Treating Fever and/or Pain is Safe with IV Ibuprofen
10 Apr, 23
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Ibuprofen is the only intravenous (IV) nonsteroidal anti-inflammatory drug (NSAID) approved for the reduction of fever in adults in the USA. Another IV NSAID is ketorolac injection, but its use is associated with gastrointestinal complications. IV diclofenac sodium is another NSAID, but it is contraindicated in patients with moderate to severe renal insufficiency. Neither of these NSAIDS are indicated for the treatment of fever. There is paucity of data on the use of IV ibuprofen in hospitalized patients.




This review presents cumulative analysis of clinical safety of IV ibuprofen for the treatment of pain and/or fever in hospitalized adults as assessed in ten clinical studies.




Study Design

  • Integrated safety analysis of ten Phase II-IV clinical studies


Treatment Strategy

  • The safety cohort comprised 1,752 adult patients; out of which 1,220 (69.6%) received IV ibuprofen, 452 (25.8%) received placebo and 80 received IV ketorolac

  • Doses of IV ibuprofen ranged from 100 to 400 mg for the indication of fever and up to 800 mg for pain

  • A validated 10-point Visual Analog Scale (VAS) was used to evaluate pain

  • Reasons for pain were both surgical and nonsurgical

  • Fever was defined as a core body temperature of 38°C (100.4°F) or above

  • Safety was compared based on the incidence and severity of treatment-emergent AEs as well as changes in vital signs and laboratory parameters



  • The incidence of at least 1 AE was lower in IV ibuprofen group as compared to placebo (60% vs 85%), with majority of these being mild or moderate

  • The most common AEs were nausea, vomiting, constipation and flatulence in both groups

  • Infusion-site pain was the only most frequent AE associated with IV ibuprofen

  • The incidence of AEs was lower in the ibuprofen group than placebo among elderly patients >65 years (59% vs 94%)

  • The incidence of markedly abnormal vital signs were similar in both groups

  • Proportion of patients with SAEs was similar (5% vs 4%)

  • There was no elevated risk of bleeding event or hematological effect with the administration of IV ibuprofen

  • IV ibuprofen had similar effects on the renal function as placebo-treated group

  • IV ibuprofen has been well tolerated by hospitalized and outpatient patients when administered both prior to surgery and postoperatively as well as for nonsurgical pain or fever. 



  • Intravenous ibuprofen demonstrated a favorable safety profile, with lesser adverse events and require less morphine as compared to those receiving placebo

  • IV ibuprofen can be safely administered prior to surgery and continued in the postoperative period as a component of multimodal pain management in hospitalized adults.


J Pain Res. 2015 Oct 23;8:753-65. Doi: 10.2147/JPR.S93547.