Pharmacologic class (EPC) · 10 drug pages

Expectorant: adverse event reports filed with FDA

51,345 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

51,345
reports across the class: 0.3% of all reports; 6,901
reports, 12 months to June 2026: 3,683 in the 12 months before; 33.2%
marked serious by the reporter: 57.4% across all reports; 10
drugs with a page: brand and generic names counted separately

Expectorant is a pharmacologic class (an FDA Established Pharmacologic Class) with 10 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 51,345 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

6,901 reports arrived in the 12 months to June 2026, up 87% from 3,683 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 33.2% of the class's reports are marked serious, 5% record death among the outcomes and 9.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (21.5%), exposure during pregnancy (7%) and product use in unapproved indication (5.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
TylenolAcetaminophen	brand	30,726	5,536	39.8%	Drug ineffective
MucinexGuaifenesin	brand	5,107	351	19.8%	Drug ineffective
DelsymDextromethorphan	brand	3,579	144	15%	Drug ineffective
Mucinex Dm Maximum StrengthGuaifenesin and dextromethorphan hydrobromide	brand	3,328	177	11.5%	Dizziness
Mucinex DMGuaifenesin and dextromethorphan hydrobromide	brand	2,422	119	28%	Drug ineffective
Mucinex Maximum StrengthGuaifenesin	brand	2,227	187	7.1%	Drug ineffective
Dextromethorphan hydrobromide	generic	1,670	116	75.5%	Drug abuse
Guaifenesin	generic	1,208	108	45.6%	Drug ineffective
Dextromethorphan hydrobromide,guaifenesin	generic	576	139	12.7%	Drug ineffective
Mucinex DGuaifenesin and pseudoephedrine hydrochloride	brand	502	24	34.1%	Insomnia

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected21.5%11,026
Exposure during pregnancythe medicine was taken during pregnancy7%3,606
Product use in unapproved indicationused for a purpose not on the label5.5%2,841
Overdosea dose above the recommended amount4.8%2,452
Dizzinesslight-headedness or unsteadiness4.7%2,421
Nauseafeeling sick4.6%2,346
Headachehead pain4.5%2,321
Off label useused for a purpose or in a way not on the label4.4%2,280
Diarrhoealoose or frequent stools4%2,071
Drug hypersensitivityan allergic-type reaction to a medicine3.7%1,875
Painpain, site not specified3.6%1,863
Vomitingbeing sick3.3%1,685
Fatiguetiredness3.2%1,652
Product use issuea problem in how the product was used3%1,527
Accidental overdosean accidental overdose2.9%1,497
Dyspnoeashortness of breath2.8%1,448
Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.5%1,295
Somnolencedrowsiness2.5%1,290
Insomniadifficulty sleeping2.4%1,230
Therapeutic product effect incomplete2.3%1,158
Pyrexiafever2.2%1,155
Hyperhidrosisexcessive sweating2.2%1,149
Autism spectrum disorder2.1%1,099
Rashskin rash2.1%1,089
Incorrect dose administeredthe wrong dose was given2.1%1,061

Solid bar: share of all class reports. Hollow bar: the median share across the 10 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death5%2,548

Life-threatening1.6%810

Hospitalisation (initial or prolonged)9.6%4,929

Disability1%491

Congenital anomaly0.2%107

Other serious24.8%12,727

Not serious66.8%34,301

Patient age

Under 21.2%627

2 to 112.7%1,370

12 to 171.5%765

18 to 449.3%4,755

45 to 6411.6%5,969

65 to 747.2%3,682

75 and over9.9%5,059

Age not given56.7%29,118

Who reported

Physician5.7%2,931

Pharmacist1.2%602

Other health professional10.4%5,333

Lawyer0.6%306

Consumer or non-health professional80.8%41,478

Not given1.4%695

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Expectorant reports

Which drugs are in the Expectorant class on this site?

Tylenol, Mucinex, Delsym, Mucinex Dm Maximum Strength, Mucinex DM and Mucinex Maximum Strength and 4 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

51,345 reports through June 2026, 6,901 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (21.5%), exposure during pregnancy (7%), product use in unapproved indication (5.5%), overdose (4.8%) and dizziness (4.7%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.