Phenytoin (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)2.03 [1.45, 2.83]21%21 studies49,8811,602probable ROB3.47 [2.26; .]
Major congenital malformations1.65 [1.18, 2.32]9%15 studies49,7721,357low ROB2.70 [1.64; .]
Congenital heart defects2.10 [0.93, 4.72]41%9 studies65875not evaluable ROB-
Limb defects2.20 [0.64, 7.52]0%5 studies14290not evaluable ROB-
Neural Tube Defects3.20 [0.89, 11.45]0%6 studies8694not evaluable ROB-
Microcephaly / Small head circumference for gestational age0.72 [0.32, 1.63]0%6 studies26330not evaluable ROB-
Cleft lip with or without cleft palate5.07 [0.94, 27.30]0%5 studies3113not evaluable ROB-
Hypospadias0.75 [0.22, 2.57]0%5 studies18666serious ROB-
Polydactyly2.60 [0.22, 30.36]45%4 studies3168not evaluable ROB-
Minor congenital malformations2.46 [1.09, 5.57]26%4 studies71106not evaluable ROB4.36 [1.40; .]
Spina bifida3.70 [0.29, 47.79]46%4 studies2101not evaluable ROB-
Urinary malformations1.17 [0.16, 8.76]27%3 studies15282not evaluable ROB-
Digestive system anomalies1.88 [0.29, 12.03]0%2 studies5201not evaluable ROB-
Oro-facial clefts1.91 [0.55, 6.62]0%3 studies14623not evaluable ROB-
Cleft palate4.13 [0.07, 229.95]48%2 studies122not evaluable ROB-
Craniosynostosis1.92 [0.08, 44.92]-1 study222not evaluable ROB-
Down syndrom / Trisomy 211.10 [0.04, 30.00]-1 study122not evaluable ROB-
Eye defects1.75 [0.31, 9.77]24%2 studies1162not evaluable ROB-
Hip dislocation and/or dysplasia1.10 [0.04, 30.00]-1 study122not evaluable ROB-
Nervous system anomalies8.67 [0.35, 214.26]-1 study1119not evaluable ROB-
Chromosomal abnormalities25.03 [0.49, 1278.58]-1 study38not evaluable ROB-
Club foot / Talipes equinovarus0.57 [0.01, 30.76]-1 study120not evaluable ROB-
Ear, face and neck anomalies4.99 [0.24, 105.88]-1 study238not evaluable ROB-
Genital anomalies2.26 [0.12, 41.69]-1 study538not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)2.14 [0.99, 4.62]0%7 studies491108not evaluable ROB-
Small for gestational age (weight)0.85 [0.43, 1.69]0%5 studies446,283162not evaluable ROB-
Large for gestational age (weight)3.81 [0.42, 34.93]25%2 studies7427not evaluable ROB-
Low birth weight (< 2500g)1.94 [0.83, 4.52]-1 study141,44881not evaluable ROB-
Large head circumference for gestational age0.37 [0.01, 20.14]-1 study21not evaluable ROB-

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean0.19 [0.03, 1.30]-1 study33226not evaluable ROB-
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)43.00 [0.35, 5328.22]-1 study1not evaluable ROB-
Gestational diabetes13.67 [0.19, 964.02]-1 study11not evaluable ROB-
Preeclampsia43.00 [0.35, 5328.22]-1 study1not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Neonatal medical care1.25 [0.29, 5.38]0%5 studies1,98449not evaluable ROB-
Low Apgar score (< 7) (at 1 min)3.53 [1.15, 10.87]4%3 studies8577not evaluable ROB6.52 [1.55; .]
Low Apgar score (< 7) (at 5 min)20.01 [2.75, 145.51]0%3 studies558not evaluable ROB39.51 [4.95; .]
Feeding difficulty1.79 [0.18, 18.25]0%2 studies234not evaluable ROB-
Jaundice / Icterus0.70 [0.05, 8.97]-1 study322not evaluable ROB-
Neonatal disorders (as a whole)3.00 [0.49, 18.25]-1 study1322not evaluable ROB-
Neonatal hypotonia1.92 [0.08, 44.92]-1 study222not evaluable ROB-
Neonatal infections1.10 [0.04, 30.00]-1 study122not evaluable ROB-
Neonatal intracranial hemorrhage1.10 [0.04, 30.00]-1 study122not evaluable ROB-
Neonatal tachypnea0.35 [0.01, 19.18]-1 study22not evaluable ROB-
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation--0 study-

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)6.37 [0.34, 118.32]-1 study526not evaluable ROB-
Child/Infant growth abnormalities (> 1 year)0.74 [0.17, 3.12]-1 study945not evaluable ROB-
Child/Infant head circumference abnormalities (> 1 year)4.48 [0.18, 112.88]-1 study140not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)5.01 [1.66, 15.13]0%5 studies19218not evaluable ROB9.49 [2.70; .]
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.73 [0.12, 25.30]0%2 studies26not evaluable ROB-
Perinatal death2.05 [0.20, 20.82]0%2 studies1057not evaluable ROB-
Elective/induced termination of pregnancy7.00 [0.05, 953.26]-1 study1not evaluable ROB-
Late intrauterine deaths (> 22 weeks) / Stillbirths12.49 [0.56, 277.13]0%2 studies6not evaluable ROB-
Therapeutic terminations of pregnancy7.00 [0.05, 953.26]-1 study1not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Cognitive developmental disorders/delay (> 6 years old)1.08 [0.56, 2.07]34%7 studies1,124363not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis1.37 [0.45, 4.18]33%3 studies68,799249not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis/Risk1.37 [0.45, 4.18]33%3 studies68,799249not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.13 [0.77, 1.64]0%3 studies147,639257not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.13 [0.77, 1.64]0%3 studies147,639257not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)0.86 [0.33, 2.25]0%4 studies1,120292not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)1.36 [0.56, 3.32]66%4 studies31185not evaluable ROB-
Language disorders/delay0.99 [0.61, 1.63]0%4 studies6111not evaluable ROB-
Neuro-developmental disorders (as a whole)2.37 [0.65, 8.62]47%4 studies5157not evaluable ROB-
Psychomotor developmental disorders/delay0.90 [0.59, 1.38]0%3 studies5123not evaluable ROB-
Learning disorders 0.88 [0.53, 1.47]-1 study76288not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Risk0.53 [0.10, 2.73]-1 study931not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)1.15 [0.30, 4.31]-1 study1043not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (< 3 years old)1.40 [0.40, 4.90]-1 study1142not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)1.71 [0.03, 87.56]-1 study43not evaluable ROB-

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