Sertraline (Page 3 of 8)

6 ADVERSE REACTIONS

The following adverse reactions are described in more detail in other sections of the prescribing information:

Hypersensitivity reactions to sertraline [See Contraindications (4)]
QT prolongation and ventricular arrhythmias when taken with pimozide [See Contraindications (4)]
Suicidal thoughts and behaviors [See Warnings and Precautions (5.1)]
Serotonin syndrome [See Contraindications (4), Warnings and Precautions (5.2), Drug Interactions (7.1)]
Increased risk of bleeding [See Warnings and Precautions (5.3)]
Activation of mania/hypomania [See Warnings and Precautions (5.4)]
Discontinuation syndrome [See Warnings and Precautions (5.5)]
Seizures [See Warnings and Precautions (5.6)]
Angle-closure glaucoma [See Warnings and Precautions (5.7)]
Hyponatremia [See Warnings and Precautions (5.8)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below are from randomized, double-blind, placebo-controlled trials of sertraline hydrochloride (mostly 50 mg to 200 mg per day) in 3066 adults diagnosed with MDD, OCD, PD, PTSD, SAD, and PMDD. These 3066 patients exposed to sertraline hydrochloride

for 8 to12 weeks represent 568 patient-years of exposure. The mean age was 40 years; 57% were females and 43% were males.

The most common adverse reactions (≥5% and twice placebo) in all pooled placebo-controlled clinical trials of all sertraline hydrochloride-treated patients with MDD, OCD, PD, PTSD, SAD and PMDD were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 3). The following are the most common adverse reactions in trials of sertraline hydrochloride (≥5% and twice placebo) by indication that were not mentioned previously.

MDD: somnolence;
OCD: insomnia, agitation;
PD: constipation, agitation;
PTSD: fatigue;
PMDD: somnolence, dry mouth, dizziness, fatigue, and abdominal pain;
SAD: insomnia, dizziness, fatigue, dry mouth, malaise.

Table 3: Common Adverse Reactions in Pooled Placebo-Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD*

*
Adverse reactions that occurred greater than 2% in sertraline hydrochloride-treated patients and at least 2% greater in sertraline hydrochloride-treated patients than placebo-treated patients.


Sertraline Hydrochloride
(N=3066)
Placebo
(N=2293)
Cardiac disorders
Palpitations
4%
2%
Eye disorders
Visual impairment
4%
2%
Gastrointestinal Disorders
Nausea
26%
12%
Diarrhea/Loose Stools
20%
10%
Dry mouth
14%
9%
Dyspepsia
8%
4%
Constipation
6%
4%
Vomiting
4%
1%
General disorders and administration site conditions
Fatigue
12%
8%
Metabolism and nutrition disorders
Decreased appetite
7%
2%
Nervous system disorders
Dizziness
12%
8%
Somnolence
11%
6%
Tremor
9%
2%
Psychiatric Disorders
Insomnia
20%
13%
Agitation
8%
5%
Libido Decreased
6%
2%
Reproductive System and Breast Disorders
Ejaculation failure(1)
8%
1%
Erectile dysfunction(1)
4%
1%
Ejaculation disorder(1)
3%
0%
Male sexual dysfunction(1)
2%
0%
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis
7%
3%

Adverse Reactions Leading to Discontinuation in Placebo-Controlled Clinical Trials

In all placebo-controlled studies in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 368 (12%) of the 3066 patients who received sertraline hydrochloride discontinued treatment due to an adverse reaction, compared with 93 (4%) of the 2293 placebo-treated patients. In placebo-controlled studies, the following were the common adverse reactions leading to discontinuation in sertraline hydrochloride-treated patients:

MDD, OCD, PD, PTSD, SAD and PMDD: nausea (3%), diarrhea (2%), agitation (2%), and insomnia (2%).
MDD (>2% and twice placebo): decreased appetite, dizziness, fatigue, headache, somnolence, tremor, and vomiting.
OCD: somnolence.
PD: nervousness and somnolence.

Male and Female Sexual Dysfunction

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 SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.

Table 4 below displays the incidence of sexual adverse reactions reported by at least 2% of sertraline hydrochloride-treated patients and twice placebo from pooled placebo-controlled trials. For men and all indications, the most common adverse reactions (>2% and twice placebo) included: ejaculation failure, decreased libido, erectile dysfunction, ejaculation disorder, and male sexual dysfunction. For women, the most common adverse reaction (≥2% and twice placebo) was decreased libido.

Table 4: Most Common Sexual Adverse Reactions (≥2% and twice placebo) in Men or Women from Sertraline Hydrochloride Pooled Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD
Sertraline Hydrochloride
Placebo
Men only
(N=1316)
(N=973)
Ejaculation failure
8%
1%
Libido decreased
7%
2%
Erectile dysfunction
4%
1%
Ejaculation disorder
3%
0%
Male sexual dysfunction
2%
0%
Women only
(N=1750)
(N=1320)
Libido decreased
4%
2%

Adverse Reactions in Pediatric Patients

In 281 pediatric patients treated with sertraline hydrochloride in placebo-controlled studies, the overall profile of adverse reactions was generally similar to that seen in adult studies. Adverse reactions that do not appear in Table 3 (most common adverse reactions in adults) yet were reported in at least 2% of pediatric patients and at a rate of at least twice the placebo rate include fever, hyperkinesia, urinary incontinence, aggression, epistaxis, purpura, arthralgia, decreased weight, muscle twitching, and anxiety.

Other Adverse Reactions Observed During the Premarketing Evaluation of Sertraline Hydrochloride

Other infrequent adverse reactions, not described elsewhere in the prescribing information, occurring at an incidence of < 2% in patients treated with sertraline hydrochloride were:

Cardiac Disorders:

Tachycardia

Ear and Labyrinth Disorders:

Tinnitus

Endocrine Disorders:

Hypothyroidism

Eye Disorders:

Mydriasis, blurred vision

Gastrointestinal Disorders:

Hematochezia, melena, rectal hemorrhage

General Disorders and Administration Site Conditions:

Edema, gait disturbance, irritability, pyrexia

Hepatobiliary Disorders:

Elevated liver enzymes

Immune System Disorders:

Anaphylaxis

Metabolism and Nutrition Disorders:

Diabetes mellitus, hypercholesterolemia, hypoglycemia, increased appetite

Musculoskeletal and Connective Tissue Disorders:

Arthralgia, muscle spasms, tightness, or twitching

Nervous System Disorders:

Ataxia, coma, convulsion, decreased alertness, hypoesthesia, lethargy, psychomotor hyperactivity, syncope

Psychiatric Disorders:

Aggression, bruxism, confusional state, euphoric mood, hallucination

Renal and Urinary Disorders:

Hematuria

Reproductive System and Breast Disorders:

Galactorrhea, priapism, vaginal hemorrhage

Respiratory, Thoracic and Mediastinal Disorders:

Bronchospasm, epistaxis, yawning

Skin and Subcutaneous Tissue Disorders:

Alopecia; cold sweat; dermatitis; dermatitis bullous; pruritus; purpura; erythematous, follicular, or maculopapular rash; urticarial

Vascular Disorders:

Hemorrhage, hypertension, vasodilation

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of sertraline hydrochloride tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Bleeding or Clotting Disorders

Increased coagulation times (altered platelet function)

Cardiac Disorders

AV block, bradycardia, atrial arrhythmias, QT-interval prolongation, ventricular tachycardia (including Torsade de Pointes)

Endocrine Disorders

Gynecomastia, hyperprolactinemia, menstrual irregularities, SIADH

Eye Disorders

Blindness, optic neuritis, cataract

Hepatobiliary Disorders

Severe liver events (including hepatitis, jaundice, liver failure with some fatal outcomes), pancreatitis

Hemic and Lymphatic

Agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness

Immune System Disorders

Angioedema

Metabolism and Nutrition Disorders

Hyponatremia, hyperglycemia

Nervous System Disorders

Serotonin syndrome, extrapyramidal symptoms (including akathisia and dystonia), oculogyric crisis

Psychiatric Disorders

Psychosis, enuresis, paroniria

Renal and Urinary Disorders

Acute renal failure

Respiratory, Thoracic and Mediastinal Disorders

Pulmonary hypertension

Skin and Subcutaneous Tissue Disorders

Photosensitivity skin reaction and other severe cutaneous reactions, which potentially can be fatal, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)

Vascular Disorders

Cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call- Fleming syndrome), vasculitis

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