment-Emergent Adverse Experience Incidence in
Placebo-Controlled Clinical Trials*
—————————————————————–
Percent of Patients Reporting
Zoloft Placebo Difference
Adverse Experience (N=861) (N=853) Percentage
Autonomic Nervous System Disorders
Mouth Dry 16.3 9.3 7.0
Sweating Increased 8.4 2.9 5.5
Cardiovascular
Palpitations 3.5 1.6 1.9
Chest Pain 1.0 1.6 -0.6
Central and Peripheral Nervous System Disorders
Headache 20.3 19.0 1.3
Dizziness 11.7 6.7 5.0
Tremor 10.7 2.7 8.0
Paresthesia 2.0 1.8 0.2
Hypoesthesia 1.7 0.6 1.1
Twitching 1.4 0.1 1.3
Hypertonia 1.3 0.4 0.9
Disorders of Skin and Appendages
Rash 2.1 1.5 0.6
Gastrointestinal Disorders
Nausea 26.1 11.8 14.3
Diarrhea/Loose Stools 17.7 9.3 8.4
Constipation 8.4 6.3 2.1
Dyspepsia 6.0 2.8 3.2
Vomiting 3.8 1.8 2.0
Flatulence 3.3 2.5 0.8
Anorexia 2.8 1.6 1.2
Abdominal Pain 2.4 2.2 0.2
Appetite Increased 1.3 0.9 0.4
General
Fatigue 10.6 8.1 2.5
Hot Flushes 2.2 0.5 1.7
Fever 1.6 0.6 1.0
Back Pain 1.5 0.9 0.6
Metabolic and Nutritional Disorders
Thirst 1.4 0.9 0.5
Musculo-Skeletal System Disorders
Myalgia 1.7 1.5 0.2
Psychiatric Disorders
Insomnia 16.4 8.8 7.6
Sexual Dysfunction-
Male (1) 15.5 2.2 13.3
Somnolence 13.4 5.9 7.5
Agitation 5.6 4.0 1.6
Nervousness 3.4 1.9 1.5
Anxiety 2.6 1.3 1.3
Yawning 1.9 0.2 1.7
Sexual Dysfunction-
Female (2) 1.7 0.2 1.5
Concentration Impaired 1.3 0.5 0.8
Reproduction
Menstrual Disorder (2) 1.0 0.5 0.5
Respiratory System Disorders
Rhinitis 2.0 1.5 0.5
Pharyngitis 1.2 0.9 0.3
pecial Senses
Vision Abnormal 4.2 2.1 2.1
Tinnitus 1.4 1.1 0.3
Taste Perversion 1.2 0.7 0.5
Urinary System Disorders
Micturition Frequency 2.0 1.2 0.8
Micturition Disorder 1.4 0.5 0.9
—————————————————————–
*Events reported by at least 1% of patients treated with
Zoloft are included.
(1)% based on male patients only: 271 Zoloft and 271 placebo
patients. Male sexual dysfunction can be broken down into
the categories of decreased libido, impotence and ejaculatory
delay. In this data set, the percentages of males in the
Zoloft group with these complaints are 4.8%, 4.8% and 8.9%,
respectively. It should be noted that since some Zoloft
patients reported more than one category of male sexual
dysfunction, the incidence of each category of male sexual
dysfunction combined is larger than the incidence for the
general category of male sexual dysfunction, in which each
patient is counted only once.
(2)% based on female patient only: 590 Zoloft and 582 placebo
patients.
—————————————————————–

Zoloft effects

Other events observed during the premarketing evaluation of sertraline:
During its premarketing assessment, multiple doses of sertraline were administered to 2710 subjects. The conditions and duration of exposure to sertraline 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 indications other than depression. 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.

All events are included except those already listed in Table II or in the Precautions section, and those reported in terms so general as to be uninformative. It is important to emphasize that although the events reported occurred during treatment with sertraline, they were not necessarily caused by it.

Autonomic Nervous System Disorders:
Infrequent: Flushing, mydriasis, increased saliva, cold clammy skin. Rare: Pallor.

Cardiovascular:
Infrequent: Postural dizziness, hypertension, hypotension, postural hypotension, edema, dependent edema, periorbital edema, peripheral edema, peripheral ischemia, syncope, tachycardia. Rare: Precordial chest pain, substernal chest pain, aggravated hypertension, myocardial infarction, varicose veins.

Central and Peripheral Nervous System Disorders:
Frequent: Confusion. Infrequent: Ataxia, abnormal coordination, abnormal gait, hyperesthesia, hyperkinesia, hypokinesia, migraine, nystagmus, vertigo. Rare: Local anesthesia, coma, convulsions, dyskinesia, dysphonia, hyporeflexia, hypotonia, ptosis.

Disorders of Skin and Appendages:
Infrequent: Acne, alopecia, pruritus, erythematous rash, maculopapular rash, dry skin. Rare: Bullous eruption, dermatitis, erythema multiforme, abnormal hair texture, hypertrichosis, photosensitivity reaction, follicular rash, skin discoloration, abnormal skin odor, urticaria.

Endocrine Disorders:
Rare: Exophthalmos, gynecomastia.

Gastrointestinal Disorders:
Infrequent: Dysphagia, eructation. Rare: Diverticulitis, fecal incontinence, gastritis, gastroenteritis, glossitis, gum hyperplasia, hemorrhoids, hiccup, melena, hemorrhagic peptic ulcer, proctitis, stomatitis, ulcerative stomatitis, tenesmus, tongue edema, tongue ulceration.

General:
Frequent: Asthenia. Infrequent: Malaise, generalized edema, rigors, weight decrease, weight increase. Rare: Enlarged abdomen, halitosis, otitis media, aphthous stomatitis.

Hematopoietic and Lymphatic:
Infrequent: Lymphadenopathy, purpura. Rare: Anemia, anterior chamber eye hemorrhage.

Metabolic and Nutritional Disorders:
Rare: Dehydration, hypercholesterolemia, hypoglycemia.

Musculo-Skeletal System Disorders:
Infrequent: Arthralgia, arthrosis, dystonia, muscle cramps, muscle weakness. Rare: Hernia.

Psychiatric Disorders:
Infrequent: Abnormal dreams, aggressive reaction, amnesia, apathy, delusion, depersonalization, depression, aggravated depression, emotional lability, euphoria, hallucination, neurosis, paranoid reaction, suicide attempt (including suicidal ideation), teeth-grinding, abnormal thinking. Rare: Hysteria, somnambulism withdrawal syndrome.

Reproductive:
Infrequent: Dysmenorrhea (2), intermenstrual bleeding (2). Rare: Amenorrhea (2), balanoposthitis (1), breast enlargement (2), female breast pain (2), leukorrhea (2), menorrhagia (2), atrophic vaginitis (2).

(1) - % based on male subjects only: 1005
(2) - % based on female subjects only: 1705

Zoloft effects

Respiratory System Disorders:
Infrequent: Bronchospasm, coughing, dyspnea, epistaxis. Rare: Bradypnea, hyperventilation, sinusitis, stridor.

Special Senses:
Infrequent: Abnormal accommodation, conjunctivitis, diplopia, earache, eye pain, xerophthalmia. Rare: Abnormal lacrimation, photophobia, visual field defect.

Urinary System Disorders:
Infrequent: Dysuria, face edema, nocturia, polyuria, urinary incontinence. Rare: Oliguria, renal pain, urinary retention.

Laboratory Tests:
In man, asymptomatic elevations in serum hepatic transaminases [AST (SGOT) and ALT (SGPT)] to a value >=3 times the upper limit of normal have been reported infrequently (approximately 0.6% and 1.1%, respectively) in association with sertraline administration. The proportion of patients having these elevations was greater in the sertraline group than in the placebo group. These hepatic enzyme elevations usually occurred within the first 1 to 9 weeks of drug treatment and promptly diminished upon drug discontinuation.

Sertraline 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.

What does my medication look like?

Sertraline is available with a prescription under the brand name Zoloft. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

*Zoloft 25 mg - capsule -shaped, green, film-coated, scored tablets
*Zoloft 50 mg - capsule-shaped, light-blue, film-coated, scored tablets
*Zoloft 100 mg - capsule-shaped, light-yellow, film-coated, scored tablets
*Zoloft Oral Concentrate 20 mg/mL - clear, colorless solution with a menthol scent

Zoloft effects

* Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
* Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (’Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

HOW SUPPLIED

Sertraline hydrochloride capsular-shaped scored tablets, equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles.

Sertraline hydrochloride 25 mg Tablets: light green capsular-shaped scored tablets engraved on one side with G 4960 and on the other side engraved with 25 mg.

NDC 59762-4960-1 Bottles of 30

Sertraline hydrochloride 50 mg Tablets: light blue capsular-shaped scored tablets engraved on one side with G 4900 and on the other side engraved with 50 mg.

NDC 59762-4900-1 Bottles of 30
NDC 59762-4900-4 Bottles of 100
NDC 59762-4900-5 Bottles of 500
NDC 59762-4900-2 Bottles of 5000
NDC 59762-4900-3 Unit Dose Packages of 100

Sertraline hydrochloride 100 mg Tablets: light yellow capsular-shaped scored tablets engraved on one side with G 4910 and on the side engraved with 100 mg.

NDC 59762-4910-1 Bottles of 30
NDC 59762-4910-4 Bottles of 100
NDC 59762-4910-5 Bottles of 500
NDC 59762-4910-2 Bottles of 5000
NDC 59762-4910-3 Unit Dose Packages of 100

Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F)[see USP Controlled Room Temperature].

Sertraline hydrochloride Oral Concentrate: sertraline hydrochloride Oral Concentrate is a clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol. It is supplied as a 60 mL bottle with an accompanying calibrated dropper.

NDC 59762-4940-1 Bottles of 60 mL

Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86°F) [see USP Controlled Room Temperature].