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What the label lists and what reports show

Bupivacaine and meloxicam side effects

Bupivacaine and meloxicam's FDA label: “Most common adverse reactions (incidence ≥5%) are: Soft tissue procedures: vomiting ( 6.1 ).” FAERS holds 196 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is wound dehiscence (29 reports).

  • No generic listed
  • Boxed warning

Check it at the source: the bupivacaine and meloxicam FDA label on DailyMed (effective April 20, 2026, Heron Therapeutics, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence ≥5%) are: Soft tissue procedures: vomiting ( 6.1 ).

Table 4. Adverse Reactions with ZYNRELEF in Study 3 (Total Knee Arthroplasty) Occurring with ≥5% Incidence and Higher than with Saline Placebo

Preferred TermSaline Placebo (N=53), %Bupivacaine HCl 125 mg (N=55), %ZYNRELEF 400 mg/12 mg (N=58), %
Nausea475550
Constipation233324
Vomiting192726
Hypertension151319
Pyrexia41514
Leukocytosis027
Pruritis257
Headache077
Anemia205
Hyperhidrosis405
Hypotension425

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following serious adverse reactions have been associated with bupivacaine HCl or meloxicam and are discussed in greater detail in other sections of the labeling: Cardiovascular System Reactions [see Warnings and Precautions (5.1 , 5.4) ] Gastrointestinal Bleeding, Ulceration, and Perforation [see Warnings and Precautions (5.2) ] Dose-Related Toxicity [see Warnings and Precautions (5.3) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Hypertension [see Warnings and Precautions (5.6) ] Heart Failure and Edema [see Warnings and Precautions (5.7) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.8) ] Anaphylactic Reactions [see Warnings and Precautions (5.9) ] Chondrolysis [see Warnings and Precautions (5.11) ] Methemoglobinemia [see Warnings and Precautions (5.12) ] Exacerbation of Asthma Related to Aspirin Sensitivity [see Warnings and Precautions (5.13) ] Serious Skin Reactions [see Warnings and Precautions (5.14) ] Drug Reaction with Eosinophilia and Systemic Toxicity (DRESS) [see Warnings and Precautions (5.15) ] Fetal Toxicity [see Warnings and Precautions (5.16) ] Hematologic Toxicity [see Warnings and Precautions (5.17) ] Most common adverse reactions (incidence ≥5%) are: Soft tissue procedures: vomiting ( 6.1 ). Orthopedic procedures: constipation and headache ( 6.1 ).

Source: FDA drug label, Heron Therapeutics, Inc., effective April 20, 2026 (SPL set dab484a7-9353-43ba-9e74-7fab910c712b), via openFDA; the full label on DailyMed

What do FAERS reports show?

196 reports list bupivacaine and meloxicam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 14 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Wound Dehiscence (named in the label)29
  • Suture Related Complication18
  • Seroma12
  • Wound Necrosis (named in the label)12
  • Procedural Nausea11
  • Blister10
  • Pain10
  • Product Odour Abnormal10
  • Skin Odour Abnormal10
  • Nausea (named in the label)9
  • No Adverse Event (a use or a product term, not a reaction)8
  • Post Procedural Drainage (named in the label)8
  • Rash (named in the label)8
  • Drug Ineffective (a use or a product term, not a reaction)7
  • Erythema (named in the label)7
  • Wound Drainage7
  • Fall6
  • Hypotension (named in the label)6
  • Impaired Healing (named in the label)6
  • Off Label Use (a use or a product term, not a reaction)6
  • Peroneal Nerve Palsy6
  • Bloody Discharge5
  • Dizziness Postural5
  • Cellulitis (named in the label)4
  • Hypoaesthesia4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Bupivacaine and meloxicam: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions