Mucinex: adverse event reports filed with FDA

5,107

reports as suspect product

0% of all reports · about 227 a year

351

reports, 12 months to June 2026

462 in the 12 months before

19.8%

marked serious by the reporter

33.2% across the class

0.6%

record death among outcomes, as reported

29 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 Mucinex reports recording the termmedian drug in expectorant

1. Drug ineffectivethe medicine did not work as expected20.8%1,064
2. Dizzinesslight-headedness or unsteadiness6%308
3. Incorrect drug administration duration6%307
4. Product use in unapproved indicationused for a purpose not on the label5.2%265
5. No adverse eventno adverse event was reported5.1%262
6. Diarrhoealoose or frequent stools4.9%252
7. Product use issuea problem in how the product was used4.2%216
8. Nauseafeeling sick4.2%212
9. Insomniadifficulty sleeping3.7%190
10. Headachehead pain3.6%183
11. Drug effective for unapproved indication3.2%162
12. Dyspnoeashortness of breath3.2%161
13. Feeling abnormalfeeling odd or not right3.1%156
14. Incorrect product administration duration3%153
15. Coughcough2.8%142
16. Blood pressure increaseda raised blood pressure reading2.7%137
17. Somnolencedrowsiness2.6%135
18. Abdominal pain upperupper stomach pain2.2%114
19. Vomitingbeing sick2.2%112
20. Condition aggravatedthe condition being treated got worse2.1%107
21. Expired product administeredthe product was used past its expiry date2%104
22. Wrong technique in product usage processthe product was used in the wrong way1.9%98
23. Accidental overdosean accidental overdose1.9%97
24. Overdosea dose above the recommended amount1.9%95
25. Rashskin rash1.8%94
26. Fatiguetiredness1.8%91
27. Malaisegeneral feeling of being unwell1.8%91
28. Heart rate increaseda fast heart rate reading1.7%85
29. Epistaxisnosebleed1.6%80
30. Anxietyanxiety1.4%72

Top 30 of 394 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 10 drugs in the expectorant 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 51,345 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. 98.5% 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 5,107 reports.

Drugs most often listed in the same reports

Other products listed in reports where Mucinex 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 expectorant 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 Mucinex as a suspect or interacting product; reports listing it only as a concomitant medication (15,695) 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.