Tramadol (versus unexposed)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Gouraud, 2010 Källén, 2015 Sørensen, 2022 Bowie, 2022 Ferrer, 2025 51.26[1.04; 1.52]95,7197,467not evaluable Major congenital malformations Gouraud, 2010 Källén, 2015 Sørensen, 2022 Bowie, 2022 Ferrer, 2025 51.29[1.04; 1.60]66,0597,467not evaluable Congenital heart defects Källén, 2015 Bowie, 2022 Sørensen, 2022 Ferrer, 2025 41.22[0.98; 1.52]21,2357,352not evaluable Digestive system anomalies Bowie, 2022 Sørensen, 2022 Ferrer, 2025 31.46[0.63; 3.39]2,6255,576not evaluable Oro-facial clefts Bowie, 2022 Sørensen, 2022 Ferrer, 2025 31.00[0.51; 1.98]8035,576not evaluable Urinary malformations Bowie, 2022 Sørensen, 2022 Ferrer, 2025 31.76[1.20; 2.58]2,1985,576not evaluable Eye defects Sørensen, 2022 Ferrer, 2025 20.86[0.31; 2.42]1254,795not evaluable Genital anomalies Sørensen, 2022 Ferrer, 2025 20.88[0.46; 1.69]4224,795not evaluable Limb defects Sørensen, 2022 Ferrer, 2025 20.91[0.61; 1.35]6164,795not evaluable Nervous system anomalies Sørensen, 2022 Ferrer, 2025 21.94[1.15; 3.29]4064,795not evaluable Other anomalies/syndromes (non chromosomal) Sørensen, 2022 Ferrer, 2025 20.78[0.40; 1.50]5284,795not evaluable Abdominal wall defects Ferrer, 2025 12.69[0.37; 19.41]58999not evaluable Atrial septal defect Bowie, 2022 12.28[0.99; 5.25]1,970781not evaluable Cardiac septal defects Källén, 2015 11.78[1.06; 3.00]8,9071,776not evaluable Club foot / Talipes equinovarus Källén, 2015 13.63[1.78; 7.40]2,2841,776not evaluable Ear, face and neck anomalies Ferrer, 2025 13.19[0.44; 23.13]49999not evaluable Genetic syndromes and microdeletions Ferrer, 2025 11.02[0.33; 3.19]451999not evaluable Hypospadias Källén, 2015 10.95[0.36; 2.54]5,0811,776not evaluable Minor congenital malformations Bowie, 2022 11.60[0.78; 3.28]3,774781not evaluable Polydactyly Källén, 2015 11.77[0.59; 5.32]1,9811,776not evaluable Respiratory system anomalies Ferrer, 2025 12.28[0.32; 16.47]68999not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Gouraud, 2010 Ferrer, 2025 21.40[1.17; 1.68]9,5021,545not evaluable Extremely preterm (< 28 weeks) Ferrer, 2025 10.39[0.06; 2.81]2661,446not evaluable Low birth weight (< 2500g) Gouraud, 2010 10.63[0.19; 2.07]34151not evaluable Macrosomia (> 4000g) Gouraud, 2010 10.57[0.26; 1.25]85151not evaluable Small for gestational age (weight) Ferrer, 2025 11.01[0.84; 1.21]14,1701,257not evaluable Very preterm (28 to 32 weeks) Ferrer, 2025 11.30[0.71; 2.35]9011,446not evaluable Long term consequences Tumors in infants Bowie, 2022 14.71[1.98; 11.19]891781not evaluable Intrauterine deaths Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Gouraud, 2010 Sørensen, 2022 Ferrer, 2025 31.92[1.04; 3.53]12,5609,042not evaluable Late intrauterine deaths (> 22 weeks) / Stillbirths Gouraud, 2010 Ferrer, 2025 23.70[0.58; 23.74]3291,753not evaluable Elective/induced termination of pregnancy Gouraud, 2010 14.52[2.51; 8.15]52150not evaluable Intrauterine deaths (as a whole or unspecified) Ferrer, 2025 12.02[1.73; 2.37]9,3391,602not evaluable Therapeutic terminations of pregnancy Ferrer, 2025 11.14[0.61; 2.13]8791,602not evaluable0.050.01.0

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