Prescription Drug Information: Fluoxetine Hydrochloride (Page 8 of 11)

Associated with Discontinuation in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials (excluding data from extensions of trials)

Table 4 lists the adverse events associated with discontinuation of fluoxetine treatment (incidence at least twice that for placebo and at least 1% for fluoxetine in clinical trials collecting only a primary event associated with discontinuation) in major depressive disorder, OCD, bulimia, and panic disorder clinical trials, plus non-U.S. panic disorder clinical trials.

Table 4 Most Common Adverse Events Associated with Discontinuation in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials1

1 Includes U.S. data for major depressive disorder, OCD, bulimia, and panic disorder clinical trials, plus non-U.S. data for panic disorder clinical trials.

Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Combined (N=1533) Major Depressive Disorder (N=392) OCD (N=266) Bulimia (N=450) Panic Disorder (N=425)
Anxiety (1%) Anxiety (2%) Anxiety (2%)
Insomnia (2%)
Nervousness (1%) Nervousness (1%)
Rash (1%)

Other Adverse Events in Pediatric Patients (Children and Adolescents)

Treatment-emergent adverse events were collected in 322 pediatric patients (180 fluoxetine-treated, 142 placebo-treated). The overall profile of adverse events was generally similar to that seen in adult studies, as shown in Tables 2 and 3. However, the following adverse events (excluding those which appear in the body or footnotes of Tables 2 and 3 and those for which the COSTART terms were uninformative or misleading) were reported at an incidence of at least 2% for fluoxetine and greater than placebo: thirst, hyperkinesia, agitation, personality disorder, epistaxis, urinary frequency, and menorrhagia.

The most common adverse event (incidence at least 1% for fluoxetine and greater than placebo) associated with discontinuation in three pediatric placebo-controlled trials (N=418 randomized; 228 fluoxetine-treated; 190 placebo-treated) was mania/hypomania (1.8% for fluoxetine-treated, 0% for placebo-treated). In these clinical trials, only a primary event associated with discontinuation was collected.

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 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. In patients enrolled in U.S. major depressive disorder, OCD, and bulimia placebo-controlled clinical trials, decreased libido was the only sexual side effect reported by at least 2% of patients taking fluoxetine (4% fluoxetine, <1% placebo). There have been spontaneous reports in women taking fluoxetine of orgasmic dysfunction, including anorgasmia.

There are no adequate and well-controlled studies examining sexual dysfunction with fluoxetine 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 Events Observed In Clinical Trials

Following is a list of all treatment-emergent adverse events reported at anytime by individuals taking fluoxetine in U.S. clinical trials as of May 8, 1995 (10,782 patients) except (1) those listed in the body or footnotes of Tables 2 or 3 above or elsewhere in labeling; (2) those for which the COSTART terms were uninformative or misleading; (3) those events for which a causal relationship to fluoxetine use was considered remote; and (4) events occurring in only 1 patient treated with fluoxetine and which did not have a substantial probability of being acutely life-threatening.

Events are classified within body system categories using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in less than 1/1,000 patients.

Body as a Whole

Frequent: Chest pain, chills

Infrequent: Chills and fever, face edema, intentional overdose, malaise, pelvic pain, suicide attempt

Rare: Acute abdominal syndrome, hypothermia, intentional injury, neuroleptic malignant syndrome**1, photosensitivity reaction


1

**Neuroleptic malignant syndrome is the COSTART term which best captures serotonin syndrome

Cardiovascular System

Frequent: Hemorrhage, hypertension, palpitation

Infrequent: Angina pectoris, arrhythmia, congestive heart failure, hypotension, migraine, myocardial infarct, postural hypotension, syncope, tachycardia, vascular headache

Rare: Atrial fibrillation, bradycardia, cerebral embolism, cerebral ischemia, cerebrovascular accident, extrasystoles, heart arrest, heart block, pallor, peripheral vascular disorder, phlebitis, shock, thrombophlebitis, thrombosis, vasospasm, ventricular arrhythmia, ventricular extrasystoles, ventricular fibrillation

Digestive System

Frequent: Increased appetite, nausea and vomiting

Infrequent: Aphthous stomatitis, cholelithiasis, colitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, glossitis, gum hemorrhage,

hyperchlorhydria, increased salivation, liver function tests abnormal, melena, mouth ulceration, nausea/vomiting/diarrhea, stomach ulcer, stomatitis, thirst

Rare: Biliary pain, bloody diarrhea, cholecystitis, duodenal ulcer, enteritis, esophageal ulcer, fecal incontinence, gastrointestinal hemorrhage, hematemesis, hemorrhage of colon, hepatitis, intestinal obstruction, liver fatty deposit, pancreatitis, peptic ulcer, rectal hemorrhage, salivary gland enlargement, stomach ulcer hemorrhage, tongue edema

Endocrine System

Infrequent: Hypothyroidism

Rare: Diabetic acidosis, diabetes mellitus

Hemic and Lymphatic System

Infrequent: Anemia, ecchymosis

Rare: Blood dyscrasia, hypochromic anemia, leukopenia, lymphedema, lymphocytosis, petechia, purpura, thrombocythemia, thrombocytopenia

Metabolic and Nutritional

Frequent: Weight gain

Infrequent: Dehydration, generalized edema, gout, hypercholesteremia, hyperlipemia, hypokalemia, peripheral edema

Rare: Alcohol intolerance, alkaline phosphatase increased, BUN increased, creatine phosphokinase increased, hyperkalemia, hyperuricemia, hypocalcemia, iron deficiency anemia, SGPT increased

Musculoskeletal System

Infrequent: Arthritis, bone pain, bursitis, leg cramps, tenosynovitis

Rare: Arthrosis, chondrodystrophy, myasthenia, myopathy, myositis, osteomyelitis, osteoporosis, rheumatoid arthritis

Nervous System

Frequent: Agitation, amnesia, confusion, emotional lability, sleep disorder

Infrequent: Abnormal gait, acute brain syndrome, akathisia, apathy, ataxia, buccoglossal syndrome, CNS depression, CNS stimulation, depersonalization, euphoria, hallucinations, hostility, hyperkinesia, hypertonia, hypesthesia, incoordination, libido increased, myoclonus, neuralgia, neuropathy, neurosis, paranoid reaction, personality disorder†2, psychosis, vertigo

Rare: Abnormal electroencephalogram, antisocial reaction, circumoral paresthesia, coma, delusions, dysarthria, dystonia, extrapyramidal syndrome, foot drop, hyperesthesia, neuritis, paralysis, reflexes decreased, reflexes increased, stupor


2

†Personality disorder is the COSTART term for designating nonaggressive objectionable behavior

Respiratory System

Infrequent: Asthma, epistaxis, hiccup, hyperventilation

Rare: Apnea, atelectasis, cough decreased, emphysema, hemoptysis, hypoventilation, hypoxia, larynx edema, lung edema, pneumothorax, stridor

Skin and Appendages

Infrequent: Acne, alopecia, contact dermatitis, eczema, maculopapular rash, skin discoloration, skin ulcer, vesiculobullous rash

Rare: Furunculosis, herpes zoster, hirsutism, petechial rash, psoriasis, purpuric rash, pustular rash, seborrhea

Special Senses

Frequent: Ear pain, taste perversion, tinnitus

Infrequent: Conjunctivitis, dry eyes, mydriasis, photophobia

Rare: Blepharitis, deafness, diplopia, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, iritis, parosmia, scleritis, strabismus, taste loss, visual field defect

Urogenital System

Frequent: Urinary frequency

Infrequent: Abortion*3, albuminuria, amenorrhea*4, anorgasmia, breast enlargement, breast pain, cystitis, dysuria, female lactation*5, fibrocystic breast*6, hematuria, leukorrhea*7, menorrhagia*8, metrorrhagia*9, nocturia, polyuria, urinary incontinence, urinary retention, urinary urgency, vaginal hemorrhage*10

Rare: Breast engorgement, glycosuria, hypomenorrhea*11, kidney pain, oliguria, priapism*12, uterine hemorrhage*13, uterine fibroids enlarged*14

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