DrugCite
Search

FLUOXETINE

Adverse Events
Drug Profile
Learn More
Reference
About Results
Comments

Fluoxetine Adverse Events Reported to the FDA Over Time

How are Fluoxetine adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Fluoxetine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Fluoxetine is flagged as the suspect drug causing the adverse event.

Most Common Fluoxetine Adverse Events Reported to the FDA

What are the most common Fluoxetine adverse events reported to the FDA?

Completed Suicide
1067 (2.06%)
Drug Interaction
981 (1.89%)
Drug Exposure During Pregnancy
909 (1.75%)
Drug Ineffective
693 (1.34%)
Depression
684 (1.32%)
Suicidal Ideation
581 (1.12%)
Anxiety
532 (1.03%)
Suicide Attempt
464 (.9%)
Serotonin Syndrome
454 (.88%)
Nausea
438 (.84%)
Cardiac Arrest
434 (.84%)
Show More Show More
Vomiting
433 (.84%)
Tremor
387 (.75%)
Agitation
384 (.74%)
Insomnia
384 (.74%)
Somnolence
368 (.71%)
Overdose
364 (.7%)
Feeling Abnormal
351 (.68%)
Headache
351 (.68%)
Confusional State
335 (.65%)
Dizziness
335 (.65%)
Drug Toxicity
331 (.64%)
Condition Aggravated
322 (.62%)
Fatigue
319 (.62%)
Convulsion
301 (.58%)
Death
291 (.56%)
Respiratory Arrest
277 (.53%)
Aggression
276 (.53%)
Fall
276 (.53%)
Intentional Overdose
273 (.53%)
Dyspnoea
269 (.52%)
Diarrhoea
259 (.5%)
Weight Increased
251 (.48%)
Hyperhidrosis
244 (.47%)
Weight Decreased
236 (.46%)
Asthenia
216 (.42%)
Hyponatraemia
216 (.42%)
Loss Of Consciousness
214 (.41%)
Malaise
212 (.41%)
Abnormal Behaviour
210 (.41%)
Hypotension
206 (.4%)
Drug Withdrawal Syndrome
195 (.38%)
Irritability
193 (.37%)
Cardio-respiratory Arrest
192 (.37%)
Poisoning
185 (.36%)
Maternal Drugs Affecting Foetus
178 (.34%)
Pain
178 (.34%)
Abdominal Pain
176 (.34%)
Multiple Drug Overdose
164 (.32%)
Rash
163 (.31%)
Hypertension
162 (.31%)
Pyrexia
159 (.31%)
Constipation
154 (.3%)
Decreased Appetite
152 (.29%)
Electrocardiogram Qt Prolonged
152 (.29%)
Crying
151 (.29%)
Atrial Septal Defect
147 (.28%)
Depressed Mood
147 (.28%)
Multiple Drug Overdose Intentional
144 (.28%)
Restlessness
141 (.27%)
Anger
140 (.27%)
Blood Pressure Increased
139 (.27%)
Syncope
138 (.27%)
Tachycardia
134 (.26%)
Ventricular Septal Defect
134 (.26%)
Intentional Drug Misuse
131 (.25%)
Arthralgia
130 (.25%)
Premature Baby
129 (.25%)
Akathisia
127 (.24%)
Nervousness
126 (.24%)
Medication Error
125 (.24%)
Rhabdomyolysis
125 (.24%)
Lethargy
123 (.24%)
Palpitations
122 (.24%)
Memory Impairment
121 (.23%)
Dyskinesia
120 (.23%)
Pruritus
119 (.23%)
Off Label Use
118 (.23%)
Congenital Anomaly
117 (.23%)
Heart Rate Increased
117 (.23%)
Drug Withdrawal Syndrome Neonatal
114 (.22%)
Hallucination
114 (.22%)
Mania
114 (.22%)
Panic Attack
114 (.22%)
Product Substitution Issue
114 (.22%)
Delirium
113 (.22%)
Disorientation
113 (.22%)
Renal Failure
113 (.22%)
Sleep Disorder
109 (.21%)
Chest Pain
108 (.21%)
Disturbance In Attention
108 (.21%)
Talipes
107 (.21%)
Grand Mal Convulsion
106 (.2%)
Coma
105 (.2%)
Drug Effect Decreased
104 (.2%)
Homicide
103 (.2%)
Paraesthesia
103 (.2%)
Abortion Spontaneous
102 (.2%)
Psychotic Disorder
101 (.19%)
Gait Disturbance
100 (.19%)
Hypokalaemia
100 (.19%)

ExportShare/Embed GraphExport Export Data

This graph shows the top adverse events submitted to the FDA for Fluoxetine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Fluoxetine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Fluoxetine

What are the most common Fluoxetine adverse events reported to the FDA?

Show More Show More

ExportShare/Embed Graph Export Export Data

This graph shows the top categories of adverse events submitted to the FDA for Fluoxetine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Fluoxetine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Fluoxetine According to Those Reporting Adverse Events

Why are people taking Fluoxetine, according to those reporting adverse events to the FDA?

Depression
8442
Product Used For Unknown Indication
1715
Drug Use For Unknown Indication
1664
Anxiety
1064
Obsessive-compulsive Disorder
388
Major Depression
361
Show More Show More
Bipolar Disorder
319
Ill-defined Disorder
114
Antidepressant Therapy
111
Depressed Mood
97
Mental Disorder
84
Premenstrual Syndrome
82
Affective Disorder
77
Panic Attack
74
Panic Disorder
69
Suicide Attempt
65
Post-traumatic Stress Disorder
60
Bipolar I Disorder
59
Schizophrenia
59
Postpartum Depression
59
Stress
56
Drug Exposure During Pregnancy
53
Fibromyalgia
52
Dysthymic Disorder
52
Anxiety Disorder
50
Pain
48
Nervousness
48
Schizoaffective Disorder
39
Insomnia
38
Bulimia Nervosa
34
Generalised Anxiety Disorder
32
Migraine
30
Depressive Symptom
30
Sleep Disorder
27
Psychiatric Symptom
25
Tourettes Disorder
25
Myasthenic Syndrome
24
Prophylaxis
24
Attention Deficit/hyperactivity Dis...
23
Abnormal Behaviour
23
Mood Swings
23
Fatigue
22
Borderline Personality Disorder
21
Psychotic Disorder
19
Eating Disorder
19
Mood Altered
18
Overdose
18
Intentional Overdose
18
Emotional Distress
17
Foetal Exposure During Pregnancy
16
Panic Reaction
15

Drug Labels

LabelLabelerEffective
FluoxetineBryant Ranch Prepack31-JAN-08
FluoxetineBryant Ranch Prepack31-JAN-08
FluoxetineBryant Ranch Prepack08-DEC-08
Fluoxetine HydrochloridePhysicians Total Care, Inc.12-FEB-09
Fluoxetine HydrochloridePar Pharmaceutical, Inc12-FEB-09
FluoxetineMylan Pharmaceuticals Inc.01-JUL-09
ProzacStat Rx USA27-OCT-09
Fluoxetine HydrochloridePhysicians Total Care, Inc.18-JAN-10
FluoxetinePhysicians Total Care, Inc.18-JAN-10
Fluoxetine HydrochlorideMylan Pharmaceuticals Inc.26-MAR-10
Fluoxetine HydrochlorideContract Pharmacy Services-PA05-APR-10
Fluoxetine HydrochlorideKAISER FOUNDATION HOSPITALS30-APR-10
Fluoxetine HydrochlorideState of Florida DOH Central Pharmacy01-JUN-10
Fluoxetine HydrochlorideState of Florida DOH Central Pharmacy01-JUN-10
FluoxetineBlenheim Pharmacal, Inc.30-JUN-10
FluoxetineSTAT RX USA LLC19-JUL-10
Fluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.20-JUL-10
FluoxetineNCS HealthCare of KY, Inc dba Vangard Labs29-JUL-10
FluoxetineContract Pharmacy Services-PA30-JUL-10
FluoxetineLake Erie Medical DBA Quality Care Products LLC19-AUG-10
FluoxetineRebel Distributors Corp27-SEP-10
FluoxetineRebel Distributors Corp28-SEP-10
FluoxetineNCS HealthCare of KY, Inc dba Vangard Labs05-OCT-10
FluoxetineMcKesson Contract Packaging04-NOV-10
FluoxetineUDL Laboratories, Inc.12-NOV-10
FluoxetineMcKesson Packaging Services Business Unit of McKesson Corporation18-NOV-10
Fluoxetine HydrochlorideREMEDYREPACK INC. 21-DEC-10
Fluoxetine HydrochlorideRebel Distributors Corp28-DEC-10
Fluoxetine Preferred Pharmaceuticals, Inc17-JAN-11
Fluoxetine Preferred Pharmaceuticals, Inc17-JAN-11
FluoxetineNorthStar RxLLC13-APR-11
FluoxetineLegacy Pharmaceutical Packaging14-APR-11
FluoxetineLegacy Pharmaceutical Packaging27-APR-11
FluoxetineCardinal Health05-MAY-11
FluoxetineContract Pharmacy Services-PA16-MAY-11
Fluoxetine Lake Erie Medical DBA Quality Care Products LLC24-MAY-11
FluoxetinePD-Rx Pharmaceuticals, Inc.21-JUN-11
Fluoxetine HydrochlorideREMEDYREPACK INC. 21-JUL-11
GaboxetinePhysician Therapeutics LLC01-AUG-11
SentroxatinePhysician Therapeutics LLC01-AUG-11
Sentraflox Am-10Physician Therapeutics LLC17-AUG-11
FluoxetineCardinal Health08-SEP-11
Fluoxetine HydrochlorideREMEDYREPACK INC. 20-SEP-11
Fluoxetine HydrochloridePD-Rx Pharmaceuticals, Inc.13-OCT-11
Fluoxetine HydrochlorideSandoz Inc13-OCT-11
FluoxetineLake Erie Medical & Surgical Supply DBA Quality Care Products LLC09-NOV-11
Fluoxetine HydrochlorideDr.Reddy's Laboratories Limited27-DEC-11
FluoxetineLife Line Home Care Services, Inc.16-JAN-12
FluoxetineDr.Reddy's Laboratories Limited17-FEB-12
Fluoxetine Prodigy Health Supplier01-MAR-12
FluoxetineNCS HealthCare of KY, Inc dba Vangard Labs13-MAR-12
Fluoxetine Unit Dose Services14-MAR-12
FluoxetineAurobindo Pharma Limited14-MAR-12
Fluoxetine HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs19-MAR-12
Fluoxetine Med-Health Pharma, LLC20-MAR-12
FluoxetineMedVantx, Inc.20-MAR-12
FluoxetineSTAT Rx USA LLC09-APR-12
FluoxetineMcKesson Contract Packaging16-APR-12
Fluoxetine HydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLC23-MAY-12
FluoxetineTeva Pharmaceuticals USA Inc07-JUN-12
FluoxetineRebel Distributors Corp13-JUN-12
FluoxetineSTAT Rx USA LLC26-JUN-12
FluoxetineMajor Pharmaceuticals18-JUL-12
FluoxetineTeva Pharmaceuticals USA Inc20-JUL-12
FluoxetineMedsource Pharmaceuticals24-JUL-12
FluoxetineCardinal Health25-JUL-12
FluoxetinePharmaceutical Associates, Inc.31-JUL-12
FluoxetineLake Erie Medical & Surgical Supply DBA Quality Care Products LLC07-AUG-12
FluoxetineLake Erie Medical & Surgical Supply DBA Quality Care Products LLC07-AUG-12
FluoxetineBarr Laboratories Inc.29-AUG-12
Fluoxetine Hydrochloride AvKARE, Inc.30-AUG-12
FluoxetineMorton Grove Pharmaceuticals, Inc.05-SEP-12
FluoxetineHeritage Pharmaceuticals Inc.02-OCT-12
Fluoxetine HydrochlorideAphena Pharma Solutions - Tennessee, Inc.09-NOV-12
Fluoxetine HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs15-NOV-12
FluoxetineTeva Pharmaceuticals USA Inc20-NOV-12
FluoxetineAurobindo Pharma Limited22-NOV-12
Fluoxetine HclEdgemont Pharmaceuticals, LLC04-DEC-12
Fluoxetine Silarx Pharmaceuticals, Inc21-DEC-12
SymbyaxEli Lilly and Company03-JAN-13
Prozac WeeklyEli Lilly and Company03-JAN-13
ProzacDista Products Company03-JAN-13
Olanzapine And FluoxetineSandoz Inc29-JAN-13
Fluoxetine HydrochlorideSandoz Inc31-JAN-13
FluoxetineRanbaxy Pharmaceuticals Inc.06-FEB-13
FluoxetineAmerican Health Packaging06-FEB-13
FluoxetineAurobindo Pharma Limited07-FEB-13
FluoxetineREMEDYREPACK INC. 25-FEB-13
FluoxetineREMEDYREPACK INC. 26-FEB-13
FluoxetinePar Pharmaceutical Companies, Inc.26-FEB-13
Olanzapine And FluoxetinePar Pharmaceutical, Inc27-FEB-13
Fluoxetine HydrochlorideBarr Laboratories Inc.05-MAR-13
FluoxetineMedVantx, Inc.08-MAR-13
FluoxetineTeva Pharmaceuticals USA Inc08-MAR-13
FluoxetinePliva Inc.08-MAR-13
FluoxetineTeva Pharmaceuticals USA Inc08-MAR-13
FluoxetineREMEDYREPACK INC. 18-MAR-13
FluoxetineNCS HealthCare of KY, Inc dba Vangard Labs27-MAR-13
Olanzapine And FluoxetineTeva Pharmaceuticals USA Inc08-APR-13
Fluoxetine HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs09-APR-13
FluoxetineCardinal Health10-APR-13

Fluoxetine Case Reports

What Fluoxetine safety concerns are being reported by doctors and researchers in the medical literature?

Powered by Google

About Results

This report contains aggregated drug side effects and adverse events for Fluoxetine. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

Comments

Share your experience with Fluoxetine.