The following information comes from DailyMed, an FDA label information provider.
Adverse Reactions
During its premarketing assessment, multiple doses of Sertraline were administered to over 4000 adult subjects as of February 18, 2000. 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 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.
Side effects include but are not limited to:
- Nausea
- Dry mouth
- Appetite change
- Problems with sleep
- Tiredness or fatigue
- Shaking
- Anxiety
- Headache
- Sweating
Severe side effects include but are not limited to:
- Seizures
- Bleeding
- Rash or hives
- Difficulty breathing
- Hallucinations
- Vomiting
- Confusion
Male and Female Sexual Dysfunction with SSRIs
Sexual dysfunction with SSRIs may include:
- ejaculation failure, or, delayed ejaculation
- decreased libido
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 Sertraline, 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 Sertraline): 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 Sertraline in clinical trials (over 4000 adult subjects) except those already listed in the previous tables or elsewhere in labeling.
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, paranoia, 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.
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