Pregabalin (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)1.78 [0.81, 3.93]51%7 studies87,899701not evaluable ROB-
Major congenital malformations1.78 [0.81, 3.93]51%7 studies87,899701not evaluable ROB-
Microcephaly / Small head circumference for gestational age1.00 [0.80, 1.25]0%3 studies134,5444,372not evaluable ROB-
Oro-facial clefts1.89 [0.35, 10.09]29%2 studies2,8191,701not evaluable ROB-
Spina bifida4.33 [0.49, 38.62]37%2 studies6201,701not evaluable ROB-
Coarctation of aorta5.80 [1.90, 17.70]-1 study7831,671not evaluable ROB11.08 [3.21; .]
Congenital heart defects--0 study-
Craniosynostosis4.40 [1.16, 16.72]-1 study7691,671not evaluable ROB8.27 [1.59; .]
Digestive system anomalies--0 study-
Eye defects--0 study-
Genital anomalies--0 study-
Limb defects--0 study-
Nervous system anomalies--0 study-
Urinary malformations--0 study-
Respiratory system anomalies--0 study-
19 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)1.60 [1.08, 2.38]42%4 studies91,7612,159not evaluable ROB2.58 [1.37; .]
Low birth weight (< 2500g)1.35 [1.08, 1.69]52%3 studies233,1623,868not evaluable ROB2.04 [1.37; .]
Small for gestational age (weight)1.15 [1.05, 1.27]0%3 studies614,1384,339not evaluable ROB1.57 [1.26; .]
3 non statistically significant endpoints reported in only one study

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

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low Apgar score (< 7) (at 5 min)--0 study-
1 non statistically significant endpoints reported in only one study

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

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Late intrauterine deaths (> 22 weeks) / Stillbirths--0 study-
1 non statistically significant endpoints reported in only one study

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ASD (Autism spectrum disorder): Diagnosis0.78 [0.62, 0.99]5%4 studies81,0695,008not evaluable ROB1.89 [.; 1.14]
ASD (Autism spectrum disorder): Diagnosis/Risk0.78 [0.62, 0.99]5%4 studies81,0695,008not evaluable ROB1.89 [.; 1.14]
ADHD (Attention deficit hyperactivity disorder): Diagnosis0.68 [0.55, 0.83]0%2 studies147,6961,715not evaluable ROB2.32 [.; 1.70]
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk0.68 [0.55, 0.83]0%2 studies147,6961,715not evaluable ROB2.32 [.; 1.70]
Cognitive developmental disorders/delay (3-6 years old)0.87 [0.31, 2.44]59%3 studies4,6683,701not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)0.87 [0.31, 2.44]59%3 studies4,6683,701not evaluable ROB-
Neuro-developmental disorders (as a whole)0.95 [0.54, 1.68]67%2 studies10,4943,293not evaluable ROB-
3 non statistically significant endpoints reported in only one study

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