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Common Fluoxetine Side Effects


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

Completed Suicide (346)
Depression (233)
Anxiety (191)
Suicidal Ideation (178)
Serotonin Syndrome (164)
Agitation (160)
Confusional State (159)
Condition Aggravated (149)
Cardiac Arrest (148)
Death (143)
Nausea (141)
Toxicity To Various Agents (140)
Headache (139)
Fatigue (127)
Dizziness (121)
Feeling Abnormal (114)
Respiratory Arrest (111)
Poisoning (110)
Tremor (108)
Insomnia (104)

➢ 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.

Fluoxetine Side Effects Reported to FDA



Fluoxetine Side Effect Report#9998225
Asthenia, Somnolence
This is a report of a 39-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Fluoxetine Hydrochloride (dosage: 1.8 Mg Total, start time:
Feb 18, 2014), combined with: NA. and developed a serious reaction and side effect(s): Asthenia, Somnolence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluoxetine Hydrochloride treatment in female patients, resulting in Asthenia side effect. The patient was hospitalized.
Fluoxetine Side Effect Report#9994769
Treatment Failure, Product Substitution Issue
This report suggests a potential Fluoxetine Treatment Failure side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: depression,anxiety and used Fluoxetine (dosage: 20 Mg 1 Tablet Three Times Daily) starting NS. After starting Fluoxetine the patient began experiencing various side effects, including: Treatment Failure, Product Substitution IssueAdditional drugs used concurrently: NA. Although Fluoxetine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Treatment Failure, may still occur.
Fluoxetine Side Effect Report#9990374
Serotonin Syndrome, Tremor, Dyskinesia, Mydriasis, Hyperventilation, Feeling Abnormal
This Serotonin Syndrome problem was reported by a physician from GB. A 15-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On
Feb 07, 2014 this consumer started treatment with Fluoxetine (dosage: NA). The following drugs were being taken at the same time: NA. When using Fluoxetine, the patient experienced the following unwanted symptoms/side effects: Serotonin Syndrome, Tremor, Dyskinesia, Mydriasis, Hyperventilation, Feeling AbnormalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Serotonin Syndrome, may become evident only after a product is in use by the general population.
Fluoxetine Side Effect Report#9989189
Diplopia
This Diplopia side effect was reported by a consumer or non-health professional from GB. A 44-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fluoxetine (drug dosage: NA), which was initiated on
Nov 26, 2013. Concurrently used drugs: NA..After starting to take Fluoxetine the consumer reported adverse symptoms, such as: DiplopiaThese side effects may potentially be related to Fluoxetine.
Fluoxetine Side Effect Report#9988849
Foot Fracture
This is a report of a 49-year-old female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: fibromyalgia,multiple sclerosis, who was treated with Fluoxetine (dosage: Daily Dose: 40 Mg Millgram(s) Every Days, start time: 2010), combined with:
  • Fingolimod (Daily Dose: 0.5 Mg Millgram(s) Every Days)
and developed a serious reaction and side effect(s): Foot Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluoxetine treatment in female patients, resulting in Foot Fracture side effect.
Fluoxetine Side Effect Report#9988647
Hypertension, Muscular Weakness, Hypoaesthesia, Pain In Extremity
This report suggests a potential Fluoxetine Hypertension side effect(s) that can have serious consequences. A 30-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Fluoxetine (dosage: NA) starting
Jul 02, 2005. After starting Fluoxetine the patient began experiencing various side effects, including: Hypertension, Muscular Weakness, Hypoaesthesia, Pain In ExtremityAdditional drugs used concurrently:
  • Tramadol
  • Buscopan
  • Merbentyl
  • Paracetamol
  • Salbutamol
  • Seretide
The patient was hospitalized. Although Fluoxetine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypertension, may still occur.
Fluoxetine Side Effect Report#9988635
Diplopia
This Diplopia problem was reported by a health professional from GB. A 44-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 26, 2013 this consumer started treatment with Fluoxetine (dosage: Unk). The following drugs were being taken at the same time: NA. When using Fluoxetine, the patient experienced the following unwanted symptoms/side effects: DiplopiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diplopia, may become evident only after a product is in use by the general population.
Fluoxetine Side Effect Report#9980705
Foot Fracture
This Foot Fracture side effect was reported by a health professional from DE. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: fibromyalgia,multiple sclerosis.The patient was prescribed Fluoxetine (drug dosage: 40 Mg, Qd), which was initiated on 2010. Concurrently used drugs:
  • Fingolimod (0.5 Mg, Qd)
.After starting to take Fluoxetine the consumer reported adverse symptoms, such as: Foot FractureThese side effects may potentially be related to Fluoxetine.
Fluoxetine Side Effect Report#9948895
Spinal Subdural Haematoma
This is a report of a 73-year-old male patient (weight: NA) from NZ, suffering from the following health symptoms/conditions: depression,atrial fibrillation, who was treated with Fluoxetine (dosage: Unk, start time: NS), combined with:
  • Warfarin (Unk)
  • Candesartan (Unk)
  • Metoprolol (Unk)
  • Simvastatin (Unk)
  • Ezetimibe (Unk)
and developed a serious reaction and side effect(s): Spinal Subdural Haematoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluoxetine treatment in male patients, resulting in Spinal Subdural Haematoma side effect. The patient was hospitalized and became disabled.
Fluoxetine Side Effect Report#9941001
Suicide Attempt, Asthenia, Somnolence, Intentional Overdose
This report suggests a potential Fluoxetine Hydrochloride Suicide Attempt side effect(s) that can have serious consequences. A 39-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: depression and used Fluoxetine Hydrochloride (dosage: NA) starting
Feb 18, 2014. After starting Fluoxetine Hydrochloride the patient began experiencing various side effects, including: Suicide Attempt, Asthenia, Somnolence, Intentional OverdoseAdditional drugs used concurrently: NA.The patient was hospitalized. Although Fluoxetine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicide Attempt, may still occur.
Fluoxetine Side Effect Report#9938442
Foot Fracture, Off Label Use
This Foot Fracture problem was reported by a consumer or non-health professional from DE. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: fibromyalgia,multiple sclerosis. On 2010 this consumer started treatment with Fluoxetine Hydrochloride (dosage: 40 Mg, Qd). The following drugs were being taken at the same time:
  • Fingolimod (0.5 Mg, Qd)
When using Fluoxetine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Foot Fracture, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Foot Fracture, may become evident only after a product is in use by the general population.
Fluoxetine Side Effect Report#9938122
Diplopia
This Diplopia side effect was reported by a physician from GB. A 44-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fluoxetine (drug dosage: NA), which was initiated on
Nov 26, 2013. Concurrently used drugs: NA..After starting to take Fluoxetine the consumer reported adverse symptoms, such as: DiplopiaThese side effects may potentially be related to Fluoxetine.
Fluoxetine Side Effect Report#9931879
Dry Mouth, Gastrooesophageal Reflux Disease
This is a report of a 32-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: depression, who was treated with Fluoxetine Hcl - Discontinued Brand (dosage: NA, start time:
Nov 05, 2013), combined with:
  • Risperidone
  • Sertaline
  • Lamictal
  • Omeprazole
and developed a serious reaction and side effect(s): Dry Mouth, Gastrooesophageal Reflux Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluoxetine Hcl - Discontinued Brand treatment in male patients, resulting in Dry Mouth side effect.
Fluoxetine Side Effect Report#9929298
Vasoplegia Syndrome, Metabolic Acidosis, Hyperdynamic Left Ventricle, Coma, Electrocardiogram Qt Prolonged, Hypotension, Overdose
This report suggests a potential Fluoxetine Vasoplegia Syndrome side effect(s) that can have serious consequences. A 41-year-old male patient (weight: NA) from AU was diagnosed with the following symptoms/conditions: NA and used Fluoxetine (dosage: 240 Mg, Single) starting NS. After starting Fluoxetine the patient began experiencing various side effects, including: Vasoplegia Syndrome, Metabolic Acidosis, Hyperdynamic Left Ventricle, Coma, Electrocardiogram Qt Prolonged, Hypotension, OverdoseAdditional drugs used concurrently:
  • Carbamazepine
  • Epinephrine (100 Mg, Single)
  • Oxazepam
  • Quetiapine
  • Sodium Valproate
Although Fluoxetine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vasoplegia Syndrome, may still occur.
Fluoxetine Side Effect Report#9928906
Toxicity To Various Agents, Distributive Shock, Metabolic Acidosis, Pneumonia Aspiration, Exposure Via Ingestion
This Toxicity To Various Agents problem was reported by a physician from AU. A 41-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Fluoxetine (dosage: NA). The following drugs were being taken at the same time:
  • Quetiapine
  • Carbamazepine
  • Sodium Valproate
  • Oxazepam
When using Fluoxetine, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Distributive Shock, Metabolic Acidosis, Pneumonia Aspiration, Exposure Via IngestionThe 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 Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Fluoxetine Side Effect Report#9928829
Serotonin Syndrome
This Serotonin Syndrome side effect was reported by a health professional from IN. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fluoxetine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Tramadol/acetaminophen
  • Ondansetron
.After starting to take Fluoxetine the consumer reported adverse symptoms, such as: Serotonin SyndromeThese side effects may potentially be related to Fluoxetine.
Fluoxetine Side Effect Report#9928810
Syncope, Electrocardiogram Qt Prolonged, Torsade De Pointes, Ventricular Fibrillation
This is a report of a 62-year-old female patient (weight: NA) from NL, suffering from the following health symptoms/conditions: NA, who was treated with Fluoxetine (dosage: 20 Mg; Qd;, start time: NS), combined with:
  • Codeine (15 Mg; Qd;)
  • Tramadol (100 Mg; Qd;)
and developed a serious reaction and side effect(s): Syncope, Electrocardiogram Qt Prolonged, Torsade De Pointes, Ventricular Fibrillation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluoxetine treatment in female patients, resulting in Syncope side effect. The patient was hospitalized.
Fluoxetine Side Effect Report#9924834
Gastrooesophageal Reflux Disease
This report suggests a potential Fluoxetine Gastrooesophageal Reflux Disease side effect(s) that can have serious consequences. A 50-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: depression and used Fluoxetine (dosage: NA) starting NS. After starting Fluoxetine the patient began experiencing various side effects, including: Gastrooesophageal Reflux DiseaseAdditional drugs used concurrently: NA. Although Fluoxetine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gastrooesophageal Reflux Disease, may still occur.
Fluoxetine Side Effect Report#9924379
Fatigue, Suicidal Ideation, Headache
This Fatigue problem was reported by a consumer or non-health professional from GB. A 18-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On
Oct 19, 2013 this consumer started treatment with Fluoxetine (dosage: NA). The following drugs were being taken at the same time: NA. When using Fluoxetine, the patient experienced the following unwanted symptoms/side effects: Fatigue, Suicidal Ideation, HeadacheAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Fatigue, may become evident only after a product is in use by the general population.
Fluoxetine Side Effect Report#9924370
Renal Failure Acute, Agitation, Alanine Aminotransferase Increased, Faecal Incontinence, Confusional State, Coma Scale Abnormal, Blood Cholesterol Increased, Dysarthria, Dehydration
This Renal Failure Acute side effect was reported by a pharmacist from GB. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fluoxetine (drug dosage: NA), which was initiated on
Mar 04, 2013. Concurrently used drugs:
  • Clopidogrel
  • Olanzapine
  • Bisoprolol
  • Aspirin
  • Furosemide
  • Ibuprofen
  • Paracetamol
  • Ramipril
.After starting to take Fluoxetine the consumer reported adverse symptoms, such as: Renal Failure Acute, Agitation, Alanine Aminotransferase Increased, Faecal Incontinence, Confusional State, Coma Scale Abnormal, Blood Cholesterol Increased, Dysarthria, DehydrationThese side effects may potentially be related to Fluoxetine. The patient was hospitalized.
Fluoxetine Side Effect Report#9922350
Dyspepsia, Product Taste Abnormal, Abdominal Discomfort, Product Taste Abnormal, Fear Of Disease
This is a report of a 26-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: obsessive-compulsive disorder, who was treated with Fluoxetine (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dyspepsia, Product Taste Abnormal, Abdominal Discomfort, Product Taste Abnormal, Fear Of Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluoxetine treatment in female patients, resulting in Dyspepsia side effect.
Fluoxetine Side Effect Report#9921934
Product Substitution Issue, Depression, Disease Recurrence, Product Quality Issue
This report suggests a potential Fluoxetine 20mg Product Substitution Issue side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: depression and used Fluoxetine 20mg (dosage: NA) starting
Feb 01, 2014. After starting Fluoxetine 20mg the patient began experiencing various side effects, including: Product Substitution Issue, Depression, Disease Recurrence, Product Quality IssueAdditional drugs used concurrently: NA. Although Fluoxetine 20mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Substitution Issue, may still occur.
Fluoxetine Side Effect Report#9921831
Abdominal Pain Upper
This Abdominal Pain Upper problem was reported by a physician from IT. A 14-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 04, 2013 this consumer started treatment with Fluoxetine Hydrochloride (dosage: 80 Mg Total). The following drugs were being taken at the same time:
  • Buscopan (30 Mg Total)
  • Zoloft (200 Mg Total)
When using Fluoxetine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Abdominal Pain UpperAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Pain Upper, may become evident only after a product is in use by the general population.
Fluoxetine Side Effect Report#9918768
This Death side effect was reported by a physician from US. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fluoxetine Hydrochloride (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Fentanyl
  • Tramadol
  • Alprazolam
  • Clonazepam
  • Trazodone
  • Amitriptyline
  • Ethanol
.After starting to take Fluoxetine Hydrochloride the consumer reported adverse symptoms, such as: These side effects may potentially be related to Fluoxetine Hydrochloride.
Fluoxetine Side Effect Report#9918767
Suicide Attempt, Spinal Fracture, Foot Fracture
This is a report of a 17-year-old male patient (weight: NA) from NL, suffering from the following health symptoms/conditions: depression suicidal, who was treated with Fluoxetine Hydrochloride (dosage: 20 Mg, Qd, start time:
Jan 09, 2013), combined with: NA. and developed a serious reaction and side effect(s): Suicide Attempt, Spinal Fracture, Foot Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fluoxetine Hydrochloride treatment in male patients, resulting in Suicide Attempt side effect. The patient was hospitalized.


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The appearance of Fluoxetine 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.

What are common Fluoxetine Side Effects for Women?

Women Side Effects Reports
Completed Suicide 167
Depression 156
Anxiety 116
Headache 114
Nausea 107
Confusional State 106
Suicidal Ideation 105
Serotonin Syndrome 88
Agitation 86
Feeling Abnormal 85

What are common Fluoxetine Side Effects for Men?

Men Side Effects Reports
Completed Suicide 115
Serotonin Syndrome 76
Depression 75
Agitation 73
Anxiety 70
Condition Aggravated 68
Suicidal Ideation 67
Death 58
Toxicity To Various Agents 57
Insomnia 55

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.

    Fluoxetine 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.

    Discuss Fluoxetine Side Effects

    Did You Have a Fluoxetine Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Fluoxetine for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Fluoxetine Safety Alerts, Active Ingredients, Usage Information

    NDC 0093-4346
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Fluoxetine
    Name Fluoxetine Hydrochloride
    Dosage Form CAPSULE
    Route ORAL
    On market since 20120829
    Labeler Teva Pharmaceuticals USA Inc
    Active Ingredient(s) FLUOXETINE HYDROCHLORIDE
    Strength(s) 40
    Unit(s) mg/1
    Pharma Class Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

    Fluoxetine Dosage, Warnings, Usage.

    Side Effects reported to FDA: 4261

    Fluoxetine safety alerts: 2005

    Reported deaths: 709

    Reported hospitalizations: 997

    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]


    Latest Fluoxetine clinical trials