Zerodol (Diclofenac) Safety in Lactating Mothers
Diclofenac can be used during breastfeeding as it transfers into breast milk in minimal amounts, but it should be used at the lowest effective dose for the shortest duration possible, with particular caution in mothers of infants less than 6 weeks of age.
FDA-Approved Labeling Information
The FDA label for diclofenac states that the drug may be present in human milk, though in very low concentrations 1:
- One study found a milk diclofenac level of 100 mcg/L in a woman taking 150 mg/day orally, equivalent to an infant dose of approximately 0.03 mg/kg/day 1
- In 12 women using diclofenac (either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose postpartum), diclofenac was not detectable in breast milk 1
- The FDA recommends weighing the developmental and health benefits of breastfeeding against the mother's clinical need for diclofenac and any potential adverse effects on the breastfed infant 1
Clinical Guidelines and Evidence
NSAIDs including diclofenac are considered safe alternatives during breastfeeding according to multiple sources:
- The Association of Anaesthetists 2020 guidelines list diclofenac as a safe NSAID option for breastfeeding women, similar to ketorolac and ibuprofen 2
- Short-term use of NSAIDs is compatible with breastfeeding, with preference for short-acting agents without active metabolites like ibuprofen for long-term treatment 3
- Acetaminophen and ibuprofen are the preferred analgesics during lactation, though NSAIDs as a class are generally acceptable 4
Practical Recommendations
When prescribing diclofenac to a lactating mother:
- Use the lowest effective maternal dose to minimize infant exposure 3, 5
- Consider timing doses before the infant's longest sleep interval to reduce exposure during breastfeeding 4
- Short-term treatment with NSAIDs at the low end of the recommended dosage range is appropriate 5
- For long-term pain management, consider switching to ibuprofen as it may be preferable due to its shorter half-life and lack of active metabolites 3
Important Caveats
Special populations requiring extra caution:
- Infants less than 6 weeks of age (corrected for gestation) have immature hepatic and renal function and may be more vulnerable to NSAID exposure 2
- Premature infants and those with neonatal diseases or inherited metabolic disturbances may be at higher risk from drug exposure through breast milk 6
- Monitor the infant for any signs of adverse effects, though these are rare with NSAIDs at therapeutic doses 7
Risk-Benefit Analysis
The amount of diclofenac transferred to breast milk is generally too small to cause clinically significant effects in most infants 1. The many health advantages of breastfeeding typically outweigh the minimal theoretical risks from maternal NSAID use 3, 5. Breastfeeding should not be interrupted for short-term diclofenac use in most circumstances 5.