Isotretinoin 20mg capsules
Requires a prescription from a doctor or prescriber
Shortage warning
Current supply issues
Low shortage warning
The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin, following a review of the impact of the measures implemented in 2023. We ask healthcare professionals to review…
Affected areas: UK
Safety information for pregnancy and breastfeeding
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Isotretinoin
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Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Isotretinoin
About EudraVigilance
Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
17 branded products available
MHRA licensed products
View all licensed products for Isotretinoin on the MHRA register
Roaccutane 20mg capsules
Isotretinoin 20mg capsules
Isotretinoin 20mg capsules
Isotretinoin 20mg capsules
Isotretinoin 20mg capsules
Isotretinoin 20mg capsules
Isotretinoin 20mg capsules
This is the NHS Drug Tariff indicative price used for reimbursement purposes. It may not reflect the price paid by patients or pharmacies.
View full Drug TariffSource: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.
WHO defined daily dose (DDD)
30 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary BNF/ATC mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(4)
Acne vulgaris: management (NG198)
Dinutuximab beta for treating neuroblastoma (TA538)
LipiFlow thermal pulsation treatment for dry eyes caused by blocked meibomian glands (MIB29)
Adalimumab for treating moderate to severe hidradenitis suppurativa (TA392)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 26 · Randomised trials: 17 · 1988–2026
Showing the 50 most relevant studies, sorted by most relevant.
Yu‐Chen Huang, Ying‐Chih Cheng
Journal of the American Academy of Dermatology, 2017
- Acne Vulgaris
- Depression
- Dermatologic Agents
Isabelle A. Vallerand, Ryan T. Lewinson, Megan S. Farris, et al.
British Journal of Dermatology, 2017
- Acne Vulgaris
- Anti-Bacterial Agents
- Mental Disorders
Y. Lee, Thomas Scharnitz, J. Muscat, et al.
JAMA dermatology, 2016
- Acne Vulgaris
- Dermatologic Agents
- Isotretinoin
Ann L. Marqueling, Lee T. Zane
Seminars in Cutaneous Medicine and Surgery, 2005
- Acne Vulgaris
- Depression
- Dermatologic Agents
Changqiang Li, Jianmei Chen, Wo Wang, et al.
BMJ Open, 2019
- Acne Vulgaris
- Depressive Disorder
- Dermatologic Agents
Scott M. Lippman, J. J. Lee, Daniel D. Karp, et al.
JNCI Journal of the National Cancer Institute, 2001
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasm Staging
Fadlo R. Khuri, J. Jack Lee, Scott M. Lippman, et al.
JNCI Journal of the National Cancer Institute, 2006
- Antineoplastic Agents
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
John Lee, Scott M. Lippman, Steven E. Benner, et al.
Journal of Clinical Oncology, 1994
- Bronchi
- Epithelium
- Lung Neoplasms
Caroline Sousa Costa, Ediléia Bagatin, Ana Luiza Cabrera Martimbianco, et al.
Cochrane Database of Systematic Reviews, 2018
- Anti-Bacterial Agents
- Dermatologic Agents
- Isotretinoin
Olivia Lamberg, Arianna Strome, Foster Jones, et al.
Journal of Dermatological Treatment, 2023
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
83 found
Half-life
7-39 hours
Mechanism
Isotretinoin produces its effects through altering progress through the cell cyc…
Food interactions
3 warnings
Human targets
2 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
74-511ng/mL
[A179089]…
Half-life
7-39 hours
[A179089]…
Protein binding
99.9%
Volume of distribution
85L
[L6589]…
Metabolism
[A179116]…
Elimination
53-74%
Clearance
15.9L/h
[A179107]…
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 917 interactions
[A179113]
The oral lowest dose causing toxic effect (TDLO) for children is 30mg/kg/21W, oral TDLO for men is 24mg/kg/4W, oral TDLO for women is 56mg/kg/8W.
[L6592]
The intraperitoneal LD50 for rats is 901mg/kg, oral LD50 for mice is 3389mg/kg, oral LD50 for rats is >4000mg/kg.
[L6592]
Isotretinoin is associated with major congenital malformations, spontaneous abortion, and premature birth.[Label] It is unknown if isotretinoin is expressed in breast milk but due to the associated hazards a decision should be made to either stop nursing or stop taking isotretinoin.[Label]
In animal studies, isotretinoin was associated with an increased risk of pheochromocytoma and adrenal medullary hyperplasia at doses above the recommended clinical dose.[Label] Isotretinoin was negative for the Ames test of mutagenicity once and weakly positive a second time.[Label] It has not been shown to be clastogenic.[Label] A study in dogs noted testicular atrophy after doses of 10-30 times the recommended clinical dose for 30 weeks.[Label] In trials with men there were no effects seen on sperm count, motility, morphology, ejaculate volume, and seminal plasma fructose.[Label]
There is preliminary evidence suggesting isotretinoin may interact with FoxO1, which may explain a substantial number of isotretinoin's unexplained actions.[A179122]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A179089]
Isotretinoin is better absorbed with a high fat meal and bioavailability may change from one brand to another.[Label]
Following a 40mg oral dose, fasted subjects reached a maximum concentration of 314ng/mL in 2.9 hours with an area under the curve of 4055ng/mL\*hr.[Label] Subjects given a high fat meal and a 40mg oral doses reached a maximum concentration of 395ng/mL in 6.4 hours with an area under the curve of 6095ng/mL\*mL.[Label]
[A179089]
The half life of 4-oxo-13-cis-retinoic acid ranges from 17-50 hours with a mean elimination half life of 25 hours.
[L6589]
[L6589]
In a study of pediatric patients with neuroblastoma the volume of distribution was found to be 85L.
[A179107]
The volume of distribution was also found to be 2432mL/kg in guinea pigs and 1716mL/kg in obese rats.
[A179104]
[A179116]
Isotretinoin undergoes 4-hydroxylation to 4-hydroxy-13-cis-retinoic acid, which is oxidized to the main metabolite 4-oxo-13-cis-retinoic acid..
[A179116][A179101]
All-trans-retinoic acid undergoes 4-hydroxylation to 4-hydroxy-all-trans-retinoic acid, which is oxidized to 4-oxo-all-trans-retinoic acid.
[A179116]
4-oxo-13-cis-retinoic acid can undergo reversible cis-trans isomerization to 4-oxo-all-trans-retinoic acid.
[A179116]
[A179089]
[A179107]
Clearance is also 21.3mL/min/kg in guinea pigs and 7.2mL/min/kg in obese rats.
[A179104]
Proteins and enzymes this drug interacts with in the body
In the absence of ligand, acts mainly as an activator of gene expression due to weak binding to corepressors. Required for limb bud development. In concert with RARA or RARB, required for skeletal growth, matrix homeostasis and growth plate function (By similarity)
PMID:16417524 PMID:19850744 PMID:20215566 PMID:21152046 PMID:37478846
Retinoic acid receptors bind as heterodimers to their target response elements in response to their ligands, all-trans or 9-cis retinoic acid, and regulate gene expression in various biological processes .
PMID:21152046 PMID:28167758 PMID:37478846
The RXR/RAR heterodimers bind to the retinoic acid response elements (RARE) composed of tandem 5'-AGGTCA-3' sites known as DR1-DR5 .
PMID:19398580 PMID:28167758
In the absence of ligand, the RXR-RAR heterodimers associate with a multiprotein complex containing transcription corepressors that induce histone deacetylation, chromatin condensation and transcriptional suppression .
PMID:16417524
On ligand binding, the corepressors dissociate from the receptors and associate with the coactivators leading to transcriptional activation .
PMID:19850744 PMID:20215566 PMID:37478846 PMID:9267036
Formation of a complex with histone deacetylases might lead to inhibition of RARE DNA element binding and to transcriptional repression .
PMID:28167758
Transcriptional activation and RARE DNA element binding might be supported by the transcription factor KLF2 .
PMID:28167758
RARA plays an essential role in the regulation of retinoic acid-induced germ cell development during spermatogenesis (By similarity). Has a role in the survival of early spermatocytes at the beginning prophase of meiosis (By similarity). In Sertoli cells, may promote the survival and development of early meiotic prophase spermatocytes (By similarity).
In concert with RARG, required for skeletal growth, matrix homeostasis and growth plate function (By similarity). Together with RXRA, positively regulates microRNA-10a expression, thereby inhibiting the GATA6/VCAM1 signaling response to pulsatile shear stress in vascular endothelial cells .
PMID:28167758
In association with HDAC3, HDAC5 and HDAC7 corepressors, plays a role in the repression of microRNA-10a and thereby promotes the inflammatory response PMID:28167758
Enzymes involved in drug metabolism — important for understanding drug interactions
Proteins that carry this drug through the body
PMID:19021548
Major calcium and magnesium transporter in plasma, binds approximately 45% of circulating calcium and magnesium in plasma (By similarity).
Potentially has more than two calcium-binding sites and might additionally bind calcium in a non-specific manner (By similarity). The shared binding site between zinc and calcium at residue Asp-273 suggests a crosstalk between zinc and calcium transport in the blood (By similarity). The rank order of affinity is zinc > calcium > magnesium (By similarity).
Binds to the bacterial siderophore enterobactin and inhibits enterobactin-mediated iron uptake of E.coli from ferric transferrin, and may thereby limit the utilization of iron and growth of enteric bacteria such as E.coli .
PMID:6234017
Does not prevent iron uptake by the bacterial siderophore aerobactin PMID:6234017
ATC D10AD04
ATC D10AD54
ATC D10BA01
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Isotretinoin
Additional database identifiers
Drugs Product Database (DPD)
5044
ChemSpider
4445539
BindingDB
50031459
ZINC
ZINC000003792789
HUGO Gene Nomenclature Committee (HGNC)
HGNC:9866
GenAtlas
RARG
GeneCards
RARG
GenBank Gene Database
M24857
GenBank Protein Database
306887
Guide to Pharmacology
592
UniProt Accession
RARG_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:9864
GenAtlas
RARA
GeneCards
RARA
GenBank Gene Database
X06614
GenBank Protein Database
36157
Guide to Pharmacology
590
UniProt Accession
RARA_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2637
GenAtlas
CYP3A4
GeneCards
CYP3A4
GenBank Gene Database
M18907
Guide to Pharmacology
1337
UniProt Accession
CP3A4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:399
GenAtlas
ALB
GeneCards
ALB
GenBank Gene Database
V00494
GenBank Protein Database
28590
UniProt Accession
ALBU_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite the following publications:
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Structured knowledge from the free knowledge base
Linked open data from Wikidata (Q287029), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication. WHO INN from the World Health Organization.