FDA Adverse Events Reports (FAERS) Summary for MUCINEX

These tables and charts are based on 32,676 total reports for MUCINEX (GUAIFENESIN) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 31,348 pharmaceutical company-submitted and non-U.S. FAERS reports and 1,328 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 1,328 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch MUCINEX summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with MUCINEX (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	3265
2	DIZZINESS	2171
3	SHORTNESS OF BREATH	2159
4	DIARRHEA	2055
5	NAUSEA	2000
6	FATIGUE	1822
7	HEADACHE	1652
8	COUGH	1562
9	PNEUMONIA	1373
10	INSOMNIA	1122
11	PAIN	1061
12	VOMITING	1055
13	PRODUCT USE IN UNAPPROVED INDICATION	1044
14	ACCIDENTAL OVERDOSE	1017
15	FEELING ABNORMAL	928
16	LACK OF STRENGTH AND ENERGY (ASTHENIA)	915
17	SINUSITIS	884
18	MALAISE	847
19	FALL	815
20	ANXIETY	793
21	DROWSINESS	783
22	OFF LABEL USE	778
23	OVERDOSE	767
24	NO ADVERSE EVENT	752
25	RASH	751
26	COVID-19	739
27	DEATH	737
28	COMMON COLD	732
29	INCORRECT DRUG ADMINISTRATION DURATION	701
30	BRONCHITIS	691
31	ITCHING	685
32	BLOOD PRESSURE INCREASED	670
33	JOINT PAIN	661
34	ABDOMINAL PAIN UPPER	649
35	CONDITION AGGRAVATED	648
36	WEIGHT DECREASED	642
37	FEVER	606
38	CONSTIPATION	589
39	PRODUCT USE ISSUE	570
40	PAIN IN EXTREMITY	558
41	BACK PAIN	552
42	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	550
43	URINARY TRACT INFECTION	549
44	HIGH BLOOD PRESSURE	536
45	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	530
46	CHEST PAIN	525
47	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	510
48	INCORRECT PRODUCT ADMINISTRATION DURATION	510
49	PRODUCT DOSE OMISSION ISSUE	510
50	PRODUCTIVE COUGH	486
51	ASTHMA	477
52	DECREASED APPETITE	472
53	ABDOMINAL DISCOMFORT	463
54	HYPERSENSITIVITY	454
55	TREMOR	451
56	PALPITATIONS	446
57	NOSEBLEED	442
58	HEART RATE INCREASED	434
59	DRUG EFFECTIVE FOR UNAPPROVED INDICATION	417
60	MUSCLE SPASMS	407
61	LOWER LIMBS SWELLING	402
62	THROAT PAIN	399
63	CHEST DISCOMFORT	397
64	DEPRESSION	395
65	NASAL CONGESTION	384
66	EXPIRED PRODUCT ADMINISTERED	382
67	LOW BLOOD PRESSURE	377
68	CONFUSIONAL STATE	374
69	PRODUCT QUALITY ISSUE	372
70	UPPER RESPIRATORY TRACT INFECTION	371
71	DEHYDRATION	366
72	HIVES	364
73	CHRONIC KIDNEY DISEASE	355
74	GAIT DISTURBANCE	351
75	INFLUENZA	335
76	WEIGHT INCREASED	329
77	KIDNEY FAILURE	325
78	SKIN REDNESS	323
79	NUMBNESS	322
80	ABDOMINAL PAIN	321
81	DRY MOUTH	321
82	RUNNY NOSE	320
83	EXCESS SWEATING	319
84	PINS AND NEEDLES	315
85	ILLNESS	306
86	ANEMIA	305
87	VISION BLURRED	304
88	SWELLING OF LIMBS	303
89	GASTROOESOPHAGEAL REFLUX DISEASE	301
90	WHEEZING	300
91	DRUG HYPERSENSITIVITY	297
92	INFECTION	294
93	LOSS OF CONSCIOUSNESS	294
94	CHILLS	290
95	HALLUCINATION	287
96	DIFFICULTY SWALLOWING	284
97	MUSCLE PAIN	282
98	HOARSE VOICE	275
99	CONGESTIVE HEART FAILURE	272
100	ACUTE KIDNEY INJURY	269

Latest Known Outcomes for Reactions Reported for MUCINEX

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	16810
2	Patient has not recovered/symtoms have not resolved	9655
3	Patient recovered	7548
4	Patient is recovering/symptoms resolving	2596
5	Patient died	1062
6	Patient has recovered but has consequent health issues	109

Search all MedWatch and FAERS by keyword:

MUCINEX Total Reports

Male	Female	Unknown	Total
10575	20106	1995	32,676

Top Countries Reporting

	Country	Number of Reports
1	United States	29374
2	Canada	58
3	New Zealand	15
4	Puerto Rico	10
5	United Kingdom	5
6	Spain	4
7	China	3
8	Australia	2
9	Germany	2
10	Malaysia	2

Outcomes for Reports

Serious: 13072
Not Serious: 19584
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Respiratory tract congestion
Product used for unknown indication
Cough
Productive cough
Hypersensitivity

Top Companies Reporting

TAKEDA
RECKITT BENCKISER
RECKITT BENCKISER

Safety-Related FDA Updates

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 the cases for MUCINEX reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. 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. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "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."

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 or comments about this report.