FDA Adverse Events Reports (FAERS) Summary for ADVIL LIQUI-GELS

These tables and charts are based on 4,221 total reports for ADVIL LIQUI-GELS (IBUPROFEN) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 4,212 pharmaceutical company-submitted and non-U.S. FAERS reports and 9 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 9 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch ADVIL LIQUI-GELS summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with ADVIL LIQUI-GELS (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	477
2	PRODUCT USE IN UNAPPROVED INDICATION	336
3	DRUG EFFECTIVE FOR UNAPPROVED INDICATION	263
4	NAUSEA	231
5	PAIN	204
6	ABDOMINAL PAIN UPPER	158
7	HEADACHE	157
8	DIZZINESS	150
9	FATIGUE	133
10	VOMITING	128
11	SHORTNESS OF BREATH	115
12	DIARRHEA	110
13	INCORRECT DOSE ADMINISTERED	106
14	PRODUCT COMPLAINT	104
15	ABDOMINAL DISCOMFORT	101
16	MALAISE	99
17	ITCHING	99
18	INSOMNIA	94
19	CONDITION AGGRAVATED	91
20	OVERDOSE	87
21	ANXIETY	84
22	DROWSINESS	83
23	GALLSTONES	79
24	ORAL DISCOMFORT	79
25	POOR QUALITY PRODUCT ADMINISTERED	79
26	CHEST PAIN	78
27	LACK OF STRENGTH AND ENERGY (ASTHENIA)	77
28	FEELING ABNORMAL	77
29	RASH	74
30	HIVES	74
31	JOINT PAIN	71
32	PULMONARY EMBOLISM	71
33	CHOLECYSTITIS CHRONIC	70
34	HYPERSENSITIVITY	70
35	PAIN IN EXTREMITY	70
36	PINS AND NEEDLES	68
37	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	68
38	INDIGESTION	66
39	BACK PAIN	65
40	ABDOMINAL PAIN	64
41	DEEP VEIN THROMBOSIS	64
42	PRODUCT PHYSICAL ISSUE	64
43	DEPRESSION	62
44	SWELLING OF LIMBS	61
45	FEVER	60
46	NUMBNESS	58
47	INTENTIONAL PRODUCT MISUSE	57
48	FLUSHING	56
49	SKIN REDNESS	55
50	PRODUCT QUALITY ISSUE	53
51	CONSTIPATION	52
52	INJURY	52
53	KIDNEY FAILURE	50
54	THROAT IRRITATION	50
55	FALL	49
56	FACIAL SWELLING	49
57	COELIAC DISEASE	47
58	WEIGHT DECREASED	47
59	METALLIC OR ALTERED TASTE	45
60	HIGH BLOOD PRESSURE	45
61	DRUG HYPERSENSITIVITY	44
62	GALLBLADDER DISORDER	44
63	WEIGHT INCREASED	44
64	GAIT DISTURBANCE	43
65	PRODUCT USE ISSUE	43
66	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	42
67	BURNING SENSATION	41
68	COUGH	41
69	STROKE	40
70	CHILLS	40
71	DRUG EFFECT INCOMPLETE	40
72	DRUG EFFECT DECREASED	39
73	DRUG EFFECT DECREASED	39
74	DIFFICULTY SWALLOWING	39
75	MUSCLE PAIN	38
76	BLOOD PRESSURE INCREASED	37
77	EMOTIONAL DISTRESS	37
78	EXPIRED PRODUCT ADMINISTERED	37
79	FEELING HOT	37
80	NUMBNESS IN THE MOUTH	37
81	LIP SWELLING	37
82	STRESS	37
83	DRUG EFFECT INCREASED	37
84	ABDOMINAL DISTENSION	36
85	EYE SWELLING	36
86	RENAL FAILURE ACUTE	36
87	EXCESS SWEATING	35
88	PALPITATIONS	35
89	UNEVALUABLE EVENT	35
90	INFLUENZA LIKE ILLNESS	32
91	MUSCLE SPASMS	32
92	DECREASED APPETITE	31
93	BLOOD GLUCOSE INCREASED	30
94	CHEST DISCOMFORT	30
95	INJECTION SITE PAIN	30
96	OFF LABEL USE	30
97	PRODUCT USE COMPLAINT	30
98	CHOLECYSTITIS	29
99	INJECTION SITE REDNESS	29
100	MIGRAINE	29

Latest Known Outcomes for Reactions Reported for ADVIL LIQUI-GELS

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1508
2	Patient recovered	199
3	Patient has not recovered/symtoms have not resolved	103
4	Patient is recovering/symptoms resolving	78
5	Patient died	2

Search all MedWatch and FAERS by keyword:

ADVIL LIQUI-GELS Total Reports

Male	Female	Unknown	Total
1038	2443	740	4,221

Top Countries Reporting

	Country	Number of Reports
1	United States	1654
2	Canada	35
3	Puerto Rico	2
4	United Kingdom	1
5	Israel	1
6	Turkey	1

Outcomes for Reports

Serious: 1399
Not Serious: 2820
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

Product used for unknown indication
Headache
Back pain
Arthritis
Pain

Top Companies Reporting

Haleon PLC

Safety-Related FDA Updates

ADVIL LIQUI-GELS (IBUPROFEN POTASSIUM) Over-the-counter Drug:
Safety-related Labeling Changes

Have experience (good or bad) with ADVIL LIQUI-GELS? Rate ADVIL LIQUI-GELS at Ask a Patient.

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 ADVIL LIQUI-GELS 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.