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Prozac Side Effects

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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.

Prozac Side Effects Reported to FDA



Prozac Side Effect Report#9960293
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 health 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): Cardiogenic Shock, Hypothermia, Hypotension, Bradycardia, Electrocardiogram Qt Prolonged, Overdose 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.
Prozac Side Effect Report#9956378
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. After starting Prozac the patient began experiencing various side effects, including: Osteonecrosis Of JawAdditional 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.
Prozac Side Effect Report#9955199
Breast Cancer, Bone Disorder
This Breast Cancer 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 using Prozac, the patient experienced the following unwanted symptoms/side effects: Breast Cancer, Bone DisorderAlthough 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.
Prozac Side Effect Report#9954456
Compression Fracture, Local Swelling, Pain In Extremity, Back Pain, Chest Pain, Chest Pain, Dyspnoea, Contusion
This Compression Fracture side effect was reported by a consumer or non-health professional from Country Not Specified. A 52-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression,pain,asthma.The patient was prescribed Prozac (drug dosage: NA), which was initiated on 201212. Concurrently used drugs:
  • Naproxen
  • Advair
  • Albuterol (Rescue Inhaler)
  • Lidoderm (Patch)
  • Fosamax
  • Nexium
  • Humira
  • Cozaar
.After starting to take Prozac the consumer reported adverse symptoms, such as: Compression Fracture, Local Swelling, Pain In Extremity, Back Pain, Chest Pain, Chest Pain, Dyspnoea, ContusionThese side effects may potentially be related to Prozac.
Prozac Side Effect Report#9914657
Glaucoma
This is a report of a 71-year-old female patient (weight: NA) from NZ, suffering from the following health symptoms/conditions: depression, who was treated with Prozac (dosage: 40 Mg, Qd, start time:
Apr 08, 2013), combined with:
  • Quetiapine (50 Mg, Qd)
  • Atorvastatin (80 Mg, Qd)
  • Fluticasone (250 Ug, Qd)
  • Amlodipine (5 Mg, Qd)
and developed a serious reaction and side effect(s): Glaucoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prozac treatment in female patients, resulting in Glaucoma side effect. The patient was hospitalized.
Prozac Side Effect Report#9914364
Parkinsonism, Muscle Rigidity, Tremor, Malaise
This report suggests a potential Prozac Parkinsonism side effect(s) that can have serious consequences. A 84-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: depression and used Prozac (dosage: 10 Mg, Qd) starting
Dec 12, 2013. After starting Prozac the patient began experiencing various side effects, including: Parkinsonism, Muscle Rigidity, Tremor, MalaiseAdditional drugs used concurrently:
  • Kardegic
  • Befizal
The patient was hospitalized. Although Prozac demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Parkinsonism, may still occur.
Prozac Side Effect Report#9891252
Anxiety, Hallucination, Dizziness
This Anxiety problem was reported by a consumer or non-health professional from US. A 13-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Prozac (dosage: NA). The following drugs were being taken at the same time: NA. When using Prozac, the patient experienced the following unwanted symptoms/side effects: Anxiety, Hallucination, DizzinessThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anxiety, may become evident only after a product is in use by the general population.
Prozac Side Effect Report#9883836
Blood Calcium Increased
This Blood Calcium Increased side effect was reported by a pharmacist from GB. A 43-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression.The patient was prescribed Prozac (drug dosage: 20 Mg, Qd), which was initiated on
Jan 16, 2014. Concurrently used drugs: NA..After starting to take Prozac the consumer reported adverse symptoms, such as: Blood Calcium IncreasedThese side effects may potentially be related to Prozac.
Prozac Side Effect Report#9869384
Psychomotor Retardation, Confusional State, Pneumonia Aspiration, C-reactive Protein Increased, Meningeal Disorder, Tachycardia, Hyponatraemia
This is a report of a 68-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Prozac (dosage: 20 Mg, Qd, start time:
Nov 27, 2013), combined with:
  • Risperdal (2 Mg, Qd)
  • Haldol Decanoas (4 Mg, Qd)
  • Stilnox
  • Abilify (Unk)
  • Depamide (Unk)
and developed a serious reaction and side effect(s): Psychomotor Retardation, Confusional State, Pneumonia Aspiration, C-reactive Protein Increased, Meningeal Disorder, Tachycardia, Hyponatraemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prozac treatment in male patients, resulting in Psychomotor Retardation side effect. The patient was hospitalized.
Prozac Side Effect Report#9831794
Poisoning, Suicidal Ideation, Pressure Of Speech, Clumsiness, Irritability, Euphoric Mood, Lethargy
This report suggests a potential Prozac Poisoning side effect(s) that can have serious consequences. A 30-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: depression and used Prozac (dosage: 20 Mg, Each Morning) starting NS. After starting Prozac the patient began experiencing various side effects, including: Poisoning, Suicidal Ideation, Pressure Of Speech, Clumsiness, Irritability, Euphoric Mood, LethargyAdditional drugs used concurrently:
  • Trazodone (50 Mg, Each Evening)
  • Trazodone (250 Mg, Each Evening)
  • Disulfiram (500 Mg, Qd)
  • Diazepam
The patient was hospitalized. Although Prozac demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning, may still occur.
Prozac Side Effect Report#9830757
Energy Increased, Logorrhoea, Hypoaesthesia, Feeling Of Relaxation, Weight Increased, Feeling Jittery, Elevated Mood
This Energy Increased problem was reported by a physician from US. A 35-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On NS this consumer started treatment with Prozac (dosage: 40 Mg, Each Morning). The following drugs were being taken at the same time: NA. When using Prozac, the patient experienced the following unwanted symptoms/side effects: Energy Increased, Logorrhoea, Hypoaesthesia, Feeling Of Relaxation, Weight Increased, Feeling Jittery, Elevated MoodThe 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 Energy Increased, may become evident only after a product is in use by the general population.
Prozac Side Effect Report#9830756
Haemorrhagic Anaemia, Gastrointestinal Haemorrhage, Dyspnoea, Gastric Ulcer
This Haemorrhagic Anaemia side effect was reported by a consumer or non-health professional from FR. A 50-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Prozac (drug dosage: 20 Mg, Qd), which was initiated on 2012. Concurrently used drugs:
  • 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)
.After starting to take Prozac the consumer reported adverse symptoms, such as: Haemorrhagic Anaemia, Gastrointestinal Haemorrhage, Dyspnoea, Gastric UlcerThese side effects may potentially be related to Prozac. The patient was hospitalized.
Prozac Side Effect Report#9815620
Autoimmune Thyroiditis
This is a report of a 30-year-old female patient (weight: NA) from IE, suffering from the following health symptoms/conditions: depressed mood,psychotic disorder, who was treated with Prozac (dosage: 20 Mg, Qd, start time:
Dec 09, 2013), combined with:
  • Risperdal (3 Mg, Qd)
  • Risperdal (1 Mg, Unk)
and developed a serious reaction and side effect(s): Autoimmune Thyroiditis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prozac treatment in female patients, resulting in Autoimmune Thyroiditis side effect.
Prozac Side Effect Report#9813124
Ventricular Tachycardia, Torsade De Pointes, Hypotension, Syncope
This report suggests a potential Prozac Ventricular Tachycardia side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: depression and used Prozac (dosage: 20 Mg, Daily (1/d)) starting 199303. After starting Prozac the patient began experiencing various side effects, including: Ventricular Tachycardia, Torsade De Pointes, Hypotension, SyncopeAdditional drugs used concurrently:
  • Amitriptyline
The patient was hospitalized. Although Prozac demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Ventricular Tachycardia, may still occur.
Prozac Side Effect Report#9805561
Intentional Self-injury, Condition Aggravated, Irritability, Aggression, Anger, Insomnia
This Intentional Self-injury problem was reported by a physician from FR. A 12-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On 201312 this consumer started treatment with Prozac (dosage: 10 Mg, Qd). The following drugs were being taken at the same time:
  • Atarax /00595201/
When using Prozac, the patient experienced the following unwanted symptoms/side effects: Intentional Self-injury, Condition Aggravated, Irritability, Aggression, Anger, InsomniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Intentional Self-injury, may become evident only after a product is in use by the general population.
Prozac Side Effect Report#9805552
Colitis Microscopic, Diarrhoea, Clostridium Test Positive, Abdominal Pain, Proctitis, Weight Decreased
This Colitis Microscopic side effect was reported by a consumer or non-health professional from FR. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Prozac (drug dosage: NA), which was initiated on 201306. Concurrently used drugs:
  • Mopral /00661201/
  • Spifen
  • Ixprim
.After starting to take Prozac the consumer reported adverse symptoms, such as: Colitis Microscopic, Diarrhoea, Clostridium Test Positive, Abdominal Pain, Proctitis, Weight DecreasedThese side effects may potentially be related to Prozac. The patient was hospitalized.
Prozac Side Effect Report#9788290
Craniocerebral Injury, Subdural Haematoma, Wrist Fracture, Fall, Fall
This is a report of a 83-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: depression, who was treated with Prozac (dosage: 20 Mg, Qd, start time: 201307), combined with:
  • Singulair
  • Flecaine
  • Ogast
  • Stilnox
and developed a serious reaction and side effect(s): Craniocerebral Injury, Subdural Haematoma, Wrist Fracture, Fall, Fall after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prozac treatment in female patients, resulting in Craniocerebral Injury side effect. The patient was hospitalized.
Prozac Side Effect Report#9780799
Alcohol Withdrawal Syndrome
This report suggests a potential Prozac Sudden Death side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Prozac (dosage: NA) starting 201303. After starting Prozac the patient began experiencing various side effects, including: Alcohol Withdrawal SyndromeAdditional drugs used concurrently:
  • Baclofene Irex (4 Df, Tid)
  • Adancor
  • Plavix
  • Allopurinol
  • Bi Tildiem
  • Tahor
  • Inexium /01479302/
  • Zopiclone
Although Prozac demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sudden Death, may still occur.
Prozac Side Effect Report#9759168
Acute Respiratory Distress Syndrome, Interstitial Lung Disease, Dyspnoea, Lung Disorder, Eosinophilia, Adenocarcinoma Of Colon, Peritonitis, Septic Shock, Dyspnoea Exertional
This Acute Respiratory Distress Syndrome problem was reported by a consumer or non-health professional from FR. A 65-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201302 this consumer started treatment with Prozac (dosage: 2 Df, Qd). The following drugs were being taken at the same time:
  • Effexor Lp (37.5 Mg, Bid)
  • Effexor Lp (75 Mg, Bid)
  • Depamide
  • Xanax (0.25 Mg, Bid)
  • Noctamide (1 Df, Qd)
When using Prozac, the patient experienced the following unwanted symptoms/side effects: Acute Respiratory Distress Syndrome, Interstitial Lung Disease, Dyspnoea, Lung Disorder, Eosinophilia, Adenocarcinoma Of Colon, Peritonitis, Septic Shock, Dyspnoea ExertionalThe 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 Acute Respiratory Distress Syndrome, may become evident only after a product is in use by the general population.
Prozac Side Effect Report#9746251
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 (drug dosage: 4 20mg Prozac 90mg Amphetamine, Prozac Qa Amp Tid, Taken By Mouth), which was initiated on
Oct 30, 2013. Concurrently used drugs:
  • Amphetamine Salts (30mng Tid, Three Times Daily, Taken By Mouth)
.After starting to take Prozac the consumer reported adverse symptoms, such as: Euphoric Mood, Feeling Abnormal, Aggression, Dissociation, Hallucination, Body Temperature Fluctuation, Pyrexia, PainThese side effects may potentially be related to Prozac.
Prozac Side Effect Report#9742919
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 health 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): Torsade De Pointes, Electrocardiogram Qt Prolonged, Ventricular Fibrillation, Cardiac Arrest, Sinus Tachycardia, Blood Magnesium Increased, Blood Glucose Increased, Blood Creatine Phosphokinase Increased 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.
Prozac Side Effect Report#9742918
Torsade De Pointes, Dizziness Postural, Hot Flush
This report suggests a potential Prozac Torsade De Pointes 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. After starting Prozac the patient began experiencing various side effects, including: Torsade De Pointes, Dizziness Postural, Hot FlushAdditional 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.
Prozac Side Effect Report#9742916
Torsade De Pointes, Electrocardiogram Qt Prolonged
This Torsade De Pointes 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 using Prozac, the patient experienced the following unwanted symptoms/side effects: Torsade De Pointes, Electrocardiogram Qt ProlongedThe 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.
Prozac Side Effect Report#9739293
Photopsia, Weight Increased, Increased Appetite
This Photopsia side effect was reported by a consumer or non-health professional from FR. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Prozac (drug dosage: 40 Mg, Each Morning), which was initiated on 201310. Concurrently used drugs:
  • Temesta (1 Mg, Tid)
  • Atarax (50 Mg, Each Evening)
.After starting to take Prozac the consumer reported adverse symptoms, such as: Photopsia, Weight Increased, Increased AppetiteThese side effects may potentially be related to Prozac.
Prozac Side Effect Report#9729155
Myocardial Infarction, Dyspnoea
This is a report of a 60-year-old female patient (weight: NA) from NZ, suffering from the following health symptoms/conditions: NA, who was treated with Prozac (dosage: 1 Df, Qd, start time: NS), combined with:
  • Ticagrelor (180 Mg, Qd)
  • Metoprolol (1 Df, Qd)
  • Warfarin (1 Df, Each Evening)
  • Atorvastatin (1 Df, Qd)
and developed a serious reaction and side effect(s): Myocardial Infarction, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prozac treatment in female patients, resulting in Myocardial Infarction side effect. The patient was hospitalized.


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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.

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What are common 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

What are common 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

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

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    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
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    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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