Pepcid (famotidine) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Famotidine
Class: Histamine-2 receptor antagonist
Also reported as: Pepcid /00706001/, Pepcid Injection, Pepcid /00305201/

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 2,589 adverse event reports that name Pepcid. In these reports the drug is a suspect or interacting product.

In the same period, 30,135 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 122 reports in the 12 months to June 2026 and 138 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, 122 (under 0.1%) name Pepcid. Reports from consumers or other non-health professionals were 57.7% of the reports that name Pepcid and 45.8% 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 Pepcid 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 40 reports that name Pepcid.
In January to March 2026, FDA received 28.
In April to June 2025, FDA received 20.

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 218 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 2,566 of the 2,589 reports (99.1%).

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 218 terms.

Reaction terms in the reports that name Pepcid, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,589 reports
Drug ineffectivethe medicine did not work as expected	369	14.3%
Product use in unapproved indicationused for a purpose not on the label	260	10%
Off label useused for a purpose or in a way not on the label	195	7.5%
Exposure during pregnancythe medicine was taken during pregnancy	189	7.3%
Therapeutic response unexpected	161	6.2%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	86	3.3%
Diarrhoealoose or frequent stools	83	3.2%
Nauseafeeling sick	73	2.8%
Dyspepsiaindigestion	68	2.6%
Headachehead pain	63	2.4%
Vomitingbeing sick	63	2.4%
Dyspnoeashortness of breath	56	2.2%
Fatiguetiredness	54	2.1%
Gastrooesophageal reflux diseaseacid reflux	53	2%
Rhabdomyolysismuscle breakdown	51	2%
Product use issuea problem in how the product was used	50	1.9%
Liver disorder	48	1.9%
Abdominal pain upperupper stomach pain	46	1.8%
Dizzinesslight-headedness or unsteadiness	44	1.7%
Malaisegeneral feeling of being unwell	42	1.6%
Rashskin rash	41	1.6%
Drug interactionan interaction between medicines	36	1.4%
Chronic kidney diseaselong-term kidney disease	35	1.4%
Therapeutic product effect incomplete	35	1.4%
Abdominal discomfortstomach discomfort	33	1.3%
Feeling abnormalfeeling odd or not right	33	1.3%
Urticariahives	33	1.3%
Anxiety	32	1.2%
Painpain, site not specified	32	1.2%
Astheniaweakness or lack of energy	31	1.2%
Hypotensionlow blood pressure	31	1.2%
Insomniadifficulty sleeping	31	1.2%
Renal failurekidney failure	31	1.2%
Pruritusitching	30	1.2%
Pyrexiafever	29	1.1%
Decreased appetitereduced appetite	28	1.1%
Overdosea dose above the recommended amount	28	1.1%
Pneumonialung infection	28	1.1%
Abdominal painstomach or belly pain	27	1%
Condition aggravatedthe condition being treated got worse	27	1%
Pain in extremitypain in an arm or leg	27	1%
Adverse eventan unwanted medical event, type not specified	26	1%
Platelet count decreasedlow platelet count	26	1%
Constipation	25	1%
Blood creatine phosphokinase increased	23	0.9%
Cough	23	0.9%
Hepatic function abnormal	22	0.8%
Anaemialow red blood cells	21	0.8%
Chest discomfort	21	0.8%
Somnolencedrowsiness	21	0.8%

Download all 218 terms of Pepcid (CSV)

The counts add to more than 2,589 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 Famotidine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Famotidine	Generic name	6,009
Pepcid (this page)	Brand name	2,589
Pepcid AC	Brand name	1,096
Pepcid Ac Maximum Strength	Brand name	643

Sum of the separately reported names: 10,337. 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 Pepcid, 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	126	122	16	16	58	8	1	72	4
2005	118	110	15	11	57	8	1	49	8
2006	74	72	9	7	35	5	0	32	2
2007	65	64	13	8	30	2	0	24	1
2008	65	62	12	5	22	1	0	34	3
2009	101	93	16	8	38	4	1	55	8
2010	88	82	9	3	28	3	0	51	6
2011	87	77	3	5	29	5	0	54	10
2012	53	50	3	1	15	3	1	38	3
2013	55	30	2	1	13	1	1	23	25
2014	32	18	0	3	9	0	0	12	14
2015	134	28	3	1	11	3	0	21	106
2016	126	19	1	1	7	1	0	13	107
2017	115	20	0	0	7	0	0	16	95
2018	93	22	2	2	6	1	1	14	71
2019	114	38	2	3	10	5	2	29	76
2020	332	47	1	1	17	5	0	39	285
2021	223	39	3	2	14	4	0	28	184
2022	140	37	0	1	14	3	1	29	103
2023	121	21	2	3	9	1	0	19	100
2024	144	29	5	1	10	0	0	20	115
2025	111	11	0	0	4	1	0	7	100
2026	72	15	0	0	3	1	0	12	57

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 Pepcid, 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 Pepcid, by the year in which FDA received them
Year	Reports
2004	111
2005	116
2006	86
2007	62
2008	71
2009	95
2010	84
2011	92
2012	83
2013	38
2014	35
2015	137
2016	130
2017	116
2018	96
2019	114
2020	331
2021	219
2022	143
2023	113
2024	139
2025	110
2026	68

Reports that name Pepcid, 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 Pepcid
Age	Reports	Share
Under 2	20	0.8%
2 to 11	36	1.4%
12 to 17	22	0.8%
18 to 44	233	9%
45 to 64	389	15%
65 to 74	268	10.4%
75 and over	243	9.4%
Age not given	1,378	53.2%

Sex of the patient in the reports that name Pepcid
Sex	Reports	Share
Female	1,398	54%
Male	630	24.3%
Unknown or not given	561	21.7%

Type of reporter in the reports that name Pepcid
Reporter	Reports	Share
Physician	508	19.6%
Pharmacist	182	7%
Other health professional	305	11.8%
Lawyer	17	0.7%
Consumer or non-health professional	1,494	57.7%
Not given	83	3.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 75.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Pepcid record
Indication as recorded (MedDRA)	Reports	Share
Gastrooesophageal reflux disease	170	6.6%
Dyspepsia	147	5.7%
Gastritis	50	1.9%
Gastric ulcer	38	1.5%
Urticaria	32	1.2%
Prophylaxis	23	0.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,589 reports.

Drugs in the same reports

Other drugs that the reports of Pepcid name, in any role, in order of name
Drug	Reports that name the two
Aspirin	120
Benadryl	192
Lasix	66
Nexium	88
Pantoprazole sodium	68
Prednisone	69
Prilosec	87
Tylenol	72
Zantac	73
Zyrtec	107

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

Famotidine same ingredient
Pepcid AC same ingredient
Pepcid Ac Maximum Strength same ingredient
Famotidine, calcium carbonate and magnesium hydroxide same class
Cimetidine same class
Pepcid Complete same class
Pentoxifylline next in the A to Z list
Pentostatin next in the A to Z list
Pentobarbital next in the A to Z list
Pentazocine Lactate next in the A to Z list
Pepcid Rpd next in the A to Z list
Pentazocine 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 PepcidThe 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.

Cite this page

Reported Reactions. Pepcid: adverse event reports that FDA received. https://reportedreactions.com/drug/pepcid/ 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 Pepcid as a suspect or interacting product. The 30,135 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 Pepcid 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 Pepcid?

No. It is a count of what people reported to FDA: 2,589 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 (57.7%), physician (19.6%) and other health professional (11.8%). 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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