Pepcid Ac Maximum Strength: adverse event reports filed with FDA

643

reports as suspect product

0% of all reports · about 58 a year

28

reports, 12 months to June 2026

28 in the 12 months before

3.6%

marked serious by the reporter

96.3% across the class

0.6%

record death among outcomes, as reported

4 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 Ac Maximum Strength reports recording the termmedian drug in histamine-2 receptor antagonist

1. Drug ineffectivethe medicine did not work as expected19.8%127
2. Product use in unapproved indicationused for a purpose not on the label12.9%83
3. Off label useused for a purpose or in a way not on the label11.8%76
4. Therapeutic response unexpected9.5%61
5. Incorrect dose administeredthe wrong dose was given5.6%36
6. Product use issuea problem in how the product was used5.3%34
7. Diarrhoealoose or frequent stools4.5%29
8. Dizzinesslight-headedness or unsteadiness3.7%24
9. Abdominal pain upperupper stomach pain3.3%21
10. Wrong technique in product usage processthe product was used in the wrong way3.3%21
11. Exposure during pregnancythe medicine was taken during pregnancy3.1%20
12. Incorrect drug administration duration2.6%17
13. Dyspepsiaindigestion2.3%15
14. Therapeutic product effect incomplete2.2%14
15. Drug effect incomplete2%13
16. Abdominal discomfortstomach discomfort1.9%12
17. Nauseafeeling sick1.7%11
18. Overdosea dose above the recommended amount1.7%11
19. Headachehead pain1.6%10
20. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times1.6%10
21. Product label issuea problem with the label1.6%10
22. Drug ineffective for unapproved indication1.4%9
23. Rashskin rash1.4%9
24. Fatiguetiredness1.2%8
25. Intentional product use issuedeliberate use not as intended1.2%8
26. Product packaging issuea problem with the packaging1.1%7
27. Anxietyanxiety0.9%6
28. Contraindicated product administered0.9%6
29. Faeces discoloured0.9%6
30. Insomniadifficulty sleeping0.9%6

Top 30 of 108 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 643 reports.

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 Ac Maximum Strength as a suspect or interacting product; reports listing it only as a concomitant medication (29) 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.