Pepcid Complete: adverse event reports filed with FDA

1,219

reports as suspect product

0% of all reports · about 55 a year

80

reports, 12 months to June 2026

67 in the 12 months before

8.1%

marked serious by the reporter

96.3% across the class

0%

record death among outcomes, as reported

0 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Pepcid Complete reports recording the termmedian drug in histamine-2 receptor antagonist

1. Drug ineffectivethe medicine did not work as expected16.2%197
2. Product use in unapproved indicationused for a purpose not on the label7.2%88
3. Therapeutic response unexpected7.1%86
4. Wrong technique in product usage processthe product was used in the wrong way6.6%80
5. Incorrect dose administeredthe wrong dose was given6.2%76
6. Product physical issuea physical defect in the product6.2%75
7. Off label useused for a purpose or in a way not on the label4.8%59
8. Dysgeusiaaltered taste4.8%58
9. Product use issuea problem in how the product was used4.4%54
10. Exposure during pregnancythe medicine was taken during pregnancy4.3%53
11. Overdosea dose above the recommended amount4.3%52
12. Accidental overdosean accidental overdose3.2%39
13. Accidental exposure to product2.8%34
14. Diarrhoealoose or frequent stools2.7%33
15. Accidental drug intake by child2.6%32
16. Dyspepsiaindigestion2.6%32
17. Accidental exposure to product by child2.5%30
18. Nauseafeeling sick2.3%28
19. Abdominal discomfortstomach discomfort2.1%26
20. Drug effect incomplete2.1%25
21. Abdominal pain upperupper stomach pain2%24
22. Product taste abnormalthe product tasted odd1.6%20
23. Headachehead pain1.6%19
24. Therapeutic product effect incomplete1.6%19
25. Incorrect drug administration duration1.5%18
26. Poor quality product administered1.4%17
27. Expired product administeredthe product was used past its expiry date1.3%16
28. Product packaging issuea problem with the packaging1.3%16
29. Dizzinesslight-headedness or unsteadiness1.2%15
30. Adverse eventan unwanted medical event, type not specified1.1%13

Top 30 of 126 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 8 drugs in the histamine-2 receptor antagonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 270,928 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.4% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 1,219 reports.

Drugs most often listed in the same reports

Other products listed in reports where Pepcid Complete is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the histamine-2 receptor antagonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Pepcid Complete as a suspect or interacting product; reports listing it only as a concomitant medication (1,116) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.