TheraRadar
Data updated: Sep 20, 2026

IBUPROFEN · TRIS PHARMA INC

Generic · see CALDOLOR Cyclooxygenase Inhibitors
Pain Approved 1974-09-19

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
118
Indications
--
Phase 3 Trials
52
Years on Market

Details

Status
Prescription
First Approved
1974-09-19
Routes
ORAL
Dosage Forms
SUSPENSION/DROPS, CAPSULE, TABLET, SUSPENSION, TABLET, CHEWABLE

Companies

TRIS PHARMA INC MARKSANS PHARMA WATSON LABS Sun Pharma HALSEY PH HEALTH ABBOTT PUREPAC PHARM PERRIGO ADAPTIS Teva Dr. Reddy's STRIDES PHARMA SUN PHARMA CANADA ANNORA PHARMA J AND J CONSUMER INC ANI PHARMS IVAX SUB TEVA PHARMS STRIDES PHARMA INTL Novartis LNK ASCENT PHARMS INC Aurobindo Pharma PAR PHARM AMNEAL PHARMS NY CONTRACT PHARMACAL BIONPHARMA GRANULES HUMANWELL PURACAP SUPERPHARM P AND L DEV LLC RISING PLIVA ARISE SHANDONG XINHUA ULTRATAB LABS INC OHM LABS INC NORTHSTAR HLTHCARE SUNSHINE GUARDIAN DRUG YICHANG HUMANWELL LEDERLE AMNEAL PHARMS SOFGEN PHARMS PAI HOLDINGS PHARM MCNEIL MERRO PHARM LEINER P AND L L PERRIGO CO PATHEON SOFTGELS ALLIED PHARMAZONE AVEMA PHARMA PERRIGO R AND D ALKEM LABS LTD PADAGIS US GRANULES INDIA ONESOURCE RUBICON RESEARCH
Active Ingredient: IBUPROFEN

IBUPROFEN Approval History

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Original
New Indication
New Form
Label Update
1566 FDA actions from 1985 to 2026
Aug 2026 SUPPL
Mfg · Manufacturing (CMC)
Mar 2026 ORIGINAL
Update
Apr 2025 SUPPL
Mfg · Manufacturing (CMC)

What IBUPROFEN Treats

2 indications

IBUPROFEN is approved for 2 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as CALDOLOR (same active ingredient).

Source: FDA Label

IBUPROFEN Boxed Warning

Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ]. Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications and Warnings ]. Gastrointestinal Risk NSAIDs cause an i...

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Clinical Trial Registry

195 trials
Trial Sponsor ID Phase Status Title
NCT07571252 2603555595 Ph 4 recruiting Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery
NCT07565012 DIPI-PEP AFID-OPER-PEP-2025-01 IRB Approval Number Ph 4 completed Comparative Evaluation of Diclofenac Sodium and Ibuprofen for Post-Endodontic Pain Management
NCT03759028 IRB# 18-001158 Ph 4 recruiting Supracondylar Post-Operative Pain Study
NCT06757075 H-001FC Ph 4 recruiting Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
NCT06187584 results posted STUDY00000286 Ph 4 completed Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management
NCT06671002 CARES for Kids HUM00252793 BPS-2023C1-32147 Ph 4 recruiting Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial
NCT03974932 results posted HTX-011-306 Ph 3 completed Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
NCT03695367 results posted HTX-011-215 Ph 2 completed Phase 2 Herniorrhaphy Study for Opioid Elimination
NCT06686862 INFLAMA 2024-513803-15-00 2024-513803-15-00 Ph 3 recruiting Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis
NCT05488847 results posted 15592 Ph 4 active not recruiting Opioid-Free Pain Protocol After Shoulder Arthroplasty
NCT05640674 results posted 52475 Ph 4 terminated Post-operative Pain Management in Children With Supracondylar Humerus Fractures
NCT04681105 20472 NCI-2020-08118, 20472 Ph 1 completed Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies
NCT05575700 PERISAFE 001CCWL2022 Ph 4 completed Safety of Ibuprofen After Major Orthopaedic Surgeries
NCT04037514 IBUPAR IBUPAR-TRIAL Ph 3 completed Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus
NCT02477007 MORPHAPAIN P130921 2015-001458-14 Ph 3 completed Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children
NCT06434233 IRB00308549 Ph 4 recruiting Opioid Use After Laparoscopic Salpingectomy
NCT03493945 results posted 180078 18-C-0078 Ph 1, Ph 2 completed Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)
NCT03055247 XCGD-MOBI 2015-002356-27 Ph 2 recruiting Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD
NCT05842044 No-PAIN 20220783 Ph 2 recruiting NSAID Use After Robotic Partial Nephrectomy
NCT02330926 MENAC MENAC-2013-05 2013-002282-19 Ph 3 completed Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
NCT05012098 results posted 10000030 000030-C Ph 2 completed Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).
NCT03893175 832417 Ph 1 completed Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction
NCT06786650 2024-KAEK-18 Ph 4 active not recruiting Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack
NCT05076110 results posted 21-003441 Ph 4 completed Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
NCT03060434 Pento-LR Ph 4 active not recruiting Pentoxifylline and Lumbar Radiculopathy
NCT05750264 2/2023 ANET10-1 Ph 2 active not recruiting Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy
NCT06948513 1344913 Ph 3 completed Effect of Over-the-counter Analgesics on Postoperative Pain
NCT06061575 Management of Fever in Sepsis Ph 4 completed Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients
NCT02571543 Ibudelay 015/15 Ph 2 completed Can Ibuprofen Delay Ovulation in Natural Cycle-IVF?
NCT03648437 PAI 38/2018 Ph 1 terminated Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus
NCT03767933 No OUCH Pro00073476 Ph 2 completed Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries
NCT03749616 Adult NSAID results posted 2009129 Ph 4 terminated Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture
NCT04879823 results posted STUDY20120036 Ph 3 terminated Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity
NCT03929640 MOPAC results posted 00010393 Ph 3 terminated Management Of Pain After Cesarean Trial
NCT04791761 results posted STUDY19040036 (Part 2) Ph 1, Ph 2 terminated Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy
NCT06531707 SIL-30700-III-23(1) Ph 3 recruiting Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
NCT04646967 REB20-1076 Ph 2 completed An Evaluation of Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision
NCT06505148 024-301 Ph 4 not yet recruiting Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
NCT06077786 20435A 2023-503987-18-00 Ph 1 completed A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult Participants
NCT05011149 SMART-PDA 459750 Ph 3 recruiting Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT
NCT01670656 results posted P08257 2012-002449-40, MK-8175A/MK-8342B-057 Ph 2 completed A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)
NCT02668783 results posted 8342B-059 2015-004325-14 Ph 3 terminated Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in Women With Primary Dysmenorrhea (With Optional Extension) (MK-8342B-059)
NCT02668822 results posted 8342B-060 2015-004326-34 Ph 3 terminated Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in the Treatment of Women With Primary Dysmenorrhea (MK-8342B-060)
NCT03949478 TPS-1.0 Ph 2 recruiting Treating Postictal Symptoms Using Ibuprofen and Nifedipine
NCT02276911 13BN033 Ph 2 terminated Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery
NCT02929589 results posted FWH20160095H Ph 3 terminated Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy
NCT03571737 results posted UMCIRB 17-001594 Ph 3 completed Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department
NCT03399318 results posted RSRB00067717 R01NS102176 Ph 2 completed Aggressive Antipyretics for Fever Reduction in CNS Malaria
NCT06231212 TMD ECa233 CRP6305031970 Ph 2, Ph 3 completed Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder
NCT06232785 2021/018 Ph 4 completed Gynecologic Endoscopic Surgery of Female Motion Sickness Patients

Showing 50 of 195 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

IBUPROFEN FDA Label Details

Indications & Usage

FDA Label (PDF)

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprof...

⚠️ BOXED WARNING

Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnin...

Looking for the branded version?

CALDOLOR

Full clinical data, patents, trials, and competitive landscape for ibuprofen.

See CALDOLOR

Data Sources

FDA Approval: ANDA079058 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.