Safety of Tazobactam During Pregnancy

Piperacillin/tazobactam is compatible with pregnancy and can be safely used when clinically indicated, particularly during the first trimester. 1

Safety Profile

Piperacillin/tazobactam is classified as pregnancy category B1 (Australian classification) or B (FDA classification), indicating it is considered low risk in pregnancy 1
No teratogenic effects have been observed in animal studies with piperacillin/tazobactam 2
In humans, no cases of congenital defects have been reported with piperacillin/tazobactam use during pregnancy 1
The FDA drug label states that while piperacillin and tazobactam cross the placenta, there is no evidence of teratogenicity up to the highest doses evaluated in animal studies 2

The European Respiratory Society/TSANZ task force statement explicitly lists piperacillin/tazobactam as "compatible" for use during pre-conception and first trimester 1
Clinical experience with penicillins (including piperacillin/tazobactam) is extensive, and they are considered to have an overall good safety profile in pregnancy 3
All penicillins, including piperacillin/tazobactam, are generally considered low risk in pregnancy based on decades of clinical experience 1, 4

Piperacillin/tazobactam does cross the placenta and is present in breast milk 1, 2
During pregnancy, there may be increased volume of distribution and clearance of the drug, potentially requiring dosage adjustments 5
The drug has low oral bioavailability, although in premature infants and neonates there may be increased intestinal absorption 1

While generally safe, rare adverse effects have been reported, including a case of bone marrow suppression (leucopenia, neutropenia, and thrombocytopenia) in a pregnant woman after 15 days of treatment 6
Fetotoxicity in the presence of maternal toxicity was observed in animal studies at doses less than the maximum recommended human daily dose, but only with intraperitoneal administration (not the typical clinical route) 2
Monitor for potential side effects as you would in non-pregnant patients, with particular attention to hematological parameters with prolonged use 6, 4

When treating serious infections during pregnancy, the benefit of controlling the maternal infection with piperacillin/tazobactam typically outweighs potential risks 4
Penicillins, including piperacillin/tazobactam, should be considered first-line antibiotics during pregnancy when clinically indicated and appropriate for the infection being treated 4
For severe infections requiring broad-spectrum coverage, piperacillin/tazobactam is a safer choice compared to other broad-spectrum alternatives such as aminoglycosides, which should be avoided if possible during pregnancy 1, 4

Avoiding necessary antibiotic treatment due to unfounded concerns about fetal harm may put both mother and fetus at greater risk from untreated infection 4
Underdosing may occur due to physiological changes in pregnancy (increased volume of distribution and clearance) 5
Prolonged use without monitoring for potential hematological adverse effects 6