metaPreg - Olanzapine during pregnancy

Olanzapine updated on 06-10-2025

Table Graphic exposition period:

Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Congenital malformations
All congenital malformations (majors, minors, majors and minors, or unspecified)	1.17 [0.98, 1.39]	0%	7 studies	30,858	3,534	not evaluable	ROB	-
Major congenital malformations	1.17 [0.98, 1.39]	0%	7 studies	30,858	3,534	not evaluable	ROB	-
Congenital heart defects	1.09 [0.78, 1.52]	0%	2 studies	137	2,442	not evaluable	ROB	-
Ano-rectal atresia and stenosis	2.44 [0.85, 6.96]	0%	2 studies	574	3,111	not evaluable	ROB	-
Microcephaly / Small head circumference for gestational age	0.77 [0.26, 2.28]	0%	2 studies	474	956	not evaluable	ROB	-
Limb defects	3.71 [1.36, 10.15]	-	1 study	242	413	not evaluable	ROB	6.88 [2.05; .]
Oro-facial clefts	2.56 [1.22, 5.38]	-	1 study		2,341	not evaluable	ROB	4.56 [1.74; .]
Bilateral renal agenesis including Potter syndrome	16.25 [1.01, 262.42]	-	1 study	75	770	not evaluable	ROB	31.99 [1.08; .]
Ebstein's anomaly	23.37 [1.44, 378.91]	-	1 study	52	770	not evaluable	ROB	46.23 [2.24; .]
Hypoplastic right heart (HRH/HRHS)	16.92 [1.05, 273.39]	-	1 study	72	770	not evaluable	ROB	33.34 [1.27; .]
26 non statistically significant endpoints reported in only one study
Growth parameters and prematurity
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Preterm (< 37 weeks)	1.28 [0.77, 2.11]	27%	4 studies	179	354	not evaluable	ROB	-
Small for gestational age (weight)	1.71 [1.07, 2.72]	0%	2 studies	64	353	not evaluable	ROB	2.80 [1.35; .]
Large head circumference for gestational age	3.02 [1.60, 5.71]	-	1 study		186	not evaluable	ROB	5.49 [2.58; .]
5 non statistically significant endpoints reported in only one study
Maternal consequences
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Gestational diabetes	1.53 [1.17, 2.00]	0%	5 studies	6,147	719	not evaluable	ROB	2.42 [1.61; .]
1 non statistically significant endpoints reported in only one study
Neonatal disorders
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Neonatal disorders (as a whole)	4.02 [2.07, 7.81]	-	1 study	56	86	not evaluable	ROB	7.51 [3.56; .]
3 non statistically significant endpoints reported in only one study
Intrauterine deaths
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions	1.00 [0.80, 1.25]	0%	3 studies	158,486	403	not evaluable	ROB	-
1 non statistically significant endpoints reported in only one study
Neuro-developmental disorders
Adverse outcome	OR 95%CI	I2	k	No. cases	No. exposed	publication bias	ROB	E-value
Cognitive developmental disorders/delay (> 6 years old)	0.80 [0.35, 1.85]	27%	2 studies	876	2,727	not evaluable	ROB	-
Language disorders/delay	0.92 [0.73, 1.16]	0%	2 studies	78,524	2,676	not evaluable	ROB	-
Learning disorders	0.70 [0.38, 1.29]	0%	2 studies	1,310	1,181	not evaluable	ROB	-
Neuro-developmental disorders (as a whole)	0.93 [0.80, 1.09]	0%	2 studies	160,370	2,895	not evaluable	ROB	-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)	0.80 [0.35, 1.85]	27%	2 studies	876	2,727	not evaluable	ROB	-
5 non statistically significant endpoints reported in only one study