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Prozac (Fluoxetine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Multiple doses of Prozac had been administered to 10,782 patients with various diagnoses in US clinical trials as of May 8, 1995. In addition, there have been 425 patients administered Prozac in panic clinical trials. Adverse events were recorded by clinical investigators using descriptive 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 events into a limited (i.e., reduced) number of standardized event categories.

In the tables and tabulations that follow, COSTART Dictionary terminology has been used to classify reported adverse events. The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. 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 nondrug factors to the side effect incidence rate in the population studied.

Incidence in major depressive disorder, OCD, bulimia, and panic disorder placebo-controlled clinical trials (excluding data from extensions of trials) -- Table 1 enumerates the most common treatment-emergent adverse events associated with the use of Prozac (incidence of at least 5% for Prozac and at least twice that for placebo within at least 1 of the indications) for the treatment of major depressive disorder, OCD, and bulimia in US controlled clinical trials and panic disorder in US plus non-US controlled trials. Table 2 enumerates treatment-emergent adverse events that occurred in 2% or more patients treated with Prozac and with incidence greater than placebo who participated in US major depressive disorder, OCD, and bulimia controlled clinical trials and US plus non-US panic disorder controlled clinical trials. Table 2 provides combined data for the pool of studies that are provided separately by indication in Table 1.

Table 1: Most Common Treatment-Emergent Adverse Events: Incidence in Major
Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials 1
Percentage of Patients Reporting Event
Major Depressive Disorder OCD Bulimia Panic Disorder
Body System/ Adverse Event Prozac
(N=1728)
Placebo
(N=975)
Prozac
(N=266)
Placebo
(N=89)
Prozac
(N=450)
Placebo
(N=267)
Prozac
(N=425)
Placebo
(N=342)
Body as a Whole
Asthenia 9 5 15 11 21 9 7 7
Flu syndrome 3 4 10 7 8 3 5 5
Cardiovascular System
Vasodilatation 3 2 5 -- 2 1 1 --
Digestive System
Nausea 21 9 26 13 29 11 12 7
Diarrhea 12 8 18 13 8 6 9 4
Anorexia 11 2 17 10 8 4 4 1
Dry mouth 10 7 12 3 9 6 4 4
Dyspepsia 7 5 10 4 10 6 6 2
Nervous System
Insomnia 16 9 28 22 33 13 10 7
Anxiety 12 7 14 7 15 9 6 2
Nervousness 14 9 14 15 11 5 8 6
Somnolence 13 6 17 7 13 5 5 2
Tremor 10 3 9 1 13 1 3 1
Libido decreased 3 -- 11 2 5 1 1 2
Abnormal dreams 1 1 5 2 5 3 1 1
Respiratory System
Pharyngitis 3 3 11 9 10 5 3 3
Sinusitis 1 4 5 2 6 4 2 3
Yawn -- -- 7 -- 11 -- 1 --
Skin and Appendages
Sweating 8 3 7 -- 8 3 2 2
Rash 4 3 6 3 4 4 2 2
Urogenital System
Impotence 2 2 -- -- -- 7 -- 1 --
Abnormal ejaculation 2 -- -- 7 -- 7 -- 2 1
1 Includes US data for major depressive disorder, OCD, bulimia, and panic disorder clinical trials, plus non-US data for panic disorder clinical trials.
2 Denominator used was for males only (N=690 Prozac major depressive disorder; N=410 placebo major depressive disorder; N=116 Prozac OCD; N=43 placebo OCD; N=14 Prozac bulimia; N=1 placebo bulimia; N=162 Prozac panic; N=121 placebo panic).
--Incidence less than 1%.

Table 2: Treatment-Emergent Adverse Events: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials1
Percentage of
Patients Reporting Event
Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Combined
Body System/ Adverse Event 2 Prozac
(N=2869)
Placebo
(N=1673)
Body as a Whole
Headache 21 19
Asthenia 11 6
Flu syndrome 5 4
Fever 2 1
Cardiovascular System
Vasodilatation 2 1
Digestive System
Nausea 22 9
Diarrhea 11 7
Anorexia 10 3
Dry mouth 9 6
Dyspepsia 8 4
Constipation 5 4
Flatulence 3 2
Vomiting 3 2
Metabolic and Nutritional Disorders
Weight loss 2 1
Nervous System
Insomnia 19 10
Nervousness 13 8
Anxiety 12 6
Somnolence 12 5
Dizziness 9 6
Tremor 9 2
Libido decreased 4 1
Thinking abnormal 2 1
Respiratory System
Yawn 3 --
Skin and Appendages
Sweating 7 3
Rash 4 3
Pruritus 3 2
Special Senses
Abnormal vision 2 1
1 Includes US data for major depressive disorder, OCD, bulimia, and panic disorder clinical trials, plus non-US data for panic disorder clinical trials.
2 Included are events reported by at least 2% of patients taking Prozac, except the following events, which had an incidence on placebo ≥ Prozac (major depressive disorder, OCD, bulimia, and panic disorder combined): abdominal pain, abnormal dreams, accidental injury, back pain, cough increased, major depressive disorder (includes suicidal thoughts), dysmenorrhea, infection, myalgia, pain, paresthesia, pharyngitis, rhinitis, sinusitis.
--Incidence less than 1%.

Associated with discontinuation in major depressive disorder, OCD, bulimia, and panic disorder placebo-controlled clinical trials (excluding data from extensions of trials) --Table 3 lists the adverse events associated with discontinuation of Prozac treatment (incidence at least twice that for placebo and at least 1% for Prozac in clinical trials collecting only a primary event associated with discontinuation) in major depressive disorder, OCD, bulimia, and panic disorder clinical trials, plus non-US panic disorder clinical trials.

Table 3: Most Common Adverse Events Associated with Discontinuation in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials 1
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%) -- --
1 Includes US major depressive disorder, OCD, bulimia, and panic disorder clinical trials, plus non-US panic disorder clinical trials.

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 1 and 2. However, the following adverse events (excluding those which appear in the body or footnotes of Tables 1 and 2 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 3 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.

Events observed in Prozac Weekly clinical trials -- Treatment-emergent adverse events in clinical trials with Prozac Weekly were similar to the adverse events reported by patients in clinical trials with Prozac daily. In a placebo-controlled clinical trial, more patients taking Prozac Weekly reported diarrhea than patients taking placebo (10% versus 3%, respectively) or taking Prozac 20 mg daily (10% versus 5%, respectively).

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 US 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 US clinical trials as of May 8, 1995 (10,782 patients) except (1) those listed in the body or footnotes of Tables 1 or 2 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 Prozac use was considered remote; and (4) events occurring in only 1 patient treated with Prozac 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 1/1000 patients; rare events are those occurring in less than 1/1000 patients.

Body as a Whole -- Frequent: chest pain, chills; Infrequent: chills and fever, face edema, intentional overdose, malaise, pelvic pain, suicide attempt; Rare: abdominal syndrome acute, hypothermia, intentional injury, neuroleptic malignant syndrome 1, photosensitivity reaction.

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.

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 3, anorgasmia, breast enlargement, breast pain, cystitis, dysuria, female lactation 3, fibrocystic breast 3, hematuria, leukorrhea 3, menorrhagia 3, metrorrhagia 3, nocturia, polyuria, urinary incontinence, urinary retention, urinary urgency, vaginal hemorrhage 3 ; Rare: breast engorgement, glycosuria, hypomenorrhea 3, kidney pain, oliguria, priapism 3, uterine hemorrhage 3, uterine fibroids enlarged 3.

1 Neuroleptic malignant syndrome is the COSTART term which best captures serotonin syndrome.
2 Personality disorder is the COSTART term for designating nonaggressive objectionable behavior.
3 Adjusted for gender.

POSTINTRODUCTION REPORTS

Voluntary reports of adverse events temporally associated with Prozac that have been received since market introduction and that may have no causal relationship with the drug include the following: aplastic anemia, atrial fibrillation, cataract, cerebral vascular accident, cholestatic jaundice, confusion, dyskinesia (including, for example, a case of buccal-lingual-masticatory syndrome with involuntary tongue protrusion reported to develop in a 77-year-old female after 5 weeks of fluoxetine therapy and which completely resolved over the next few months following drug discontinuation), eosinophilic pneumonia, epidermal necrolysis, erythema nodosum, exfoliative dermatitis, gynecomastia, heart arrest, hepatic failure/necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, kidney failure, misuse/abuse, movement disorders developing in patients with risk factors including drugs associated with such events and worsening of preexisting movement disorders, neuroleptic malignant syndrome-like events, optic neuritis, pancreatitis, pancytopenia, priapism, pulmonary embolism, pulmonary hypertension, QT prolongation, serotonin syndrome (a range of signs and symptoms that can rarely, in its most severe form, resemble neuroleptic malignant syndrome), Stevens-Johnson syndrome, sudden unexpected death, suicidal ideation, thrombocytopenia, thrombocytopenic purpura, vaginal bleeding after drug withdrawal, ventricular tachycardia (including torsades de pointes-type arrhythmias), and violent behaviors.



REPORTS OF SUSPECTED PROZAC SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Prozac side effects / adverse reactions in 45 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 45 year old female

Reactions: Drug Ineffective, Brain Neoplasm, Convulsion

Suspect drug(s):
Prozac
    Dosage: unk unk, unknown

Cymbalta
    Dosage: 30 mg, qd
    Indication: Depression
    Start date: 2011-09-01
    End date: 2011-09-01

Prozac
    Dosage: unk, unknown
    Start date: 2011-09-01
    End date: 2011-09-01



Possible Prozac side effects / adverse reactions in 29 year old female

Reported by a consumer/non-health professional from United States on 2011-10-07

Patient: 29 year old female

Reactions: Postpartum Disorder, Paraesthesia Oral, Maternal Exposure During Pregnancy, Quality of Life Decreased, Drug Withdrawal Syndrome, Abortion Spontaneous, Paraesthesia, Weight Increased, Anxiety, Hallucination, Visual, Withdrawal Syndrome, Heart Rate Irregular

Suspect drug(s):
Paxil
    Dosage: 15mg per day
    Administration route: Oral
    Indication: Panic Disorder
    Start date: 2000-01-01

Paxil CR
    Dosage: 20mg per day
    Indication: Panic Disorder

Prozac
    Indication: Postpartum Disorder

Other drugs received by patient: NO Concurrent Medication



Possible Prozac side effects / adverse reactions in 53 year old female

Reported by a physician from United States on 2011-10-11

Patient: 53 year old female

Reactions: Anxiety, Feeling Abnormal

Suspect drug(s):
Prozac



See index of all Prozac side effect reports >>

Drug label data at the top of this Page last updated: 2006-11-19

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