Primidone AND Phenobarbital (All indications) updated on 04-22-2025

Table   Graphic     exposition period:

Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
All congenital malformations (majors, minors, majors and minors, or unspecified)2.33 [1.71, 3.18]8%17 studies49,9111,361low ROB4.09 [2.81; .]
Major congenital malformations2.36 [1.71, 3.25]3%13 studies49,8541,171low ROB4.15 [2.81; .]
Microcephaly / Small head circumference for gestational age2.24 [1.35, 3.71]0%7 studies134,517511serious ROB3.90 [2.03; .]
Congenital heart defects3.07 [1.18, 8.01]48%6 studies53652not evaluable ROB5.60 [1.64; .]
Hypospadias2.15 [0.63, 7.31]0%6 studies3,382595not evaluable ROB-
Minor congenital malformations1.93 [0.91, 4.11]8%4 studies66206not evaluable ROB-
Spina bifida6.95 [0.78, 61.60]37%3 studies620119not evaluable ROB-
Club foot / Talipes equinovarus3.70 [0.51, 26.97]0%3 studies1,67899not evaluable ROB-
Oro-facial clefts4.46 [1.70, 11.72]0%4 studies2,831600not evaluable ROB8.40 [2.79; .]
Ano-rectal atresia and stenosis4.00 [0.12, 134.90]63%2 studies54592not evaluable ROB-
Cleft lip with or without cleft palate6.65 [0.81, 54.48]0%2 studies1,638137not evaluable ROB-
Craniosynostosis8.30 [0.83, 83.23]0%2 studies76684not evaluable ROB-
Hip dislocation and/or dysplasia4.08 [0.31, 53.22]0%2 studies116not evaluable ROB-
Neural Tube Defects2.60 [0.40, 17.05]26%4 studies6617not evaluable ROB-
Polydactyly4.00 [0.24, 66.68]49%3 studies4304not evaluable ROB-
Urinary malformations0.59 [0.11, 3.19]0%2 studies15431not evaluable ROB-
Atrioventricular septal defect22.27 [1.38, 359.70]-1 study52980not evaluable ROB44.04 [2.10; .]
Bilateral renal agenesis including Potter syndrome156.25 [9.60, 2543.08]-1 study7580not evaluable ROB311.99 [18.69; .]
Bladder exstrophy and/or epispadia142.99 [8.79, 2325.49]-1 study8280not evaluable ROB285.48 [17.07; .]
Diaphragmatic hernia31.16 [1.93, 503.50]-1 study37880not evaluable ROB61.82 [3.27; .]
Ebstein's anomaly233.60 [14.29, 3819.26]-1 study5080not evaluable ROB466.70 [28.07; .]
Gastroschisis48.44 [3.00, 783.49]-1 study24380not evaluable ROB96.38 [5.44; .]
Hypoplastic left heart (HLH/HLHS)54.48 [3.37, 881.52]-1 study21680not evaluable ROB108.46 [6.19; .]
Hypoplastic right heart (HRH/HRHS)177.39 [10.89, 2890.83]-1 study6680not evaluable ROB354.29 [21.26; .]
Oesophageal atresia with or without tracheo-oesophageal fistula30.05 [1.86, 485.50]-1 study39280not evaluable ROB59.60 [3.12; .]
Omphalocele44.26 [2.74, 715.69]-1 study26680not evaluable ROB88.02 [4.92; .]
Pulmonary valve atresia77.35 [4.77, 1253.19]-1 study15280not evaluable ROB154.20 [9.02; .]
Tetralogy of Fallot20.18 [1.25, 325.80]-1 study58480not evaluable ROB39.85 [1.81; .]
Ventricular septal defect10.50 [1.91, 57.73]-1 study4,64580not evaluable ROB20.49 [3.23; .]
9 non statistically significant endpoints reported in only one study

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.27 [0.62, 2.59]48%6 studies91,665310not evaluable ROB-
Small for gestational age (weight)2.03 [1.31, 3.14]50%5 studies613,691457not evaluable ROB3.47 [1.94; .]
Low birth weight (< 2500g)1.72 [0.93, 3.20]57%3 studies232,923337not evaluable ROB-
Macrosomia (> 4000g)0.49 [0.29, 0.82]0%2 studies577,11494not evaluable ROB3.54 [.; 1.72]
3 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
3 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Feeding difficulty4.51 [0.63, 32.30]0%3 studies316not evaluable ROB-
Neonatal disorders (as a whole)0.77 [0.39, 1.52]0%2 studies222,21288not evaluable ROB-
Neonatal intracranial hemorrhage1.03 [0.66, 1.61]0%3 studies100231not evaluable ROB-
Low Apgar score (< 7) (at 1 min)0.55 [0.02, 15.67]36%2 studies222not evaluable ROB-
9 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)1.87 [0.51, 6.88]0%3 studies4,703395not evaluable ROB-
Child/Infant head circumference abnormalities (> 1 year)--0 study-
Child/Infant lenght abnormalities (> 1 year)--0 study-
Child/Infant weight abnormalities (> 1 year)--0 study-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)0.92 [0.41, 2.07]28%3 studies182401not evaluable ROB-
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.06 [0.63, 1.79]1%2 studies165263not evaluable ROB-
Perinatal death0.59 [0.05, 6.30]0%2 studies3356not evaluable ROB-
3 non statistically significant endpoints reported in only one study

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neuro-developmental disorders (as a whole)2.00 [1.14, 3.52]0%5 studies10,481328serious ROB3.42 [1.54; .]
Language disorders/delay2.51 [1.33, 4.74]23%4 studies72,019133not evaluable ROB4.46 [2.00; .]
ASD (Autism spectrum disorder): Diagnosis2.36 [1.00, 5.54]0%2 studies4,552259not evaluable ROB4.15 [1.06; .]
ASD (Autism spectrum disorder): Diagnosis/Risk2.36 [1.00, 5.54]0%2 studies4,552259not evaluable ROB4.15 [1.06; .]
Cognitive developmental disorders/delay (3-6 years old)7.18 [1.16, 44.46]34%2 studies3,39987not evaluable ROB13.84 [1.59; .]
Cognitive developmental disorders/delay (> 6 years old)2.70 [1.28, 5.68]0%3 studies158not evaluable ROB4.84 [1.88; .]
Cognitive developmental disorders/delay (< 3 years old)1.06 [0.14, 8.09]53%2 studies396not evaluable ROB-
Psychomotor developmental disorders/delay1.34 [0.82, 2.21]0%2 studies698not evaluable ROB-
Learning disorders 3.12 [0.30, 32.23]78%2 studies761not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (< 3 years old)--0 study-
2 non statistically significant endpoints reported in only one study

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