ADVIL LIQUI-GELS FDA MedWatch Direct Reports Summary

These tables and charts are created from 9 voluntary U.S. reports for ADVIL LIQUI-GELS (IBUPROFEN) 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 ADVIL LIQUI-GELS Report.

Top Adverse Effects Associated with ADVIL LIQUI-GELS (from U.S. FDA Medwatch Reports)

 Side Effect# of FDA Reports
1HYPERSENSITIVITY2
2MUSCLE SPASMS2
3NAUSEA2
4ITCHING2
5ABNORMAL DREAMS1
6ANGIOEDEMA1
7ANXIETY1
8JOINT PAIN1
9LACK OF STRENGTH AND ENERGY (ASTHENIA)1
10BURNING SENSATION1
11CONGESTIVE HEART FAILURE1
12CONFUSIONAL STATE1
13DISCOMFORT1
14DISTURBANCE IN ATTENTION1
15DIZZINESS1
16SLURRED SPEECH1
17SKIN REDNESS1
18FATIGUE1
19FLATULENCE1
20GAIT DISTURBANCE1
21LOW BLOOD PRESSURE1
22IMPAIRED WORK ABILITY1
23INSOMNIA1
24MEMORY IMPAIRMENT1
25MIGRAINE1
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ADVIL LIQUI-GELS Total Medwatch Safety Reports by Patient Sex

 Male    Female    Unknown    Total  
 4    4        9  

Medwatch Reporter TypeCount
Consumer6
Other Health Professional1

Top Indications      
Product used for unknown indication
Headache
Back pain
Arthritis
Pain

Type of Outcome Reported
Serious: 8
Not Serious: 1
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: 9
Concomitant Drugs: 5
Note: A single MedWatch report can list more than one drug. This summary includes ADVIL LIQUI-GELS identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

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


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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.