Prozac (fluoxetine hydrochloride) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Prozac
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Fluoxetine hydrochloride
Class: Serotonin reuptake inhibitor
Also reported as: Prozac /00724401/

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 11,547 adverse event reports that name Prozac. In these reports the drug is a suspect or interacting product.

In the same period, 38,593 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 276 reports in the 12 months to June 2026 and 274 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 276 (under 0.1%) name Prozac. Reports for male patients were 24.1% of the reports that name Prozac and 34.6% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Prozac is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 86 reports that name Prozac.
In January to March 2026, FDA received 61.
In April to June 2025, FDA received 81.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 955 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 11,545 of the 11,547 reports (99.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 955 terms.

Reaction terms in the reports that name Prozac, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 11,547 reports
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	1,390	12%
Drug ineffectivethe medicine did not work as expected	1,301	11.3%
Depressionlow mood	844	7.3%
Insomniadifficulty sleeping	709	6.1%
Anxiety	707	6.1%
Suicidal ideationthoughts of suicide	637	5.5%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	630	5.5%
Fatiguetiredness	584	5.1%
Feeling abnormalfeeling odd or not right	557	4.8%
Weight increasedweight gain	546	4.7%
Drug interactionan interaction between medicines	530	4.6%
Nauseafeeling sick	501	4.3%
Painpain, site not specified	474	4.1%
Off label useused for a purpose or in a way not on the label	428	3.7%
Headachehead pain	423	3.7%
Suicide attempta suicide attempt	398	3.4%
Somnolencedrowsiness	390	3.4%
Dizzinesslight-headedness or unsteadiness	388	3.4%
Tremorshaking	343	3%
Gait disturbancedifficulty walking	318	2.8%
Agitationrestlessness	309	2.7%
Vomitingbeing sick	309	2.7%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	300	2.6%
Falla fall	298	2.6%
Dyspnoeashortness of breath	296	2.6%
Malaisegeneral feeling of being unwell	296	2.6%
Astheniaweakness or lack of energy	286	2.5%
Irritability	281	2.4%
Weight decreasedweight loss	279	2.4%
Aggressionaggressive behaviour	260	2.3%
Confusional stateconfusion	259	2.2%
Exposure during pregnancythe medicine was taken during pregnancy	258	2.2%
Diarrhoealoose or frequent stools	252	2.2%
Atrial septal defect	241	2.1%
Premature babya baby born early	239	2.1%
Musculoskeletal stiffnessstiffness in muscles or joints	238	2.1%
Drug withdrawal syndromesymptoms on stopping a medicine	237	2.1%
Drug exposure during pregnancythe medicine was taken during pregnancy	226	2%
Completed suicidedeath by suicide	225	1.9%
Overdosea dose above the recommended amount	222	1.9%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	221	1.9%
Decreased appetitereduced appetite	211	1.8%
Abnormal behaviourunusual behaviour	209	1.8%
Hyperhidrosisexcessive sweating	207	1.8%
White blood cell count abnormal	205	1.8%
Memory impairmentmemory problems	199	1.7%
Talipes	196	1.7%
Hypertensionhigh blood pressure	195	1.7%
Arthralgiajoint pain	183	1.6%
Condition aggravatedthe condition being treated got worse	179	1.6%

Download all 955 terms of Prozac (CSV)

The counts add to more than 11,547 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Fluoxetine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Fluoxetine	Generic name	28,319
Fluoxetine hydrochloride	Generic name	6,209
Prozac (this page)	Brand name	11,547

Sum of the separately reported names: 46,075. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Prozac, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	560	413	81	46	195	24	15	190	147
2005	483	376	51	42	165	26	8	206	107
2006	457	373	55	15	178	17	11	189	84
2007	318	279	39	16	121	14	8	146	39
2008	344	303	37	21	138	7	23	163	41
2009	317	272	54	24	98	12	11	164	45
2010	296	272	40	14	105	20	23	162	24
2011	411	347	28	27	110	14	73	204	64
2012	719	651	56	44	111	15	326	452	68
2013	463	363	40	29	140	23	70	256	100
2014	554	403	22	25	119	28	121	249	151
2015	2,552	1,389	68	165	429	37	699	1,018	1,163
2016	571	327	16	39	137	13	64	229	244
2017	423	256	14	16	93	19	21	201	167
2018	405	286	25	23	139	16	7	182	119
2019	539	326	22	26	129	10	5	231	213
2020	488	370	20	27	126	6	5	285	118
2021	369	262	14	10	78	9	2	202	107
2022	310	224	19	6	73	11	7	169	86
2023	254	138	11	10	57	8	0	94	116
2024	259	136	14	11	35	10	0	108	123
2025	285	160	14	21	50	47	0	105	125
2026	170	104	20	6	32	10	0	86	66

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Prozac, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Prozac, by the year in which FDA received them
Year	Reports
2004	486
2005	509
2006	457
2007	330
2008	300
2009	371
2010	343
2011	461
2012	1,018
2013	600
2014	687
2015	2,075
2016	530
2017	428
2018	409
2019	529
2020	484
2021	332
2022	297
2023	238
2024	242
2025	274
2026	147

Reports that name Prozac, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Prozac
Age	Reports	Share
Under 2	330	2.9%
2 to 11	136	1.2%
12 to 17	502	4.3%
18 to 44	2,054	17.8%
45 to 64	2,012	17.4%
65 to 74	601	5.2%
75 and over	402	3.5%
Age not given	5,510	47.7%

Sex of the patient in the reports that name Prozac
Sex	Reports	Share
Female	6,883	59.6%
Male	2,786	24.1%
Unknown or not given	1,878	16.3%

Type of reporter in the reports that name Prozac
Reporter	Reports	Share
Physician	2,529	21.9%
Pharmacist	255	2.2%
Other health professional	1,234	10.7%
Lawyer	658	5.7%
Consumer or non-health professional	6,079	52.6%
Not given	792	6.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 70.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Prozac record
Indication as recorded (MedDRA)	Reports	Share
Depression	2,968	25.7%
Anxiety	404	3.5%
Major depression	222	1.9%
Bipolar disorder	136	1.2%
Obsessive-compulsive disorder	126	1.1%
Antidepressant therapy	34	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 11,547 reports.

Drugs in the same reports

Other drugs that the reports of Prozac name, in any role, in order of name
Drug	Reports that name the two
Abilify	643
Bupropion hydrochloride	722
Cymbalta	922
Lexapro	252
Paxil	343
Seroquel	258
Venlafaxine hydrochloride	292
Xanax	601
Zoloft	499
Zyprexa	322

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Fluoxetine same ingredient
Fluoxetine hydrochloride same ingredient
Paxil same class
Sertraline same class
Paroxetine hydrochloride same class
Sertraline hcl same class
Paroxetine same class
Sertraline hydrochloride same class
Provigil next in the A to Z list
Prucalopride next in the A to Z list
Provera next in the A to Z list
Pseudoephedrine next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for ProzacThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

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Reported Reactions. Prozac: adverse event reports that FDA received. https://reportedreactions.com/drug/prozac/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Prozac as a suspect or interacting product. The 38,593 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Prozac was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Prozac?

No. It is a count of what people reported to FDA: 11,547 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (52.6%), physician (21.9%) and other health professional (10.7%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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