General considerations

It is important to complete an individual risk assessment for your patient and to apply the principles of prescribing in breastfeeding when looking at the available information and making treatment decisions.

This article covers paracetamol—one of the most commonly used medicines for pain. It also covers various combination paracetamol products which are available with other ingredients.

Many other analgesics can also be considered in breastfeeding. See guidance on non-steroidal anti-inflammatory drugs, weak opioids, and strong opioid analgesics.

Recommendations

Paracetamol is the analgesic of choice for treating mild to moderate pain during breastfeeding.

Although some paracetamol combination products can be used while breastfeeding, many are not advised. Not only are some of the combination ingredients themselves not recommended in breastfeeding, but if side effects were to occur, it becomes more difficult to establish the cause.

Paracetamol

Preferred choice

Paracetamol is the preferred choice analgesic during breastfeeding as only small amounts pass into breast milk.

Infant monitoring

As a precaution, monitor infants for diarrhoea and vomiting.

Further information

There is very little published evidence for its use during breastfeeding. However, small amounts of paracetamol pass into the breast milk but this is far below the doses that would normally be given to infants directly.

The properties of paracetamol are such that at therapeutic doses, there is no risk of it accumulating in the infant’s system. There is potential for liver toxicity if there has been a maternal overdose, however management of this scenario would require specialist advice.

There have been no side effects reported in infants exposed to paracetamol through breast milk, except for one isolated case report of a hypersensitivity reaction. However, given the length of time that paracetamol has been available, and its widespread use, the risk of such a reaction happening is extremely rare.

Paracetamol combination products

If a combination product is used while breastfeeding, the safety of all the ingredients should be considered. Many of these products are available to self-select over the counter. Some of the combination products are listed below, but not all of the combinations available are included.

Patient Information

The NHS website provides advice for patients on the use of specific medicines in breastfeeding.

Contact us

Get in touch with the UK Drugs In Lactation Advisory Service (UKDILAS), our specialist breastfeeding medicines advice service if you need support in the following situations:

• you need further advice
• the medicine in question is not included here
• the infant is unwell or premature
• multiple medicines are being taken

About our recommendations

Recommendations are based on published evidence where available. However, evidence is generally very poor and limited, and can require professional interpretation. Assessments are often based on reviewing case reports which can be conflicting and lack detail.

If there is no published clinical evidence, assessments are based on: pharmacodynamic and pharmacokinetic principles, extrapolation from similar drugs, risk assessment of normal clinical use, expert advice, and unpublished data. Simulated data is now increasingly being used due to the ethical difficulties around gathering good quality evidence in this area.

Bibliography

Full referencing is available on request.

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