Phenytoin (All indications) updated on 12-01-2025

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 [1.46, 2.84]21%21 studies49,8811,602probable ROB3.49 [2.27; .]
Major congenital malformations1.66 [1.18, 2.33]10%15 studies49,7721,357low ROB2.71 [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-
Eye defects1.75 [0.31, 9.77]24%2 studies1162not evaluable ROB-
8 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)1.34 [0.69, 2.59]27%8 studies726531serious ROB-
Small for gestational age (weight)0.61 [0.42, 0.90]0%6 studies446,429585not evaluable ROB2.65 [.; 1.46]
Large for gestational age (weight)3.81 [0.42, 34.93]25%2 studies7427not evaluable ROB-
2 non statistically significant endpoints reported in only one study

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

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-
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation--0 study-
6 non statistically significant endpoints reported in only one study

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

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-
Late intrauterine deaths (> 22 weeks) / Stillbirths12.49 [0.56, 277.13]0%2 studies6not evaluable ROB-
2 non statistically significant endpoints reported in only one study

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-
5 non statistically significant endpoints reported in only one study

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