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Prozac Side Effects

Common Prozac Side Effects


The most commonly reported Prozac side effects (click to view or check a box to report):

Depression (140)
Anxiety (110)
Suicidal Ideation (96)
Feeling Abnormal (92)
Aggression (81)
Completed Suicide (81)
Nausea (74)
Headache (73)
Suicide Attempt (71)
Agitation (67)
Abnormal Behaviour (66)
Insomnia (66)
Vomiting (66)
Pain (63)
Fall (61)
Dyspnoea (56)
Convulsion (55)
Fatigue (53)
Tremor (47)
Confusional State (46)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Prozac Side Effects Reported to FDA

The following Prozac reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Prozac on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Cardiogenic Shock, Hypothermia, Hypotension, Bradycardia, Electrocardiogram Qt Prolonged, Overdose
This is a report of a 53-year-old female patient (weight: NA) from FR, suffering from the following symptoms/conditions: NA, who was treated with Prozac (dosage: NA, start time: NS), combined with:
  • Avlocardyl /00030001/ (640 Mg, Qd)
  • Anafranil (4000 Mg, Qd)
  • Nuctalon (40 Mg, Qd)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Cardiogenic Shock
  • Hypothermia
  • Hypotension
  • Bradycardia
  • Electrocardiogram Qt Prolonged
  • Overdose
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prozac treatment in female patients, resulting in cardiogenic shock side effect. The patient was hospitalized.

Osteonecrosis Of Jaw
This report suggests a potential Prozac Osteonecrosis Of Jaw side effect(s) that can have serious consequences. A 69-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Prozac (dosage: 20 Mg, Unk) starting Jun 21, 2011. Soon after starting Prozac the patient began experiencing various side effects, including:
  • Osteonecrosis Of Jaw
Drugs used concurrently:
  • Aquaphor /00298701/ (Unk)
  • Hydrocortisone (Unk)
  • Vicodin (500 Mg, Unk)
  • Zofran /00955301/ (8 Mg, Unk)
  • Phenergan /00033001/ (25 Mg, Unk)
  • Emla /00675501/ (2.5 Mg, Unk)
  • Lopressor (25 Mg, Unk)
  • Calcium (500 Mg, Unk)
Although Prozac demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as osteonecrosis of jaw, may still occur.

Breast Cancer, Bone Disorder
This Breast Cancer, Bone Disorder problem was reported by a consumer or non-health professional from CA. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Oct 09, 2013 this consumer started treatment with Prozac (dosage: 40 Mg, Qd). The following drugs were being taken at the same time:
  • Tamoxifen (20 Mg, Qd)
When commencing Prozac, the patient experienced the following unwanted symptoms/side effects:
  • Breast Cancer
  • Bone Disorder
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as breast cancer, may become evident only after a product is in use by the general population.

Compression Fracture, Local Swelling, Pain In Extremity, Back Pain, Chest Pain, Dyspnoea, Contusion
This is a report of a 52-year-old female patient (weight: NA) from COUNTRY NOT SPECIFIED. The patient developed the following symptoms/conditions: depression,pain,asthma and was treated with Prozac (dosage: NA) starting 201212. Concurrently used drugs:
  • Naproxen
  • Advair
  • Albuterol (Rescue Inhaler)
  • Lidoderm (Patch)
  • Fosamax
  • Nexium
  • Humira
  • Cozaar
Soon after that, the consumer experienced the following side effects:
  • Compression Fracture
  • Local Swelling
  • Pain In Extremity
  • Back Pain
  • Chest Pain
  • Dyspnoea
  • Contusion
This opens a possibility that Prozac treatment could cause the above reactions, including compression fracture, and some female subjects may be more susceptible.


Glaucoma
A 71-year-old female patient (weight: NA) from NZ with the following symptoms/conditions: depression started Prozac treatment (dosage: 40 Mg, Qd) on Apr 08, 2013. Soon after starting Prozac treatment, the subject experienced various side effects, including:
  • Glaucoma
Concurrently used drugs:
  • Quetiapine (50 Mg, Qd)
  • Atorvastatin (80 Mg, Qd)
  • Fluticasone (250 Ug, Qd)
  • Amlodipine (5 Mg, Qd)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Prozac.

Parkinsonism, Muscle Rigidity, Tremor, Malaise
A 84-year-old male patient from FR (weight: NA) experienced symptoms, such as: depression and was treated with Prozac(dosage: 10 Mg, Qd). The treatment was initiated on Dec 12, 2013. After that a consumer reported the following side effect(s):
  • Parkinsonism
  • Muscle Rigidity
  • Tremor
  • Malaise
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Prozac efficacy:
  • Kardegic
  • Befizal
The patient was hospitalized.

Anxiety, Hallucination, Dizziness
In this report, Prozac was administered for the following condition: NA.A 13-year-old male consumer from US (weight: NA) started Prozac treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Anxiety
  • Hallucination
  • Dizziness
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized and became disabled.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Prozac treatment could be related to the listed above side effect(s).

Blood Calcium Increased
This is a report of the following Prozac side effect(s):
  • Blood Calcium Increased
A 43-year-old female patient from GB (weight: NA) presented with the following condition: depression and received a treatment with Prozac (dosage: 20 Mg, Qd) starting: Jan 16, 2014.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Prozac treatment could be associated with the listed above side effect(s).

Psychomotor Retardation, Confusional State, Pneumonia Aspiration, C-reactive Protein Increased, Meningeal Disorder, Tachycardia, Hyponatraemia
This Prozac report was submitted by a 68-year-old male consumer from FR (weight: NA). The patient was diagnosed with: NA and Prozac was administered (dosage: 20 Mg, Qd) starting: Nov 27, 2013. The consumer developed a set of symptoms:
  • Psychomotor Retardation
  • Confusional State
  • Pneumonia Aspiration
  • C-reactive Protein Increased
  • Meningeal Disorder
  • Tachycardia
  • Hyponatraemia
Other drugs used simultaneously:
  • Risperdal (2 Mg, Qd)
  • Haldol Decanoas (4 Mg, Qd)
  • Stilnox
  • Abilify (Unk)
  • Depamide (Unk)
The patient was hospitalized.Those unexpected symptoms could be linked to a Prozac treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Poisoning, Suicidal Ideation, Pressure Of Speech, Clumsiness, Irritability, Euphoric Mood, Lethargy
This is a report of a possible correlation between Prozac use and the following symptoms/side effect(s):
  • Poisoning
  • Suicidal Ideation
  • Pressure Of Speech
  • Clumsiness
  • Irritability
  • Euphoric Mood
  • Lethargy
which could contribute to an assessment of Prozac risk profile.A 30-year-old male consumer from US (weight: NA) was suffering from depression and was treated with Prozac (dosage: 20 Mg, Each Morning) starting NS.Other concurrent medications:
  • Trazodone (50 Mg, Each Evening)
  • Trazodone (250 Mg, Each Evening)
  • Disulfiram (500 Mg, Qd)
  • Diazepam
The patient was hospitalized.

Energy Increased, Logorrhoea, Hypoaesthesia, Feeling Of Relaxation, Weight Increased, Feeling Jittery, Elevated Mood
A 35-year-old female patient from US (weight: NA) presented with the following symptoms: depression and after a treatment with Prozac (dosage: 40 Mg, Each Morning) experienced the following side effect(s):
  • Energy Increased
  • Logorrhoea
  • Hypoaesthesia
  • Feeling Of Relaxation
  • Weight Increased
  • Feeling Jittery
  • Elevated Mood
The treatment was started on NS. Prozac was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Prozac consumers.

Haemorrhagic Anaemia, Gastrointestinal Haemorrhage, Dyspnoea, Gastric Ulcer
In this report, a 50-year-old female patient from FR (weight: NA) was affected by a possible Prozac side effect.The patient was diagnosed with NA. After a treatment with Prozac (dosage: 20 Mg, Qd, start date: 2012), the patient experienced the following side effect(s):
  • Haemorrhagic Anaemia
  • Gastrointestinal Haemorrhage
  • Dyspnoea
  • Gastric Ulcer
The following simultaneously used drugs could have led to this reaction:
  • Xarelto (15 Mg, Bid)
  • Duoplavin (75 Mg, Qd)
  • Humalog
  • Lantus
  • Glucophage (1000 Mg, Bid)
  • Coversyl (10 Mg, Qd)
  • Sectral (200 Mg, Qd)
  • Inegy (40 Mg, Qd)
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Prozac treatment.

Autoimmune Thyroiditis
This is a report of a 30-year-old female patient from IE (weight: NA), who used Prozac (dosage: 20 Mg, Qd) for a treatment of depressed mood,psychotic disorder. After starting a treatment on Dec 09, 2013, the patient experienced the following side effect(s):
  • Autoimmune Thyroiditis
The following drugs could possibly have interacted with the Prozac treatment
  • Risperdal (3 Mg, Qd)
  • Risperdal (1 Mg, Unk)
Taken together, these observations suggest that a Prozac treatment could be related to side effect(s), such as Autoimmune Thyroiditis.

Ventricular Tachycardia, Torsade De Pointes, Hypotension, Syncope
This ventricular tachycardia side effect was reported by a physician from US. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression. The patient was prescribed Prozac (dosage: 20 Mg, Daily (1/d)), which was started on 199303. Concurrently used drugs:
  • Amitriptyline
When starting to take Prozac the consumer reported the following symptoms:
  • Ventricular Tachycardia
  • Torsade De Pointes
  • Hypotension
  • Syncope
The patient was hospitalized. These side effects may potentially be related to Prozac.

Intentional Self-injury, Condition Aggravated, Irritability, Aggression, Anger, Insomnia
This is a Prozac side effect report of a 12-year-old male patient (weight:NA) from FR, suffering from the following symptoms/conditions: depression, who was treated with Prozac (dosage:10 Mg, Qd, start time: 201312), combined with:
  • Atarax /00595201/
, and developed a serious reaction and a intentional self-injury side effect. The patient presented with:
  • Intentional Self-injury
  • Condition Aggravated
  • Irritability
  • Aggression
  • Anger
  • Insomnia
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Prozac treatment in male patients suffering from depression, resulting in intentional self-injury.

Colitis Microscopic, Diarrhoea, Clostridium Test Positive, Abdominal Pain, Proctitis, Weight Decreased
This report suggests a potential Prozac colitis microscopic side effect(s) that can have serious consequences. A 56-year-old female patient from FR (weight:NA) was diagnosed with the following health condition(s): NA and used Prozac (dosage: NA) starting 201306. Soon after starting Prozac the patient began experiencing various side effects, including:
  • Colitis Microscopic
  • Diarrhoea
  • Clostridium Test Positive
  • Abdominal Pain
  • Proctitis
  • Weight Decreased
Drugs used concurrently:
  • Mopral /00661201/
  • Spifen
  • Ixprim
The patient was hospitalized. Although Prozac demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as colitis microscopic, may still occur.

Craniocerebral Injury, Subdural Haematoma, Wrist Fracture, Fall
This craniocerebral injury problem was reported by a consumer or non-health professional from FR. A 83-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): depression.On 201307 a consumer started treatment with Prozac (dosage: 20 Mg, Qd). The following drugs/medications were being taken at the same time:
  • Singulair
  • Flecaine
  • Ogast
  • Stilnox
When commencing Prozac, the patient experienced the following unwanted symptoms /side effects:
  • Craniocerebral Injury
  • Subdural Haematoma
  • Wrist Fracture
  • Fall
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as craniocerebral injury, may become evident only after a product is in use by the general population.

Alcohol Withdrawal Syndrome
This is a Prozac side effect report of a 71-year-old male patient (weight: NA) from FR. The patient developed the following symptoms/conditions: NA and was treated with Prozac (dosage: NA) starting 201303. Concurrently used drugs:
  • Baclofene Irex (4 Df, Tid)
  • Adancor
  • Plavix
  • Allopurinol
  • Bi Tildiem
  • Tahor
  • Inexium /01479302/
  • Zopiclone
Soon after that, the consumer experienced the following of symptoms:
  • Alcohol Withdrawal Syndrome
This opens a possibility that Prozac could cause sudden death and that some male patients may be more susceptible.

Acute Respiratory Distress Syndrome, Interstitial Lung Disease, Dyspnoea, Lung Disorder, Eosinophilia, Adenocarcinoma Of Colon, Peritonitis, Septic Shock, Dyspnoea Exertional
A 65-year-old female patient (weight: NA) from FR with the following symptoms: NA started Prozac treatment (dosage: 2 Df, Qd) on 201302. Soon after starting Prozac treatment, the consumer experienced several side effects, including:
  • Acute Respiratory Distress Syndrome
  • Interstitial Lung Disease
  • Dyspnoea
  • Lung Disorder
  • Eosinophilia
  • Adenocarcinoma Of Colon
  • Peritonitis
  • Septic Shock
  • Dyspnoea Exertional
. Concurrently used drugs:
  • Effexor Lp (37.5 Mg, Bid)
  • Effexor Lp (75 Mg, Bid)
  • Depamide
  • Xanax (0.25 Mg, Bid)
  • Noctamide (1 Df, Qd)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Prozac side effects, such as acute respiratory distress syndrome.

Euphoric Mood, Feeling Abnormal, Aggression, Dissociation, Hallucination, Body Temperature Fluctuation, Pyrexia, Pain
This euphoric mood side effect was reported by a consumer or non-health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Prozac (dosage: 4 20mg Prozac 90mg Amphetamine, Prozac Qa Amp Tid, Taken By Mouth), which was started on Oct 30, 2013. Concurrently used drugs:
  • Amphetamine Salts (30mng Tid, Three Times Daily, Taken By Mouth)
.When starting to take Prozac the consumer reported symptoms, such as:
  • Euphoric Mood
  • Feeling Abnormal
  • Aggression
  • Dissociation
  • Hallucination
  • Body Temperature Fluctuation
  • Pyrexia
  • Pain
These side effects may potentially be related to Prozac.

Torsade De Pointes, Electrocardiogram Qt Prolonged, Ventricular Fibrillation, Cardiac Arrest, Sinus Tachycardia, Blood Magnesium Increased, Blood Glucose Increased, Blood Creatine Phosphokinase Increased
This is a report of a 59-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: depression,fibromyalgia, who was treated with Prozac (dosage: 30 Mg, Daily (1/d), start time: 199601), combined with:
  • Flexeril (10 Mg, Daily (1/d))
  • Amlodipine (5 Mg, Daily (1/d))
  • Diclofenac (100 Mg, Daily (1/d))
  • Hydrochlorothiazide With Triamterene (Unk, Daily (1/d))
  • Atracurium
  • Bupivacaine
  • Cefazolin (1 G, Daily (1/d))
  • Droperidol (0.625 Mg, Daily (1/d))
and developed a serious reaction and side effect(s). The consumer presented with:
  • Torsade De Pointes
  • Electrocardiogram Qt Prolonged
  • Ventricular Fibrillation
  • Cardiac Arrest
  • Sinus Tachycardia
  • Blood Magnesium Increased
  • Blood Glucose Increased
  • Blood Creatine Phosphokinase Increased
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prozac treatment in female patients, resulting in torsade de pointes side effect. The patient was hospitalized.

Torsade De Pointes, Dizziness Postural, Hot Flush
This report suggests a potential Prozac Torsade De Pointes, Dizziness Postural, Hot Flush side effect(s) that can have serious consequences. A 41-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Prozac (dosage: 20 Mg, Daily (1/d)) starting NS. Soon after starting Prozac the patient began experiencing various side effects, including:
  • Torsade De Pointes
  • Dizziness Postural
  • Hot Flush
Drugs used concurrently:
  • Methadone
  • Levomethadyl Acetate Hydrochloride (120 Mg, Other)
  • Fosamax (5 Mg, Daily (1/d))
  • Vitamin D
  • Calcium
The patient was hospitalized. Although Prozac demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as torsade de pointes, may still occur.

Torsade De Pointes, Electrocardiogram Qt Prolonged
This Torsade De Pointes, Electrocardiogram Qt Prolonged problem was reported by a pharmacist from US. A 83-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Prozac (dosage: 20 Mg, Daily (1/d)). The following drugs were being taken at the same time:
  • Acetylsalicylic Acid (30 Mg, Daily (1/d))
When commencing Prozac, the patient experienced the following unwanted symptoms/side effects:
  • Torsade De Pointes
  • Electrocardiogram Qt Prolonged
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as torsade de pointes, may become evident only after a product is in use by the general population.

Photopsia, Weight Increased, Increased Appetite
This is a report of a female patient (weight: NA) from FR. The patient developed the following symptoms/conditions: NA and was treated with Prozac (dosage: 40 Mg, Each Morning) starting 201310. Concurrently used drugs:
  • Temesta (1 Mg, Tid)
  • Atarax (50 Mg, Each Evening)
Soon after that, the consumer experienced the following side effects:
  • Photopsia
  • Weight Increased
  • Increased Appetite
This opens a possibility that Prozac treatment could cause the above reactions, including photopsia, and some female subjects may be more susceptible.

Myocardial Infarction, Dyspnoea
A 60-year-old female patient (weight: NA) from NZ with the following symptoms/conditions: NA started Prozac treatment (dosage: 1 Df, Qd) on NS. Soon after starting Prozac treatment, the subject experienced various side effects, including:
  • Myocardial Infarction
  • Dyspnoea
Concurrently used drugs:
  • Ticagrelor (180 Mg, Qd)
  • Metoprolol (1 Df, Qd)
  • Warfarin (1 Df, Each Evening)
  • Atorvastatin (1 Df, Qd)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Prozac.

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Top 10 Prozac Side Effects for Women

Women Side EffectsReports
Depression 107
Anxiety 83
Nausea 66
Suicidal Ideation 66
Feeling Abnormal 64
Headache 59
Pain 56
Vomiting 53
Dyspnoea 48
Fall 46

Top 10 Prozac Side Effects for Men

Men Side EffectsReports
Completed Suicide 48
Aggression 43
Homicide 38
Depression 33
Insomnia 31
Suicidal Ideation 30
Feeling Abnormal 28
Anxiety 27
Suicide Attempt 27
Abnormal Behaviour 25

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


    Discuss Prozac Side Effects

    Did You Have a Prozac Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Prozac for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Prozac Safety Alerts, Active Ingredients, Usage Information

    NDC0002-3004
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameProzac Weekly
    NameFluoxetine hydrochloride
    Dosage FormCAPSULE, DELAYED RELEASE
    RouteORAL
    On market since20010316
    LabelerEli Lilly and Company
    Active Ingredient(s)FLUOXETINE HYDROCHLORIDE
    Strength(s)90
    Unit(s)mg/1
    Pharma ClassSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

    Prozac Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1954

    Prozac safety alerts: 2005

    Reported deaths: 267

    Reported hospitalizations: 828

    Prozac (fluoxetine)

    Audience: Neuropsychiatric healthcare professionals and consumers

    [UPDATE 07/08/2005] FDA notified healthcare professionals about the availability of updated Healthcare Professional and Patient Information Sheets for antidepressant medications that were the subject of a June 30, 2005 Public Health Advisory issued about the risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications.

    [Posted 07/01/2005] In response to recent scientific publications that report the possibility of increased risk of suicidal behavior in adults treated with antidepressants, the FDA has issued a Public Health Advisory to update patients and healthcare providers with the latest information on this subject. Even before the publication of these recent reports, FDA had already begun the process of reviewing available data to determine whether there is an increased risk of suicidal behavior in adults taking antidepressants. The Agency has asked manufacturers to provide information from their trials using an approach similar to that used in the evaluation of the risk of suicidal behavior in the pediatric population taking antidepressants. This effort will involve hundreds of clinical trials and may take more than a year to complete.

    [July 08, 2005 - Healthcare Professional and Patient Information Sheets - FDA]
    [June 30, 2005 - Public Health Advisory - FDA]
    [June 30, 2005 - Drug Information Page - FDA]


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