Isotretinoin use and the risk of inflammatory bowel disease: a case-control study
Open accessAbstract
OBJECTIVES: Isotretinoin is commonly prescribed for the treatment of severe acne. Although cases of inflammatory bowel disease (IBD) have been reported in isotretinoin users, a causal association remains unproven. METHODS: We performed a case-control study using a large insurance claims database. Incident cases of IBD were identified and matched to three controls on the basis of age, gender, geographical region, health plan, and length of enrollment. Isotretinoin exposure was assessed in a 12-month period before case ascertainment. Conditional logistic regression was used to adjust for matching variables. RESULTS: The study population comprised 8,189 cases (3,664 Crohn's disease (CD), 4,428 ulcerative colitis (UC), and 97 IBD unspecified) and 21,832 controls. A total of 60 subjects (24 cases and 36 controls) were exposed to isotretinoin. UC was strongly associated with previous isotretinoin exposure (odds ratio (OR) 4.36, 95% confidence interval (CI): 1.97, 9.66). However, there was no apparent association between isotretinoin and CD (OR 0.68, 95% CI: 0.28, 1.68). Increasing dose of isotretinoin was associated with elevated risk of UC (OR per 20 mg increase in dose: 1.50, 95% CI: 1.08, 2.09). Compared with non-users, the risk of UC was highest in those exposed to isotretinoin for more than 2 months (OR 5.63, 95% CI: 2.10, 15.03). CONCLUSIONS: UC but not CD is associated with previous isotretinoin exposure. Higher dose of isotretinoin seems to augment this risk. Although the absolute risk of developing UC after taking isotretinoin is likely quite small, clinicians prescribing isotretinoin as well as prospective patients should be aware of this possible association.
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Low-certainty evidence from seven observational studies with substantial heterogeneity does not support a significant association between isotretinoin use and inflammatory bowel disease incidence, including ulcerative colitis and Crohn's disease.
“Available low certainty evidence from 7 observational studies with substantial heterogeneity do not support a significant association between isotretinoin use and IBD incidence, including ulcerative colitis and Crohn's disease.”
From Guidelines of care for the management of acne vulgaris (2024) · cites this paper as [281]
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Experimental — accuracy not yet measuredThe overall relative risk of inflammatory bowel disease between isotretinoin-exposed and unexposed groups is estimated at 1.13 (95% CI 0.89-1.43).
“The overall RR of IBD between isotretinoin-exposed and unexposed groups is estimated at 1.13 (95% confidence interval, 0.89, 1.43).”
From Guidelines of care for the management of acne vulgaris (2024) · cites this paper as [281]
The Results, under “Results of matched analyses” (page not provided), report an overall IBD odds ratio of 1.68 (95% CI 0.98–2.86) for any isotretinoin use, not the claimed relative risk of 1.13 (95% CI 0.89–1.43). The Methods, under “Statistical analysis,” specify that the study estimated odds ratios rather than relative risks. (LLM, conf=0.90)
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- Authors
- Crockett, S. D., Porter, C. Q., Martin, C. F., Sandler, R. S., & Kappelman, M. D.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Crockett, Seth D
- Venue
- American Journal of Gastroenterology
- Published
- 2010-09
- Volume
- 105
- Issue
- 9
- Pages
- 1986-1993
- ISSN
- 0002-9270 (ISSN-L)
- PMC
- PMC3073620
- OpenAlex
- W2097683008
- Semantic Scholar
- 2b88116b2779af270a004e9ddf793b5baf3ff65e
- Cited by
- 161
- References
- 42
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 7 · 2023: 5 · 2022: 5 · 2021: 3 · 2020: 16 · 2019: 9 · 2018: 9 · 2017: 6 · 2016: 14 · 2015: 13 · 2014: 9 · 2013: 31 · 2012: 10
- FWCI
- 9.62
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The American Journal of Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (T32DK007634, P30DK034987)
- National Institute of Environmental Health Sciences (P30ES010126)
- National Center for Research Resources (KL2RR025746)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Health Sciences › Medicine › Dermatology › Acne and Rosacea Treatments and Effects
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Keywords
- isotretinoin, inflammatory bowel disease, ulcerative colitis, Crohn's disease, drug safety, adverse drug reactions, acne treatment, dose-response relationship, drug exposure duration
- MeSH terms
- Acne Vulgaris, Adolescent, Adult, Child, Dermatologic Agents, Dose-Response Relationship, Drug, Female, Humans, Male, Middle Aged, Risk, Inflammatory Bowel Diseases, Isotretinoin, Logistic Models, Odds Ratio, Case-Control Studies
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