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Prozac

Last reviewed on RxList: 12/11/2018
Prozac Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/11/2018

Prozac (fluoxetine) is a type of antidepressant called a selective serotonin reuptake inhibitor (SSRI) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphoric disorder (PMDD). Prozac is available in generic form. Side effects of Prozac include:

The recommended dose of Prozac is 10-80 mg daily. Prozac should not be taken with monoamine oxidase inhibitors (MAOI) (for example, isocarboxazid [Marplan)]. Prozac should not be administered for at least 14 days after stopping and MAOIs should not be administered for at least 5 weeks after Prozac has been stopped. Use of Prozac during the third trimester of pregnancy may lead to adverse effects in the newborn. Tell your doctor if you become pregnant while taking Prozac. Prozac may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant. Do not start or stop taking Prozac during pregnancy without your doctor's advice. Prozac passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding. Some patients may experience withdrawal reactions such nausea, nervousness, and insomnia upon stopping Prozac.

Our Prozac Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Prozac Consumer Information

Get emergency medical help if you have signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
  • low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or
  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • sleep problems (insomnia), strange dreams;
  • headache, dizziness, vision changes;
  • tremors or shaking, feeling anxious or nervous;
  • pain, weakness, yawning, tired feeling;
  • upset stomach, loss of appetite, nausea, vomiting, diarrhea;
  • dry mouth, sweating, hot flashes;
  • changes in weight or appetite;
  • stuffy nose, sinus pain, sore throat, flu symptoms; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Prozac (Fluoxetine Hcl)

Prozac Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

When using PROZAC and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax.

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 or predict the rates observed in practice.

Multiple doses of PROZAC have been administered to 10,782 patients with various diagnoses in US clinical trials. In addition, there have been 425 patients administered PROZAC in panic clinical trials. The stated frequencies represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Incidence In Major Depressive Disorder, OCD, Bulimia, And Panic Disorder Placebo-Controlled Clinical Trials (Excluding Data From Extensions Of Trials)

Table 3 enumerates the most common treatment-emergent adverse reactions 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 5 enumerates treatment-emergent adverse reactions 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 4 provides combined data for the pool of studies that are provided separately by indication in Table 3.

Table 3: Most Common Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials1,2

Percentage of Patients Reporting Event
  Major Depressive Disorder OCD Bulimia Panic Disorder
Body System/ Adverse Reaction 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                
  Impotence3 2 - - - 7 - 1 -
  Abnormal ejaculation3 - - 7 - 7 - 2 1
1 Incidence less than 1%.
2 Includes US data for Major Depressive Disorder, OCD, Bulimia, and Panic Disorder clinical trials, plus non-US data for Panic Disorder clinical trials.
3 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).

Table 4: Treatment-Emergent Adverse Reactions: Incidence in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials1,2

Body System / Adverse Reaction Percentage of Patients Reporting Event
Major Depressive Disorder, OCD, Bulimia,and Panic Disorder Combined
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 Incidence less than 1%.
2 Includes US data for Major Depressive Disorder, OCD, Bulimia, and Panic Disorder clinical trials, plus non-US data for Panic Disorder clinical trials.

Associated With Discontinuation In Major Depressive Disorder, OCD, Bulimia, And Panic Disorder Placebo-Controlled Clinical Trials (Excluding Data From Extensions Of Trials)

Table 5 lists the adverse reactions 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 reaction associated with discontinuation) in Major Depressive Disorder, OCD, bulimia, and Panic Disorder clinical trials, plus non-US Panic Disorder clinical trials.

Table 5: Most Common Adverse Reactions Associated with Discontinuation in Major Depressive Disorder, OCD, Bulimia, and Panic Disorder Placebo-Controlled Clinical Trials1

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%) - -
1Includes US Major Depressive Disorder, OCD, Bulimia, and Panic Disorder clinical trials, plus non-US Panic Disorder clinical trials.

Other Adverse Reactions In Pediatric Patients (Children And Adolescents)

Treatment-emergent adverse reactions were collected in 322 pediatric patients (180 fluoxetine-treated, 142 placebo-treated). The overall profile of adverse reactions was generally similar to that seen in adult studies, as shown in Tables 4 and 5. However, the following adverse reactions (excluding those which appear in the body or footnotes of Tables 4 and 5 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 reaction (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 reaction associated with discontinuation was collected.

Reactions Observed In PROZAC Weekly Clinical Trials

Treatment-emergent adverse reactions in clinical trials with PROZAC Weekly were similar to the adverse reactions 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.

Symptoms of sexual dysfunction occasionally persist after discontinuation of 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 Reactions

Following is a list of treatment-emergent adverse reactions reported by patients treated with fluoxetine in clinical trials. This listing is not intended to include reactions (1) already listed in previous tables or elsewhere in labeling, (2) for which a drug cause was remote, (3) which were so general as to be uninformative, (4) which were not considered to have significant clinical implications, or (5) which occurred at a rate equal to or less than placebo.

Reactions are classified by body system using the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients.

Body As A Whole

Frequent: chills; Infrequent: suicide attempt; Rare: acute abdominal syndrome, photosensitivity reaction.

Cardiovascular System

Frequent: palpitation; Infrequent: arrhythmia, hypotension1.

Digestive System

Infrequent: dysphagia, gastritis, gastroenteritis, melena, stomach ulcer; Rare: bloody diarrhea, duodenal ulcer, esophageal ulcer, gastrointestinal hemorrhage, hematemesis, hepatitis, peptic ulcer, stomach ulcer hemorrhage.

Hemic And Lymphatic System

Infrequent: ecchymosis; Rare: petechia, purpura.

Nervous System

Frequent: emotional lability; Infrequent: akathisia, ataxia, balance disorder1, bruxism1, buccoglossa1 syndrome, depersonalization, euphoria, hypertonia, libido increased, myoclonus, paranoid reaction; Rare: delusions.

Respiratory System

Rare: larynx edema.

Skin And Appendages

Infrequent:alopecia; Rare: purpuric rash.

Special Senses

Frequent:taste perversion; Infrequent: mydriasis.

Urogenital System

Frequent:micturition disorder; Infrequent: dysuria, gynecological bleeding2 .

1MedDRA dictionary term from integrated database of placebo controlled trials of 15870 patients, of which 9673 patients received fluoxetine.
2Group term that includes individual MedDRA terms: cervix hemorrhage uterine, dysfunctional uterine bleeding, genital hemorrhage, menometrorrhagia, menorrhagia, metrorrhagia, polymenorrhea, postmenopausal hemorrhage, uterine hemorrhage, vaginal hemorrhage. Adjusted for gender.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of PROZAC. Because these reactions are reported voluntarily from a population of uncertain size, it is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure.

Voluntary reports of adverse reactions 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 fibrillation1, cataract, cerebrovascular accident1, cholestatic jaundice, 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 pneumonia1, epidermal necrolysis, erythema multiforme, erythema nodosum, exfoliative dermatitis, galactorrhea, gynecomastia, heart arrest1, hepatic failure/necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, kidney failure, memory impairment, movement disorders developing in patients with risk factors including drugs associated with such reactions and worsening of pre-existing movement disorders, optic neuritis, pancreatitis1, pancytopenia, pulmonary embolism, pulmonary hypertension, QT prolongation, Stevens-Johnson syndrome, thrombocytopenia1, thrombocytopenic purpura, ventricular tachycardia (including Torsades de Pointes–type arrhythmias), vaginal bleeding, and violent behaviors1.

1These terms represent serious adverse events, but do not meet the definition for adverse drug reactions. They are included here because of their seriousness.

Read the entire FDA prescribing information for Prozac (Fluoxetine Hcl)

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