Drug Levels and Effects:

Summary of Use during Lactation:

Limited information indicates that maternal quetiapine oral doses of up to 400 mg daily produce low levels in milk. Because there is little published experience with quetiapine during breastfeeding and little long-term follow-up data, other agents may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels:

Maternal Levels.

One mother took oral quetiapine 200 mg daily throughout pregnancy and postpartum. At 3 weeks postpartum, milk samples were taken. The average milk level over the 6-hour dosage interval was 13 mcg/L. A peak milk quetiapine level of 62 mcg/L occurred at 1 hour after the dose. The authors estimated that an exclusively breastfed infant would receive 0.09% of the weight-adjusted maternal dosage on average, with a "worst-case"dosage (assuming all nursing was at the peak concentration) of 0.43% of weight-adjusted maternal dosage.[1]

Six nursing mothers who were 6.5 to 18.5 weeks postpartum were taking quetiapine in doses of 25 to 400 mg daily in addition to an antidepressant for major depression postpartum. Milk samples obtained at various times after the dose had undetectable (<11.5 mcg/L) levels of quetiapine in the 4 mothers taking 75 mg daily or less. A mother taking 100 mg daily had a milk quetiapine level of 12.3 mcg/L and another taking 400 mg daily had a level of 101 mcg/L. The authors estimated that exclusively breastfed infants would receive less than 0.01 mg/kg daily with maternal doses of 100 mg daily or less and less than 0.1 mg/kg daily with a maternal dose of 400 mg daily.[2]

A woman who was 3 months postpartum and taking quetiapine 400 mg daily, fluoxetine 40 mg daily, and oxycodone 20 mg 3 times daily had 16 milk samples taken over 24 hours starting immediately before a daily dose of quetiapine; 12 were paired fore- and hindmilk and the other 4 samples were mixtures of fore- and hindmilk. The highest quetiapine level measured in milk of about 170 mcg/L occurred within 1 hour after the dose. Milk levels dropped to nearly zero by 12 hours after the dose. No differences were noted between fore- and hindmilk concentrations. The authors estimated that the infant received 6.2 mcg/kg daily and that a fully breastfed infant would receive 0.09% of the maternal weight-adjusted dosage.[3]

A nursing mother was taking quetiapine in a dosage of 200 mg daily. Quetiapine was undetectable (<5 mcg/L) in her breastmilk.[4]

In a study of 9 women taking quetiapine in an average dose of 37 mg daily (range 6.25 - 100 mg daily), simulations of infant exposure indicated that the infant would receive <0.5% of="" the="" maternal="" weight-adjusted="">

Infant Levels.

A 3-month-old infant who was breastfed 6 to 7 times daily during maternal use of 400 mg daily of quetiapine had a plasma quetiapine level of 1.4 mcg/L. This level was 6% of the mother's quetiapine plasma level at the same time.[3]

In a study of 9 women taking quetiapine in an average dose of 37 mg daily (range 6.25 - 100 mg daily), simulations of infant exposure indicated that the infant would be expected to attain serum concentrations <0.6% of="" the="" maternal="" serum="" quetiapine="">

Effects in Breastfed Infants:

One mother took quetiapine 25 mg daily orally during pregnancy and continued to take quetiapine 50 mg daily orally during lactation. At 6 weeks the infant was doing well. No further follow-up was reported.[6]

Another infant whose mother was taking 200 mg daily of quetiapine began to exclusively breastfeed at 8 weeks of age. The infant was developing well at 4.5 months of age and no adverse effects were reported.[1]

A nursing mother with postpartum psychosis was started on quetiapine at 6 weeks postpartum at a dose of 25 mg daily along with unspecified benzodiazepines. The quetiapine dosage was increased gradually to 200 mg daily over the next 6 weeks and up to 300 mg daily over the ensuing 4 weeks (16 weeks postpartum). She was also started on mirtazapine 15 mg daily at 8 weeks postpartum. Breastfeeding (extent not specified) was continued until 16 weeks postpartum when it was stopped because of reduced milk production. During this time the infant was excessively drowsy until the benzodiazepine dosage was deceased at the same time as the quetiapine dosage was increased. The infant was followed for at least 2 months after breastfeeding ended and no effects on the infant's growth, motor or psychological development or signs of infant withdrawal were noted.[7]

A nursing mother with bipolar disorder began taking 20 mg of paroxetine at 4 months postpartum and was then started on quetiapine 200 mg twice daily at 6 months postpartum. She breastfed regularly (extent not stated) and no obvious adverse effects were noted in the infant.[8]

A woman who was treated chronically with quetiapine 400 mg and fluvoxamine 200 mg daily took the drugs throughout pregnancy and postpartum. She partially breastfed her infant (extent not stated) for 3 months from birth. No adverse events were seen and the infant developed normally.[9]

Six nursing mothers took quetiapine in doses of 25 to 400 mg daily in addition to an antidepressant (usually paroxetine) for major depression postpartum. Their breastfed infants' development were tested at 9 to 18 months of age with the Bayley scales. Measurements were slightly low on the mental and psychomotor development scale in one infant and on the mental development scale in another. All other scores were within normal limits. The authors concluded that the low scores of the 2 infants were probably not caused by the drugs received by the infants in breastmilk.[2]

An infant was born to a mother taking quetiapine 400 mg daily as well as fluoxetine 40 mg daily and oxycodone 20 mg 3 times daily. The infant was breastfed 6 to 7 times daily and was receiving 120 mcg of oral morphine 3 times daily for opiate withdrawal. Upon examination at 3 months of age, the infant's weight was at the 25th percentile for age, having been at the 50th percentile at birth. The infant's Denver developmental score was equal to his chronological age.[3]

One 60-week-old infant who was 50% breastfed was breastfed during maternal therapy with quetiapine 75 mg daily mg daily and venlafaxine 225 mg daily. No adverse reactions were reported by the mother or in the medical records.[10]

Possible Effects on Lactation:

Unlike the phenothiazines, quetiapine has a minimal effect on serum prolactin levels.[11][12][13]

Galactorrhea occurred in a woman who was not breastfeeding while she was taking venlafaxine 112.5 mg daily and quetiapine. Galactorrhea occurred 10 days after her quetiapine dose was increased to 50 mg daily a few days after starting the drug at 12.5 mg daily. Her serum prolactin level was 27.3 mcg/L (normal 2 to 30 mcg/L) and decreased to 8.5 mcg/L 2 weeks after discontinuing the drug. Galactorrhea ceased 1 week later.[14]

The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternate Drugs to Consider:



1. Lee A, Giesbrecht E, Dunn E et al. Excretion of quetiapine in breast milk. Am J Psychiatry. 2004;161:1715-6. PMID:15337669
2. Misri S, Corral M, Wardrop AA, Kendrick K. Quetiapine augmentation in lactation: a series of case reports. J Clin Psychopharmacol. 2006;26:508-11. PMID:16974194
3. Rampono J, Kristensen JH, Ilett KF et al. Quetiapine and breast feeding. Ann Pharmacother. 2007;41:711-4. PMID:17374621
4. Kruninger U, Meltzer V, Hiemke C et al. [Pregnancy and lactation under treatment with quetiapin]. Psychiatr Prax Suppl. 2007;34:S75-6.
5. Yazdani-Brojeni P, Taguchi N, Garcia-Bournissen F et al. Quetiapine in human milk and simulation-based assessment of infant exposure. Clin Pharmacol Ther. 2010;87 (Suppl. 1):S3-4. Abstract.
6. Balke LD. Quetiapine effective in the treatment of bipolar affective disorder during pregnancy. World J Biol Psychiatry. 2001;2:303S. Abstract P021-15.
7. Seppala J. Quetiapine ('Seroquel') is effective and well tolerated in the treatment of psychotic depression during breast-feeding. Int J Neuropsychopharmacol. 2004;7 (Suppl 1):S245. Abstract P01.431.
8. Ritz S. Quetiapine monotherapy in post-partum onset bipolar disorder with a mixed affective state. Eur Neuropsychopharmacol. 2005;15 (Suppl 3):S407. Abstract.
9. Gentile S. Quetiapine-fluvoxamine combination during pregnancy and while breastfeeding. Arch Womens Ment Health. 2006. PMID:16633783
10. Newport DJ, Ritchie JC, Knight BT et al. Venlafaxine in human breast milk and nursing infant plasma: determination of exposure. J Clin Psychiatry. 2009;70:1304-10. PMID:19607765
11. Atmaca M, Kuloglu M, Tezcan E et al. Quetiapine is not associated with increase in prolactin secretion in contrast to haloperidol. Arch Med Res. 2002;33(6):562-5. PMID:12505103
12. Maguire GA. Prolactin elevation with antipsychotic medications: mechanisms of action and clinical consequences. J Clin Psychiatry. 2002;63 (Suppl 4):56-62. PMID:11913677
13. Arvanitis LA , Miller BG. Multiple fixed doses of "Seroquel" (quetiapine) in patients with acute exacerbation of schizophrenia: a comparison with haloperidol and placebo. The seroquel trial 13 study group. Biol Psychiatry. 1997;42:233-46. PMID:9270900
14. Pae CU, Kim JJ, Lee CU et al. Very low dose quetiapine-induced galactorrhea in combination with venlafaxine. Hum Psychopharmacol. 2004;19:433-4. PMID:15303249

Substance Identification:

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CAS Registry Number:


Drug Class:

  • Antipsychotic Agents

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