Last update Feb. 4, 2021


Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Non-steroidal anti-inflammatory drug (NSAID) derived from pyrazolone. It also has antipyretic and analgesic properties.
Effective in the treatment of almost all osteoarticular conditions. Due to its hematological toxicity, it should be reserved as a second-line drug when other drugs have failed.
Oral or topical cutaneous administration maximum one week.

Since the last update we have not found any published data on its excretion in breast milk.

Its pharmacokinetic data (high percentage of protein binding and low pKa) makes transfer into breastmilk in significant quantities unlikely.

Only negligible absorption was seen following application of phenylbutazone to the skin of humans (Aarbakke 1978). The dermatological use of phenylbutazone is compatible with breastfeeding.

Due to its serious possible side effects, it has been withdrawn from the market in many countries.

American Academy of Pediatrics: medication usually compatible with breastfeeding (AAP 2001).

Until there is further published data on this drug in relation to breastfeeding, known safer alternatives may be preferable, especially during the neonatal period and in cases of prematurity.


  • Diclofenac (Safe substance and/or breastfeeding is the best option.)
  • Ibuprofen (Safe substance and/or breastfeeding is the best option.)
  • Prednisolone (Safe substance and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Phenylbutazone is also known as

Phenylbutazone in other languages or writings:


Main tradenames from several countries containing Phenylbutazone in its composition:


Variable Value Unit
Oral Bioavail. 100 (derm: ≈ 0) %
Molecular weight 308 daltons
Protein Binding 98 %
VD 0.17 ± 0.02 l/Kg
pKa 5.13 -
Tmax 2 hours
70 (29 - 175) hours


  1. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  2. Aarbakke J. Clinical pharmacokinetics of phenylbutazone. Clin Pharmacokinet. 1978 Sep-Oct;3(5):369-80. Review. Abstract

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