UNASSIGNED: Abstract Background: @entity5018 ( @entity12690 ) is an efficacious over-the-counter analgesic/antipyretic with adverse event (AE) rates comparable to placebo. @entity12690 @entity1372 (IBUNa) is a newer, more soluble form that is absorbed faster than standard @entity12690 , leading to more rapid analgesia. Although its safety and tolerability are expected to be comparable to standard @entity12690 , this has not yet been reported. Methods: Pooled analysis comparing the safety of single-dose IBUNa (512 mg; equivalent to 400 mg @entity12690 free acid; n = 362) with standard @entity12690 tablets (400 mg; n = 342) and placebo (n = 187) across five Phase III, randomized, placebo-controlled, double-blind studies evaluating IBUNa for treatment of postoperative dental @entity158 , @entity2701 , or @entity221 . Results: Treatment-emergent AEs (TEAEs) occurred in 5% of cases in the IBUNa group (25 events), 6.4% of cases in the standard @entity12690 group (41 events), and 10.2% of cases in the placebo group (31 events). The most frequent TEAEs were in the following Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes: @entity344 (2.8, 3.2, and 5.9% for IBUNa, standard @entity12690 , and placebo, respectively), @entity3002 (1.4, 3.5, and 3.7% for IBUNa, standard @entity12690 , and placebo, respectively), and general disorders and administration-site conditions (1.1, 1.5, and 2.1% for IBUNa, standard @entity12690 , and placebo, respectively). @entity390 was the most common TEAE (2.5, 2.6, and 5.9% for IBUNa, standard @entity12690 , and placebo, respectively). Only two AEs were considered related to treatment: @entity111 (n = 1, IBUNa) and @entity390 (n = 1, placebo). Of those subjects reporting >=  1 TEAE, 44.4, 36.4, and 89.5% of subjects in the IBUNa, standard @entity12690 , and placebo groups, respectively, received rescue medication. Conclusion: IBUNa has a favorable safety profile comparable to those of standard @entity12690 tablets and placebo in single-dose studies evaluating analgesic or antipyretic efficacy. ClinicalTrials.gov Registry Numbers: Dental @entity158 studies: NCT01098747 and NCT01216163; @entity10 studies: NCT01077973 and NCT01362491; pyresis study: NCT01035346.

Safety of a novel formulation of @entity5018 sodium compared with standard XXXX and placebo.

@entity390 :: ('MESH:D009325', 'Disease') :: ['Nausea', 'nausea'] @entity5018 :: ('MESH:D007052', 'Chemical') :: ['Ibuprofen'] @entity1372 :: ('MESH:D012964', 'Chemical') :: ['sodium'] @entity12690 :: ('CHEBI:30356', 'Chemical') :: ['IBU'] @entity344 :: ('MESH:D005767', 'Disease') :: ['gastrointestinal disorders'] @entity3002 :: ('MESH:D009421', 'Disease') :: ['nervous system disorders'] @entity111 :: ('MESH:D011537', 'Disease') :: ['pruritus'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity2701 :: ('MESH:D018781', 'Disease') :: ['tension-type headache'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache'] @entity221 :: ('MESH:D005334', 'Disease') :: ['fever']
@entity5018 :: (MESH:D007052,Chemical) :: ['ibuprofen']
