May 27 2022


Risks to the infant

The information available is limited to cases referred and small groups of patients. In general, it is not expected a significant concentration in the infant, even at relatively high doses (200-300 mg / day in the mother). It seems not to have been cases of adverse effects in children exposed to it through the milk.

The usual doses of the drug (up to 300 mg) produced a low concentration of fluvoxamine in milk and is unlikely to produce an undesirable effect, although in some isolated cases have been detected high levels of the substance.

Influence on breastfeeding

Fluvoxamine can increase prolactin and cause galactorrhea in non-lactating women. It is not know the possible influence of the drug on the nursing woman, but seems to have no significance.


Possible harmful effects of the drug on the infant are unknown, so, if given to the mother, the baby should be closely monitored.

Because there is not available a sufficient number of studies to ensure the safety of this medicine used during lactation, it is preferable to replace it by another antidepressant best known.


1.Kristensen JH, Hackett LP, Kohan R, Paech M, Ilett KF. The amount of fluvoxamine in milk is unlikely to be a cause of adverse effects in breastfed infants. J Hum Lact. 2002 May;18(2):139-43.
2.Piontek CM, Wisner KL, Perel JM, Peindl KS. Serum fluvoxamine levels in breastfed infants. J Clin Psychiatry. 2001 Feb;62(2):111-3.
3.Arnold LM, Suckow RF, Lichtenstein PK. Fluvoxamine concentrations in breast milk and in maternal and infant sera. J Clin Psychopharmacol. 2000 Aug;20(4):491-3.
4.Yoshida K, Smith B, Kumar RC. Fluvoxamine in breast-milk and infant development. Br J Clin Pharmacol. 1997 Aug;44(2):210-1.
5.Hendrick V, Fukuchi A, Altshuler L, Widawski M, Wertheimer A, Brunhuber MV. Use of sertraline, paroxetine and fluvoxamine by nursing women. Br J Psychiatry. 2001 Aug;179:163-6.
6.Hendrick V, Smith LM, Hwang S, Altshuler LL, Haynes D. Weight gain in breastfed infants of mothers taking antidepressant medications. J Clin Psychiatry. 2003Apr; 64(4):410-2.
7.Spigset O, Carleborg L, Hedenmalm K, Dahlqvist R. Effect of cigarette smoking on fluvoxamine pharmacokinetics in humans. Clin Pharmacol Ther. 1995 Oct;58(4):399-403.
8.Hagg S, Granberg K, Carleborg L. Excretion of fluvoxamine into breast milk. Br J Clin Pharmacol. 2000 Mar;49(3):286-8.
9.Wright S, Dawling S, Ashford JJ. Excretion of fluvoxamine in breast milk.Br J Clin Pharmacol. 1991 Feb;31(2):209.
10.Ressel G. AAP updates statement for transfer of drugs and other chemicals into breast milk. American Academy of Pediatrics. Am Fam Physician. 2002 Mar 1;65(5):979-80.
11.Gentile S. Quetiapine-fluvoxamine combination during pregnancy and while breastfeeding. Arch Womens Ment Health. 2006 May 8;
12.Gentile S. Quetiapine-fluvoxamine combination during pregnancy and while breastfeeding. Arch Womens Ment Health. 2006 May;9(3):158-9.

Warning of the manufacturer:

Fluvoxamine is excreted in breast milk in small amounts. For this reason, it should not be administered to nursing women.