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hydrocodone + ibuprofen (Ibudone)

✓ Approved

Kowa · OPRM1 · Small Molecule

What is hydrocodone + ibuprofen?

hydrocodone + ibuprofen is a small molecule developed by Kowa. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesIbudone
CompanyKowa
Drug ClassSmall Molecule
Molecular TargetOPRM1, PTGS1, PTGS2
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Kowa

Mechanism of Action

Molecular Targets

hydrocodone + ibuprofen acts on 3 molecular targets:

OPRM1opioid receptor mu 1 (MOR, MOP)
PTGS1prostaglandin-endoperoxide synthase 1 (PGHS-1, PTGHS)
PTGS2prostaglandin-endoperoxide synthase 2 (COX-2, COX2)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

hydrocodone + ibuprofen is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Gastrointestinal disordersAbdominal pain✓ Approved

Related Research Articles

PubMedAllergologia et immunopathologia2026-09-19

Systematic allergological evaluation enables NSAID allergy delabeling and identification of safe alternatives in adults.

Guzmán Avilán Rosa I RI, Avilés Vargas Silvia Rosario SR, González Díaz Sandra N SN, Ortega Natalhie Acuña NA et al.

Hypersensitivity reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) are a frequent reason for allergy referral and a major diagnostic challenge. In everyday practice, overdiagnosis contributes to unnecessary drug avoidance, restricting therapeutic access to first-line analgesic and anti-inflammatory treatments and impacting clinical care. To determine the true prevalence of confirmed NSAID hypersensitivity in adults with suspected reactions through systematic allergological evaluation and assess its clinical impact on therapeutic access through safe delabeling and identification of alternative agents. We conducted a prospective, cross-sectional study including adults ≥18 years with suspected NSAID hypersensitivity evaluated at a tertiary referral center in Mexico between March and November 2025. All patients underwent standardized assessment including detailed clinical history, skin testing (prick and intradermal), and controlled drug provocation tests (DPTs) with acetylsalicylic acid, the implicated NSAID, and celecoxib. Clinical phenotypes were classified according to EAACI/ENDA guidelines. Associations between clinical variables and confirmed hypersensitivity were analyzed. Thirty-three patients were included; 72.7% were women, and 42.4% were aged 18-30 years. Atopy was present in 63.6%. Urticaria/angioedema predominated (69.7%). Ibuprofen and diclofenac were most frequently implicated (45.5%). Skin testing showed low diagnostic yield (6.1% prick; 21.2% intradermal). DPT was positive in 24.2%, mainly inducing urticaria. Celecoxib was tolerated in all patients with multiple hypersensitivity. Overall, 48.5% had no confirmed hypersensitivity and were successfully delabeled, restoring access to NSAID therapy. Multiple hypersensitivity occurred in 39.4% and selective reactions in 12.1%, with NIUAA as the predominant phenotype (33.4%). Atopy (p = 0.002) and recurrent episodes (p < 0.001) were associated with multiple hypersensitivity. Nearly half of adults labeled as NSAID-allergic were not truly hypersensitive. These prospective Mexican data demonstrate the clinical impact of systematic evaluation in reducing overdiagnosis and improving therapeutic access.

PMID 42760878
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PubMedFrontiers in pharmacology2026-09-18

Suspected NIUAA after indobufen in a patient with ibuprofen allergy: a case report suggesting possible cross-reactivity.

Luo Long L, Li Jun J, Yuan Ying Y, Zhu Ling L

Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used in clinical practice, and hypersensitivity reactions to them are not uncommon. Although ibuprofen and indobufen have different clinical indications, both exert their effects through cyclooxygenase inhibition, suggesting a potential risk of cross-reactivity. This report describes a 52-year-old female patient who experienced pruritus, facial and eyelid edema, tearing, and ocular itching approximately half an hour after two separate exposures to ibuprofen in the past. During the current hospitalization for cerebral infarction, she received indobufen for antiplatelet therapy and developed similar symptoms-eyelid edema, tearing, and pruritus of the head and face-within approximately 10 min. The suspected drug was discontinued and antihistamine therapy was administered, following which the symptoms resolved. Subsequent continued use of other concomitant medications, along with antiplatelet therapy with clopidogrel and cilostazol, did not elicit any allergic reactions; this case suggests indobufen as a possible culprit allergen, and its shared COX-1 inhibitory mechanism with ibuprofen-despite their different chemical groups-raises the possibility of cross-reactive hypersensitivity between the two agents, although this inference remains to be confirmed. Although allergic reactions to indobufen are rare in clinical practice, clinicians should remain vigilant about the potential risk of cross-reactivity when prescribing indobufen to patients with a history of NSAID hypersensitivity.

PMID 42755679
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PubMedInternational journal of clinical pediatric dentistry2026-09-18

Effect of Occlusal Reduction on Pain in Posterior Teeth with Necrosis and Apical Periodontitis: A Randomized Controlled Trial.

Sangwan Pankaj P, Saini Hans Raj HR, Sangwan Aditi A

This randomized controlled trial evaluated the impact of occlusal reduction on postoperative pain after chemomechanical preparation. 102 asymptomatic teeth with pulp necrosis and apical periodontitis were randomly allocated to two equal groups: the control group (NOR) and the occlusal reduction (OR) group. The root canal treatment was performed according to a predefined standardized protocol. Patients were prescribed Ibuprofen 400 mg to be consumed 8 hourly, if required. Postoperative pain and analgesic consumption were documented for 7 days following chemomechanical preparation. The data analysis was performed using Mann-Whitney U and Chi-square tests. A significant postoperative pain difference was found between the two groups on the first 3 days, with higher pain observed in NOR as compared to OR (p < 0.05). The prevalence of pain was higher in NOR (47.06%) as compared to OR group (29.41%), but the difference was not significant (p > 0.05). No significant differences were observed in the mean number of analgesic doses consumed and the prevalence of analgesic intake between the two groups (p > 0.05). Postoperative pain incidence was comparable in the two groups. The difference in postoperative pain intensity was statistically significant on the first 3 days. The reduction observed, however, lacked clinical relevance. Sangwan P, Saini HR, Sangwan A. Effect of Occlusal Reduction on Pain in Posterior Teeth with Necrosis and Apical Periodontitis: A Randomized Controlled Trial. Int J Clin Pediatr Dent 2026;19(8):957-962.

PMID 42757289
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PubMedBMJ open2026-09-18

Safety of short-term non-steroidal anti-inflammatory drug use in the postoperative setting in paediatric patients with chronic kidney disease: protocol for a randomised, placebo-controlled trial.

Xiang Alice H AH, Hwang Catalina K CK, Clennon Emily E, To Thuytien T et al.

Non-steroidal anti-inflammatory drugs (NSAIDs) are a key component of multimodal analgesia in paediatric surgical care but are often avoided in patients with chronic kidney disease (CKD) due to concerns for nephrotoxicity. This trial aims to evaluate the safety of short-term NSAID use in paediatric patients with mild-to-moderate CKD undergoing inpatient urological surgery. This is a multicentre, double-blinded, randomised, placebo-controlled trial evaluating short-term NSAID use in paediatric patients with CKD stages 2-3a after urological surgeries requiring admission. This study is being conducted at two academic paediatric urology departments in the USA. Patients aged >18 months will be randomised 1:1 to receive ketorolac/ibuprofen or placebo for ≤5 days postoperatively. The primary outcome is acute kidney injury (AKI) as defined according to Kidney Disease: Improving Global Outcomes criteria based on serum creatinine trends and urine output. Secondary outcomes are postoperative pain scores and opioid use (reported as morphine equivalents/kg/day). Fisher's exact test will compare AKI rates between groups. The recruitment goal of 164 participants provides 80% power to detect a 20% absolute increase in AKI incidence (baseline AKI rate of 15% based on prior studies, two-sided testing). This study has been approved by the Colorado Multiple Institutional Review Board (COMIRB #24-1252) and will be conducted in accordance with institutional ethical guidelines. Written informed consent will be obtained from a parent or legal guardian for all participants, and child assent will be obtained when developmentally appropriate and required by institutional policy. Study findings will be disseminated through presentation at scientific meetings and publications in peer-reviewed journals. NCT06860711.

PMID 42760073
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PubMedRespirology case reports2026-09-17

Bilateral Bloody Pleural Effusions With Discordant Cellular Patterns: A Case of Concurrent Parapneumonic Effusion and Dressler Syndrome.

Narumi Yoshitsugu Y, Hoshino Susumu S, Yamakawa Midori M, Amano Yoshiko Y

Bilateral pleural effusions typically suggest systemic aetiologies; however, concurrent distinct localised pathologies are rare. A 73-year-old man presented with fever and cough. Chest imaging revealed pneumonia and bilateral pleural effusions developed during antibiotic treatment. The right effusion was neutrophil-dominant, consistent with parapneumonic effusion, while the left was lymphocyte-dominant, suggesting Dressler syndrome triggered by pneumonia-induced systemic inflammation. Both effusions were bloody, an appearance possibly exacerbated by the concomitant use of a direct oral anticoagulant and aspirin. The left effusion recurred months later but significantly improved following ibuprofen treatment, supporting an immune-mediated aetiology. This case highlights that bilateral effusions can arise from different aetiologies and that pneumonia-induced inflammation may trigger a latent immune response related to prior cardiac surgery.

PMID 42751579
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PubMedCornea2026-09-16

Low-Dose Mitomycin-C for Mucosal Overgrowth Treatment in Boston Type 1 Keratoprosthesis With Autologous Buccal Mucosa Overlay in a Patient With Severe Stevens-Johnson Syndrome.

Pastor Asensio Andrea A, Pons-Talaya Clara C, Andino Angulo Claudia C, Julio Morán Gemma G et al.

To describe the management of fast mucosal overgrowth by trimming it and application of a low concentration of mitomycin C (MMC) in a Boston Keratoprosthesis type I with buccal autologous mucosa overlay (B1KProM). We report a single-patient case in which low-dose, short-duration MMC was used. A review of the literature was performed to identify previously reported dosing strategies. A 21-year-old woman developed ibuprofen-induced Stevens-Johnson syndrome at age 5, resulting in severe ocular surface disease. Multiple surgeries performed on the right eye (RE) failed because of persistent epithelial defects and recurrent infections. The best-corrected visual acuity was 0.08 (decimal) in the RE. A B1KProM was implanted on the RE but after 2 weeks mucosa overgrown, partially obstructing the visual axis. A resection of the mucosal excess plus application of a sponge soaked in MMC 0.01% for 1 minute was performed to prevent recurrence. The intervention successfully restored the visual axis preserving buccal mucosa integration during the 12 months of follow-up. In this period, no MMC complications were found and the best-corrected visual acuity improved to 0.6. The prosthesis remained in place without additional postoperative complications. Mucosal overgrowth is a frequent complication after B1KProM, particularly in eyes with Stevens-Johnson syndrome. This report provides initial evidence that the complication could be successfully treated with mucosal excision and a lower dose of MMC, to prevent recurrence, avoiding side effects, and to improve prosthesis retention, usually shorter in patients with autoimmune disease.

PMID 42746721
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