MUCINEX FDA MedWatch Direct Reports Summary
These tables and charts are created from 1,328 voluntary U.S. reports for MUCINEX (GUAIFENESIN) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.
For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS MUCINEX Report.
Top Adverse Effects Associated with MUCINEX (from U.S. FDA Medwatch Reports)
Side Effect # of FDA Reports 1 DIZZINESS 109 2 SHORTNESS OF BREATH 100 3 NAUSEA 87 4 HEADACHE 82 5 FATIGUE 80 6 DEATH 73 7 PNEUMONIA 61 8 DIARRHEA 59 9 INSOMNIA 57 10 PAIN 53 11 LACK OF STRENGTH AND ENERGY (ASTHENIA) 47 12 VOMITING 47 13 ITCHING 46 14 FEELING ABNORMAL 44 15 DRUG INEFFECTIVE 43 16 ANXIETY 41 17 THERAPY INTERRUPTED 41 18 JOINT PAIN 38 19 BLOOD PRESSURE INCREASED 37 20 HEART RATE INCREASED 37 21 THERAPY CESSATION 37 22 TREMOR 37 23 ABDOMINAL PAIN UPPER 36 24 RASH 35 25 CONFUSIONAL STATE 34
MUCINEX Total Medwatch Safety Reports by Patient Sex
| Male | Female | Unknown | Total |
|---|---|---|---|
| 414 | 889 | 25 | 1,328 |
| Medwatch Reporter Type | Count |
| Consumer | 597 |
| Physician | 19 |
| Pharmacist | 220 |
| Other Health Professional | 205 |
| Top Indications | |
| Respiratory tract congestion | |
| Product used for unknown indication | |
| Cough | |
| Productive cough | |
| Hypersensitivity | |
Type of Outcome Reported
Serious: 938
Not Serious: 390
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.
Suspected Role
Primary Suspect: 1327
Concomitant Drugs: 1214
Note: A single MedWatch report can list more than one drug. This summary includes MUCINEX identified as the suspect drug or as a concomitantly taken drug.
For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.
NOTES
This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.
After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"
The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.
Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."
FDA uses the "MedDRA" classification system to describe reported adverse
reactions. MedDRA is a standardized medical terminology that facilitates
sharing of regulatory information internationally. In some cases, "patient
friendly" terms for the layman designated by MedDRA have been substituted
for medical jargon. Please
contact us
with questions about this report.