Phenobarbital (All indications)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Lowe (Phenobarbital) (Controls unexposed, sick), 1973 Robert (Phenobarbital), 1986 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Kaneko (Phenobarbital), 1999 Samrén (Phenobarbital), 1999 Canger (Phenobarbital), 1999 Dean (Phenobarbital), 2002 Kaaja (Phenobarbital), 2003 Endo (Phenobarbital) (Controls unexposed, sick), 2004 Bànhidy (Phenobarbital), 2011 Cassina (Phenobarbital) (Controls unexposed, disease free) (Other indications), 2013 Källén (Phenobarbital) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Tomson (Phenobarbital), 2018 Vajda (Phenobarbital) (Controls unexposed, sick), 2019 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 172.48[1.83; 3.35]49,8921,200low Major congenital malformations Robert (Phenobarbital), 1986 Canger (Phenobarbital), 1999 Samrén (Phenobarbital), 1999 Dean (Phenobarbital), 2002 Kaaja (Phenobarbital), 2003 Bànhidy (Phenobarbital), 2011 Källén (Phenobarbital) (Controls unexposed, NOS) (Indications NOS), 2013 Cassina (Phenobarbital) (Controls unexposed, disease free) (Other indications), 2013 Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Tomson (Phenobarbital), 2018 Vajda (Phenobarbital) (Controls unexposed, sick), 2019 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 132.56[1.85; 3.54]49,8411,049low Congenital heart defects Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital), 2018 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 53.93[1.79; 8.63]48646not evaluable Hypospadias Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital), 2018 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 53.03[0.81; 11.39]3,379589not evaluable Microcephaly / Small head circumference for gestational age Kelly (Phenobarbital), 1984 Dravet (Phenobarbital), 1992 Battino (Phenobarbital), 1999 Díaz-Romero (Phenobarbital), 1999 Holmes (Phenobarbital) (Controls unexposed, sick), 2001 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 63.09[1.34; 7.13]476294not evaluable Minor congenital malformations Robert (Phenobarbital), 1986 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Battino (Phenobarbital), 1992 Dean (Phenobarbital), 2002 41.92[0.88; 4.18]59173not evaluable Spina bifida Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 36.95[0.78; 61.60]620119not evaluable Oro-facial clefts Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Tomson (Phenobarbital), 2018 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 44.46[1.70; 11.72]2,831600not evaluable Ano-rectal atresia and stenosis Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 24.00[0.12; 134.90]54592not evaluable Cleft lip with or without cleft palate Lowe (Phenobarbital) (Controls unexposed, sick), 1973 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 26.86[0.84; 56.26]1,638133not evaluable Club foot / Talipes equinovarus Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 24.55[0.47; 44.55]1,67792not evaluable Craniosynostosis D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 28.30[0.83; 83.23]76684not evaluable Hip dislocation and/or dysplasia D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 24.08[0.31; 53.22]116not evaluable Neural Tube Defects Canger (Phenobarbital), 1999 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital), 2018 32.92[0.29; 29.59]5576not evaluable Polydactyly D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Tomson (Phenobarbital), 2018 213.45[0.76; 236.46]2298not evaluable Urinary malformations Tomson (Phenobarbital), 2018 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 20.59[0.11; 3.19]15431not evaluable Atrial septal defect Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 13.60[0.22; 58.12]3,26880not evaluable Atrioventricular septal defect Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 122.27[1.38; 359.70]52980not evaluable Bilateral renal agenesis including Potter syndrome Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 1Out of scale156.25[9.60; 2543.08]7580not evaluable Bladder exstrophy and/or epispadia Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 1Out of scale142.99[8.79; 2325.49]8280not evaluable Cleft palate Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 110.00[0.62; 161.44]1,17880not evaluable Coarctation of aorta Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 115.13[0.94; 244.20]77980not evaluable Congenital cataract Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 10.59[0.02; 15.81]112not evaluable Diaphragmatic hernia Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 131.16[1.93; 503.50]37880not evaluable Digestive system anomalies Thomas (Phenobarbital) (Controls unexposed, sick), 2021 10.83[0.03; 20.42]1137not evaluable Down syndrom / Trisomy 21 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 12.14[0.03; 131.94]-4not evaluable Ebstein's anomaly Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 1Out of scale233.60[14.29; 3819.26]5080not evaluable Gastroschisis Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 148.44[3.00; 783.49]24380not evaluable Hypoplastic left heart (HLH/HLHS) Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 154.48[3.37; 881.52]21680not evaluable Hypoplastic right heart (HRH/HRHS) Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 1Out of scale177.39[10.89; 2890.83]6680not evaluable Limb defects Thomas (Phenobarbital) (Controls unexposed, sick), 2021 12.50[0.35; 17.96]4137not evaluable Nervous system anomalies Thomas (Phenobarbital) (Controls unexposed, sick), 2021 17.52[0.30; 185.67]1137not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 130.05[1.86; 485.50]39280not evaluable Omphalocele Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 144.26[2.74; 715.69]26680not evaluable Pulmonary valve atresia Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 177.35[4.77; 1253.19]15280not evaluable Tetralogy of Fallot Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 120.18[1.25; 325.80]58480not evaluable Ventricular septal defect Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 110.50[1.91; 57.73]4,64580not evaluable Eye defects Dean (Phenobarbital), 2002 10.92[0.30; 2.84]1561not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Koch (Phenobarbital), 1996 Endo (Phenobarbital) (Controls unexposed, sick), 2004 Kilic (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 51.34[0.80; 2.23]91,658206not evaluable Small for gestational age (weight) Endo (Phenobarbital) (Controls unexposed, sick), 2004 Burja (Phenobarbital) (Controls unexposed, sick), 2006 Kilic (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Hernández-Díaz (Phenobarbital), 2017 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 52.20[1.66; 2.91]168,006369not evaluable Low birth weight (< 2500g) Kilic (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 22.54[1.60; 4.02]91,725180not evaluable Macrosomia (> 4000g) Endo (Phenobarbital) (Controls unexposed, sick), 2004 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 20.49[0.29; 0.82]577,11494not evaluable Extremely preterm (< 28 weeks) Coste (Phenobarbital) (Controls unexposed, NOS), 2020 15.01[0.31; 80.81]2,04184not evaluable Very preterm (28 to 32 weeks) Coste (Phenobarbital) (Controls unexposed, NOS), 2020 12.39[0.33; 17.16]8,58584not evaluable Large head circumference for gestational age Díaz-Romero (Phenobarbital), 1999 15.00[0.07; 366.35]-2not evaluable Maternal consequences Assisted deliveries (forceps, vacuum, ...) Endo (Phenobarbital) (Controls unexposed, sick), 2004 10.05[0.00; 6.68]-10not evaluable Caesarean Endo (Phenobarbital) (Controls unexposed, sick), 2004 10.18[0.00; 12.84]110not evaluable Polyhydramnios Endo (Phenobarbital) (Controls unexposed, sick), 2004 10.05[0.00; 6.68]-10not evaluable Neonatal disorders Feeding difficulty D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Yerby (Phenobarbital), 1992 Burja (Phenobarbital) (Controls unexposed, sick), 2006 35.62[0.72; 44.00]315not evaluable Neonatal disorders (as a whole) D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 20.77[0.39; 1.52]222,21288not evaluable Neonatal intracranial hemorrhage D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Shankaran (Phenobarbital) (Other indications), 2002 Burja (Phenobarbital) (Controls unexposed, sick), 2006 31.04[0.66; 1.62]100230not evaluable Low Apgar score (< 7) (at 1 min) Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Endo (Phenobarbital) (Controls unexposed, sick), 2004 20.55[0.02; 15.67]222not evaluable Cerebral palsy Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 11.87[0.03; 100.54]-12not evaluable Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation Burja (Phenobarbital) (Controls unexposed, sick), 2006 163.00[0.51; 7760.63]-1not evaluable Jaundice D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 10.62[0.02; 19.59]14not evaluable Neonatal hypotonia D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 12.14[0.03; 131.94]-4not evaluable Neonatal infections D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 12.14[0.03; 131.94]-4not evaluable Neonatal medical care D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 12.14[0.03; 131.94]-4not evaluable Neonatal tachypnea D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 12.14[0.03; 131.94]-4not evaluable Eye deficiency / Visual abnormality Shankaran (Phenobarbital) (Other indications), 2002 12.66[0.27; 25.79]4224not evaluable Hearing loss / Auditory deficit Shankaran (Phenobarbital) (Other indications), 2002 10.88[0.30; 2.54]14224not evaluable Long term consequences Child/Infant death (> 28 days of life) Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Shankaran (Phenobarbital) (Other indications), 2002 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 31.87[0.51; 6.88]4,703395not evaluable Child/Infant head circumference abnormalities (> 1 year) 0----- Child/Infant lenght abnormalities (> 1 year) 0----- Child/Infant weight abnormalities (> 1 year) 0----- Intrauterine deaths Intrauterine deaths (as a whole or unspecified) Tomson (Phenobarbital), 2015 Miškov (Phenobarbital) (Controls unexposed, sick), 2016 Trivedi (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2018 30.92[0.41; 2.07]182401not evaluable Early intrauterine death (< 22 weeks) Tomson (Phenobarbital), 2015 Miškov (Phenobarbital) (Controls unexposed, sick), 2016 21.06[0.63; 1.79]165263not evaluable Elective/induced termination of pregnancy Miškov (Phenobarbital) (Controls unexposed, sick), 2016 11.40[0.02; 97.44]-3not evaluable Therapeutic terminations of pregnancy Miškov (Phenobarbital) (Controls unexposed, sick), 2016 11.40[0.02; 97.44]-3not evaluable Perinatal death Canger (Phenobarbital), 1999 Tomson (Phenobarbital), 2015 20.67[0.06; 7.16]3321not evaluable Late intrauterine deaths (> 22 weeks) Tomson (Phenobarbital), 2015 12.46[0.49; 12.25]8260not evaluable Neuro-developmental disorders Neuro-developmental disorders (as a whole) Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Katz (Phenobarbital), 2001 Dean (Phenobarbital) (Controls unexposed, sick), 2007 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Bjørk (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2022 52.01[1.15; 3.54]10,481326not evaluable Language disorders/delay Kasradze (Phenobarbital) (Controls unexposed, disease free), 2017 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Adams (Phenobarbital), 2022 Thomas (Phenobarbitone), 2022 42.51[1.33; 4.74]72,019133not evaluable ASD (Autism spectrum disorder): Diagnosis Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Bjørk (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2022 22.36[1.00; 5.54]4,552259not evaluable ASD (Autism spectrum disorder): Diagnosis/Risk Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Bjørk (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2022 22.36[1.00; 5.54]4,552259not evaluable Cognitive developmental disorders/delay (3-6 years old) Kasradze (Phenobarbital) (Controls unexposed, disease free), 2017 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 27.18[1.16; 44.46]3,39987not evaluable Cognitive developmental disorders/delay (> 6 years old) Titze (Phenobarbital) (Controls unexposed, sick), 2008 Adams (Phenobarbital), 2022 Thomas (Phenobarbitone), 2022 32.93[1.39; 6.17]149not evaluable Cognitive developmental disorders/delay (< 3 years old) Kelly (Phenobarbital), 1984 Thomas b (Phenobarbital), 2008 20.70[0.27; 1.84]2454not evaluable Learning disorders Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Elkjaer (Phenobarbital), 2018 23.12[0.30; 32.23]761not evaluable Psychomotor developmental disorders/delay Koch (Phenobarbital), 1996 Thomas b (Phenobarbital), 2008 20.56[0.20; 1.61]2045not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Coste (Phenobarbital) (Controls unexposed, NOS), 2020 13.00[0.41; 21.94]3,39984not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Titze (Phenobarbital) (Controls unexposed, sick), 2008 11.53[0.05; 49.80]13not evaluable Severe cognitive developmental delay (Mental retardation) (< 3 years old) 0-----0.0100.01.0

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