Drug Safety Information for ADVIL LIQUI-GELS (Ibuprofen)

FDA Safety Communication for ADVIL (IBUPROFEN) Over-the-counter Drug: FDA Link

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid; NSAIDs may cause rare kidney problems in unborn babies

Safety-related Labeling Changes for MOTRIN IB (IBUPROFEN) Discontinued Drug: FDA Link

Safety-related Labeling Changes for ADVIL COLD AND SINUS (IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for SINE-AID IB (IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for JUNIOR STRENGTH ADVIL (IBUPROFEN) Over-the-counter Drug: FDA Link

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

Safety-related Labeling Changes for CHILDREN'S MOTRIN (IBUPROFEN) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for CHILDREN'S ADVIL (IBUPROFEN) Rx Drug: FDA Link

Safety-related Labeling Changes for JUNIOR STRENGTH MOTRIN (IBUPROFEN) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for PEDIATRIC ADVIL (IBUPROFEN) Discontinued Drug: FDA Link

Safety-related Labeling Changes for MIDOL LIQUID GELS (IBUPROFEN) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for CALDOLOR (IBUPROFEN) Rx Drug: FDA Link

Safety-related Labeling Changes for ADVIL CONGESTION RELIEF (IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for ADVIL (IBUPROFEN) Over-the-counter Drug: FDA Link

Adverse Drug Reactions for ADVIL LIQUI-GELS* (Ibuprofen)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ADVIL LIQUI-GELS
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective4845
2Pain*3980
3Nausea3836
4Headache*2983
5Vomiting2962
6Dyspnoea2756
7Fatigue2564
8Dizziness2502
9Anxiety2261
10Diarrhoea2175
11Pyrexia1965
12Depression1762
13Chest pain1697
14Arthralgia1696
15Pain in extremity*1687
16Abdominal pain1676
17Asthenia1655
18Abdominal pain upper1653
19Injury1564
20Back pain*1547

* This side effect also appears in "Top 10 Side Effects of ADVIL LIQUI-GELS " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ADVIL LIQUI-GELS
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication23287
2Pain*20792
3Headache*8092
4Pyrexia*5859
5Back pain*3846
6Arthralgia3506
7Arthritis2961
8Premedication2534
9Osteoarthritis1959
10Analgesic therapy1815

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ADVIL LIQUI-GELS

Total Reports Filed with FDA: 281987


Number of FDA Adverse Event Reports by Patient Age for ADVIL LIQUI-GELS

Total Reports Filed with FDA: 281987*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ibuprofen (Advil extra strength, Tab-profen, Ibumetin, Aches-n-pain, Ibu-tab 200, Motrin ib sinus, Ibuprohm, Junifen, Being well ibuprofen, Care one ibuprofen, Cedaprin, Conney ibuprofen, Dover addaprin, Equaline ibuprofen, Formu care ibuprofen, Leader ibuprofen, Childrens ibuprofen, Medi-first ibuprofen, Medique i-prin, Otis clapp ultraprin, Pediacare childrens, Pediacare infants, Perrigo ibuprofen, Profen ib, Rexall ibuprofen, Rx act ibuprofen, Sunmark ibuprofen, Sunmark ibuprofen ib, Topcare ibuprofen, Up and up ibuprofen, Advil migraine, Caldolor, Aprofen, Dye free ibuprofen, Ibutab, Infants motrin, Moorebrand ibuprofen, Probufen, Proprinal, Good sense ibuprofen, Advil, Ibuprofen 200, Infants advil, Shoprite ibuprofen, Shoprite ibuprophen, Pediatric advil, Ibuprin, Ibuprofen ib, Children's elixsure, Motrin migraine pain, Ibuprofen softgels, Brufen retard, Fenbid, Midol liquid gels, Dolgesic, Childrens advil, Motrin ib, Ibuprofen (nsaid), Ibuleve, 7 select ibuprofen, Prastera - ibuprofen, Children's advil, Cuprofen, Proflex, Infants ibuprofen, Brufen, Equate ibuprofen, Childrens motrin, Children's ibuprofen, Medipren, Dolex, Anadin ibuprofen, Ibu-tab, Profen, Ibuprofen, Nuprin, Cap-profen, Ibu, Midol, Rufen, Inoven, Motrin, Children's motrin, Advil liqui-gels)

Charts are based on 281987 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ADVIL LIQUI-GELS Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.