Acetaminophen (Paracetamol) updated on 11-25-2025

Table   Graphic     exposition period:

Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Gastroschisis1.21 [0.97, 1.51]34%7 studies96131,313not evaluable ROB-
All congenital malformations (majors, minors, majors and minors, or unspecified)1.09 [0.93, 1.29]82%6 studies64,59439,950not evaluable ROB-
Composite criterion: malformations of the genital system (cryptorchidism or hypospadias or clitoral hypertrophy or labial fusion, …)0.98 [0.88, 1.08]0%7 studies2,83842,634not evaluable ROB-
Cryptorchidism / Undescended testicle (minor malformation)1.04 [0.88, 1.23]9%5 studies1,11412,808not evaluable ROB-
Major congenital malformations1.09 [0.93, 1.27]86%4 studies63,50339,543not evaluable ROB-
Congenital heart defects1.05 [0.97, 1.15]0%3 studies1,16863,333not evaluable ROB-
Hypospadias0.94 [0.80, 1.10]9%3 studies1,72429,826not evaluable ROB-
Cleft palate1.23 [0.90, 1.70]46%3 studies1,29928,669not evaluable ROB-
Congenital constriction bands/amniotic band1.32 [0.74, 2.35]72%2 studies1979,013not evaluable ROB-
Neural Tube Defects1.32 [0.49, 3.54]23%2 studies8172,295not evaluable ROB-
Respiratory system anomalies1.46 [0.69, 3.10]63%2 studies11535,014not evaluable ROB-
Atresia or stenosis of other parts of small intestine0.96 [0.61, 1.49]0%2 studies15026,801not evaluable ROB-
Cardiac septal defects1.04 [0.94, 1.15]0%2 studies2,52529,390not evaluable ROB-
Cleft lip with or without cleft palate1.27 [0.62, 2.60]67%2 studies2,4842,472not evaluable ROB-
Congenital cataract0.85 [0.60, 1.20]0%2 studies15627,853not evaluable ROB-
Congenital glaucoma1.61 [0.81, 3.22]71%2 studies4135,925not evaluable ROB-
Craniosynostosis1.01 [0.84, 1.21]0%2 studies57628,620not evaluable ROB-
Eye defects1.24 [0.81, 1.88]70%2 studies4,29231,048not evaluable ROB-
Nervous system anomalies0.85 [0.61, 1.19]0%2 studies91526,465not evaluable ROB-
Oro-facial clefts1.03 [0.92, 1.16]0%2 studies1,86229,136not evaluable ROB-
Spina bifida0.83 [0.42, 1.63]59%2 studies47328,587not evaluable ROB-
Ventricular septal defect0.99 [0.87, 1.13]0%2 studies1,16628,788not evaluable ROB-
Eye, ear, face and neck malformations1.82 [1.11, 2.99]-1 study7026,424not evaluable ROB3.04 [1.46; .]
33 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)1.05 [0.82, 1.33]90%10 studies15,79127,511low ROB-
Low birth weight (< 2500g)1.10 [0.83, 1.45]78%8 studies12,14526,123serious ROB-
Small for gestational age (weight)0.96 [0.91, 1.01]0%5 studies6,1931,518not evaluable ROB-
Macrosomia (> 4000g)1.24 [0.71, 2.16]80%2 studies16,02124,597not evaluable ROB-
1 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preeclampsia1.27 [0.86, 1.87]73%2 studies1,20319,630not evaluable ROB-
Caesarean1.29 [1.09, 1.54]-1 study7121,011not evaluable ROB1.91 [1.39; .]

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low Apgar score (< 7) (at 5 min)1.55 [0.92, 2.62]84%3 studies3,08125,536not evaluable ROB-
Low Apgar score (< 7) (at 1 min)1.90 [0.73, 4.95]89%2 studies17,83924,531not evaluable ROB-
Neonatal medical care1.45 [1.38, 1.52]0%2 studies15,08921,309not evaluable ROB2.25 [2.10; .]
Cerebral palsy1.34 [1.05, 1.72]-1 study29290,830not evaluable ROB2.01 [1.26; .]
Low Apgar score (< 7) (at 10 min)3.18 [1.58, 6.41]-1 study60501not evaluable ROB5.81 [2.53; .]
Neonatal death (< 28 days of life)1.56 [1.24, 1.96]-1 study49023,704not evaluable ROB2.49 [1.79; .]
2 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Childhood asthma1.34 [1.18, 1.52]59%7 studies26,94515,601not evaluable ROB2.01 [1.63; .]
Childhood wheezing1.24 [1.09, 1.42]22%6 studies1,7828,539not evaluable ROB1.79 [1.40; .]
Infant allergies1.18 [0.86, 1.63]47%3 studies2,5465,331not evaluable ROB-
Leukemia1.04 [0.72, 1.50]0%2 studies504426not evaluable ROB-
Child/Infant weight abnormalities (>= 1 year)1.06 [0.98, 1.16]0%2 studies2,18713,681not evaluable ROB-
2 non statistically significant endpoints reported in only one study

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.03 [0.92, 1.15]0%3 studies2,727563not evaluable ROB-
Late intrauterine deaths (> 22 weeks) / Stillbirths1.21 [0.84, 1.73]92%4 studies1,68424,699not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.16 [1.09, 1.24]61%8 studies162,443323,950serious ROB1.60 [1.40; .]
ADHD (Attention deficit hyperactivity disorder): Diagnosis1.16 [1.07, 1.25]68%6 studies161,166321,989serious ROB1.58 [1.35; .]
ASD (Autism spectrum disorder): Diagnosis1.07 [1.02, 1.13]42%3 studies69,611264,219not evaluable ROB1.35 [1.15; .]
ASD (Autism spectrum disorder): Diagnosis/Risk1.07 [1.02, 1.13]42%3 studies69,611264,219not evaluable ROB1.35 [1.15; .]
Language disorders/delay1.00 [0.99, 1.01]0%5 studies1,4305,316not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Risk1.15 [1.06, 1.24]0%3 studies3,06923,631not evaluable ROB1.56 [1.31; .]
Cognitive developmental disorders/delay (3-6 years old)1.07 [0.96, 1.19]5%2 studies43,004not evaluable ROB-
Psychomotor developmental disorders/delay1.04 [0.82, 1.31]76%3 studies3214,100not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)0.93 [0.83, 1.03]0%2 studies2,470not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)1.05 [1.00, 1.10]-1 study24,554185,909not evaluable ROB1.28 [1.03; .]
Neuro-developmental disorders (as a whole)1.08 [1.01, 1.16]-1 study42,123not evaluable ROB1.37 [1.10; .]
Severe cognitive developmental delay (Mental retardation) (> 6 years old)1.05 [1.00, 1.10]-1 study24,554185,909not evaluable ROB1.28 [1.03; .]
ASD (Autism spectrum disorder): Risk1.28 [1.10, 1.49]-1 study72934,584not evaluable ROB1.88 [1.43; .]
2 non statistically significant endpoints reported in only one study

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