Tramadol (versus unexposed) updated on 07-09-2025

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)1.26 [1.04, 1.52]46%5 studies95,7197,467not evaluable ROB1.82 [1.23; .]
Major congenital malformations1.29 [1.04, 1.60]53%5 studies66,0597,467not evaluable ROB1.90 [1.24; .]
Congenital heart defects1.22 [0.98, 1.52]1%4 studies21,2357,352not evaluable ROB-
Digestive system anomalies1.46 [0.63, 3.39]58%3 studies2,6255,576not evaluable ROB-
Oro-facial clefts1.00 [0.51, 1.98]0%3 studies8035,576not evaluable ROB-
Urinary malformations1.76 [1.20, 2.58]0%3 studies8565,576not evaluable ROB2.92 [1.70; .]
Eye defects0.86 [0.31, 2.42]0%2 studies1254,795not evaluable ROB-
Genital anomalies0.88 [0.46, 1.69]0%2 studies4224,795not evaluable ROB-
Limb defects0.91 [0.61, 1.35]0%2 studies6164,795not evaluable ROB-
Nervous system anomalies1.94 [1.15, 3.29]0%2 studies4064,795not evaluable ROB3.30 [1.56; .]
Other anomalies/syndromes (non chromosomal)0.78 [0.40, 1.50]0%2 studies5284,795not evaluable ROB-
Abdominal wall defects2.69 [0.37, 19.41]-1 study58999not evaluable ROB-
Atrial septal defect2.28 [0.99, 5.25]-1 study1,970781not evaluable ROB-
Cardiac septal defects1.78 [1.06, 3.00]-1 study8,9071,776not evaluable ROB2.96 [1.30; .]
Club foot / Talipes equinovarus3.63 [1.78, 7.40]-1 study2,2841,776not evaluable ROB6.72 [2.96; .]
Ear, face and neck anomalies3.19 [0.44, 23.13]-1 study49999not evaluable ROB-
Genetic syndromes and microdeletions1.02 [0.33, 3.19]-1 study451999not evaluable ROB-
Hypospadias0.95 [0.36, 2.54]-1 study5,0811,776not evaluable ROB-
Minor congenital malformations1.60 [0.78, 3.28]-1 study3,774781not evaluable ROB-
Polydactyly1.77 [0.59, 5.32]-1 study1,9811,776not evaluable ROB-
Respiratory system anomalies2.28 [0.32, 16.47]-1 study68999not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.40 [1.17, 1.68]0%2 studies9,5021,545not evaluable ROB2.15 [1.60; .]
Extremely preterm (< 28 weeks)0.39 [0.06, 2.81]-1 study2661,446not evaluable ROB-
Low birth weight (< 2500g)0.63 [0.19, 2.07]-1 study34151not evaluable ROB-
Macrosomia (> 4000g)0.57 [0.26, 1.25]-1 study85151not evaluable ROB-
Small for gestational age (weight)1.01 [0.84, 1.21]-1 study14,1701,257not evaluable ROB-
Very preterm (28 to 32 weeks)1.30 [0.71, 2.35]-1 study9011,446not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Tumors in infants4.71 [1.98, 11.19]-1 study891781not evaluable ROB8.89 [3.38; .]

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.92 [1.04, 3.53]97%3 studies12,5609,042not evaluable ROB3.24 [1.24; .]
Late intrauterine deaths (> 22 weeks) / Stillbirths3.70 [0.58, 23.74]42%2 studies3291,753not evaluable ROB-
Elective/induced termination of pregnancy4.52 [2.51, 8.15]-1 study52150not evaluable ROB8.52 [4.46; .]
Intrauterine deaths (as a whole or unspecified)2.02 [1.73, 2.37]-1 study9,3391,602not evaluable ROB3.46 [2.85; .]
Therapeutic terminations of pregnancy1.14 [0.61, 2.13]-1 study8791,602not evaluable ROB-

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