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What the label lists and what reports show

Piperacillin and tazobactam side effects

Piperacillin and tazobactam's FDA label: “The most common adverse reactions (incidence >5%) are diarrhea, constipation, nausea, headache, and insomnia.” FAERS holds 33,494 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 acute kidney injury (2,410 reports).

  • Generic listed
  • A presentation discontinued

Check it at the source: the piperacillin and tazobactam FDA label on DailyMed (effective July 21, 2025, ONESOURCE SPECIALTY PHARMA LIMITED); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions (incidence >5%) are diarrhea, constipation, nausea, headache, and insomnia.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Adverse Reactions [see Warnings and Precautions (5.1)] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)] • Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.3)] • Rhabdomyolysis [see Warnings and Precautions (5.4)] • Hematologic Adverse Reactions [see Warnings and Precautions (5.5)] • Central Nervous System Adverse Reactions [see Warnings and Precautions (5.6)] • Nephrotoxicity in Critically Ill Patients [see Warnings and Precautions (5.7)] • Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions (5.9)] The most common adverse reactions (incidence >5%) are diarrhea, constipation, nausea, headache, and insomnia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Onesource at 1-888-217-8103 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

Source: FDA drug label, ONESOURCE SPECIALTY PHARMA LIMITED, effective July 21, 2025 (SPL set 28258745-12e4-4f0f-b318-4a1a1bebc928), via openFDA; the full label on DailyMed

What do FAERS reports show?

33,494 reports list piperacillin and tazobactam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,155 are coded as a death and 19,903 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 20 reactions below, 13 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.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)3,153
  • Off Label Use (a use or a product term, not a reaction)2,788
  • Acute Kidney Injury (named in the label)2,410
  • Pyrexia2,304
  • Pneumonia (a use or a product term, not a reaction)1,528
  • Diarrhoea (named in the label)1,440
  • Thrombocytopenia (named in the label)1,292
  • Sepsis1,263
  • Condition Aggravated (a use or a product term, not a reaction)1,235
  • Febrile Neutropenia1,141
  • Neutropenia (named in the label)1,128
  • Dyspnoea1,118
  • Rash (named in the label)1,113
  • Hypotension (named in the label)1,038
  • Nausea (named in the label)1,003
  • Septic Shock987
  • Drug Reaction With Eosinophilia And Systemic Symptoms (named in the label)963
  • Respiratory Failure932
  • Vomiting (named in the label)907
  • Drug Interaction (a use or a product term, not a reaction)857
  • Anaemia (named in the label)839
  • Multiple Organ Dysfunction Syndrome745
  • Renal Failure (named in the label)742
  • Pancytopenia (named in the label)697
  • Abdominal Pain (named in the label)684

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

What next?

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