Topiramate (All indications) updated on 04-22-2025

Psychomotor developmental disorders/delay

R analysis
id Study   Lib. in paper Exposition period    Study type 
 Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S19392
R82385		 Honybun (Controls exposed to LTG) (Topiramate) (Epilepsy), 2026 Processing Speed Index (Assesses psychomotor speed across time-based tasks) - Wechsler Intelligence Scale - Children aged 3–18 years (mean age about 10 years) during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick excluded Adjustment: No extrapolated (cont. endpoint) 2.21 [0.59;8.24]
excluded (control group) 		-/11   -/23 - 11
ref
S19388
R82345		 Honybun (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Processing Speed Index (Assesses psychomotor speed across time-based tasks) - Wechsler Intelligence Scale - Children aged 3–18 years (mean age about 10 years) during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No extrapolated (cont. endpoint) 2.78 [0.86;9.05] -/19   -/19 - 19
ref
S19372
R82173		 Straub (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Coordination disorders - ICD-10 codes: F82 - Mean follow up (full cohort): 3.4 years during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed, sick Adjustment: Yes 0.59 [0.26;1.33] -/961   91/8,887 - 961
ref
S19337
R82024		 Moore (Controls exposed to LTG) (Topiramate) (Indication NOS), 2025 Gross motor disorders - Assessment offered to all children - At the 27–30 months during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 1.22 [0.56;2.66] C
excluded (control group) 		8/172   36/934 44 172
ref
S19330
R82046		 Moore (Controls unexposed, general pop) (Topiramate) (Indication NOS), 2025 Fine motor disorders - Assessment offered to all children - At the 27–30 months during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: No Matched 2.28 [1.04;4.99] C 8/172   36/1,720 44 172
ref
S16627
R69717		 Thomas (Topiramate) (Epilepsy) (Controls exposed to LTG), 2022 The motor development quotient (MODQ) - The developmental assessment scale for Indian infants (DASII) - Between 12-24 months of age (mean (SD): 15.3 (3.9) months)) during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick excluded Adjustment: No extrapolated (cont. endpoint) 1.38 [0.27;6.90]
excluded (control group) 		-/6   -/26 - 6
ref
S16628
R69719		 Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022 The motor development quotient (MODQ) - The developmental assessment scale for Indian infants (DASII) - Between 12-24 months of age (mean (SD): 15.3 (3.9) months)) during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No extrapolated (cont. endpoint) 0.51 [0.11;2.27] -/6   -/110 - 6
ref
S8615
R28765		 Rihtman (Topiramate) (Mixed indications), 2012 M-FUN (based on the assessor questionnaire) (mean age around 4 years old) at least 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No extrapolated (cont. endpoint) Matched 4.10 [0.91;18.49] -/9   -/18 - 9
ref
Total 5 studies 1.48 [0.66;3.29] 44 1,167
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF Honybun (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026Honybun, 2026 1 2.78[0.86; 9.05]-1919%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: criticalROB mesure: lowROB reporting: moderate Straub (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026Straub, 2026 2 0.59[0.26; 1.33]-96125%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: moderate Moore (Controls unexposed, general pop) (Topiramate) (Indication NOS), 2025Moore, 2025 3 2.28[1.04; 4.99]4417225%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: low Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022Thomas, 2022 4 0.51[0.11; 2.27]-615%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: lowROB reporting: moderate Rihtman (Topiramate) (Mixed indications), 2012Rihtman, 2012 5 4.10[0.91; 18.49]-915%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (5 studies) I2 = 63% 1.48[0.66; 3.29]441,1670.210.01.0ROB: A: confounding, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick) (Topiramate) (Epilepsy; 2: Controls unexposed, sick) (Topiramate) (Epilepsy; 3: Controls unexposed, general pop) (Topiramate) (Indication NOS; 4: Topiramate) (Epilepsy) (Controls unexposed, sick; 5: Topiramate) (Mixed indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.48[0.66; 3.29]441,16763%NAHonybun (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Straub (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Moore (Controls unexposed, general pop) (Topiramate) (Indication NOS), 2025 Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022 Rihtman (Topiramate) (Mixed indications), 2012 5 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.58[1.29; 5.18]441810%NAMoore (Controls unexposed, general pop) (Topiramate) (Indication NOS), 2025 Rihtman (Topiramate) (Mixed indications), 2012 2 unexposed, sickunexposed, sick 0.94[0.33; 2.70]-98661%NAHonybun (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Straub (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022 3 Tags Adjustment   - No  - No 2.05[1.00; 4.18]4420631%NAHonybun (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Moore (Controls unexposed, general pop) (Topiramate) (Indication NOS), 2025 Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022 Rihtman (Topiramate) (Mixed indications), 2012 4   - Yes  - Yes 0.59[0.26; 1.33]-961 -NAStraub (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 1 extrapolated (cont. endpoint)extrapolated (cont. endpoint) 1.86[0.57; 6.05]-3454%NAHonybun (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022 Rihtman (Topiramate) (Mixed indications), 2012 3 MatchedMatched 2.58[1.29; 5.18]441810%NAMoore (Controls unexposed, general pop) (Topiramate) (Indication NOS), 2025 Rihtman (Topiramate) (Mixed indications), 2012 2 All studiesAll studies 1.48[0.66; 3.29]441,16763%NAHonybun (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Straub (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Moore (Controls unexposed, general pop) (Topiramate) (Indication NOS), 2025 Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022 Rihtman (Topiramate) (Mixed indications), 2012 50.210.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.82.20.9270.000Honybun (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026Straub (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026Moore (Controls unexposed, general pop) (Topiramate) (Indication NOS), 2025Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022Rihtman (Topiramate) (Mixed indications), 2012

Asymetry test p-value = 0.7949 (by Egger's regression)

slope=-0.0931 (1.5957); intercept=0.8640 (3.0430); t=0.2839; p=0.7949

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 16627, 19337, 19392

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.58[1.29; 5.18]441810%NAMoore (Controls unexposed, general pop) (Topiramate) (Indication NOS), 2025 Rihtman (Topiramate) (Mixed indications), 2012 2 unexposed, sick controlsunexposed, sick controls 0.94[0.33; 2.70]8298661%NAHonybun (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Straub (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022 3 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.42[0.76; 2.64]441890%NAHonybun (Controls exposed to LTG) (Topiramate) (Epilepsy), 2026 Moore (Controls exposed to LTG) (Topiramate) (Indication NOS), 2025 Thomas (Topiramate) (Epilepsy) (Controls exposed to LTG), 2022 30.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Veroniki b (NMA) (Psychomotor developmental delay)Veroniki b (NMA) (Psychomotor developmental delay) 3.89[0.41; 24.27]NA-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT-9 metaPregmetaPreg 1.48[0.66; 3.29]63%1,167----Honybun (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Straub (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 Moore (Controls unexposed, general pop) (Topiramate) (Indication NOS), 2025 Thomas (Topiramate) (Epilepsy) (Controls unexposed, sick), 2022 Rihtman (Topiramate) (Mixed indications), 2012 50.510.01.0