Pregabalin (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)1.73 [0.80, 3.76]49%7 studies87,899712not evaluable ROB-
Major congenital malformations1.73 [0.80, 3.76]49%7 studies87,899712not 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)1.45 [1.08, 1.94]27%5 studies91,9602,221not evaluable ROB2.25 [1.38; .]
Small for gestational age (weight)1.15 [1.04, 1.26]0%4 studies614,2674,401not evaluable ROB1.56 [1.25; .]
Low birth weight (< 2500g)1.35 [1.08, 1.69]52%3 studies233,1623,868not evaluable ROB2.04 [1.37; .]
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
Intrauterine deaths (as a whole or unspecified)1.44 [1.31, 1.59]-1 study6,3882,337not evaluable ROB2.24 [1.94; .]
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-
Neuro-developmental disorders (as a whole)1.09 [0.75, 1.60]71%3 studies11,8934,088not 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-
3 non statistically significant endpoints reported in only one study

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