Formulary
Isotretinoin: Indications, Dosing, Side Effects and Interactions
Isotretinoin clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 11 min read
Isotretinoin: Indications, Dosing, Side Effects and Interactions
Isotretinoin clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Severe acne [(such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy] (under expert supervision)**
- **Adult** (By Mouth): Initially 500 micrograms/kg daily in 1-2 divided doses, increased if necessary to 1 mg/kg daily and continued until a total cumulative dose of 120-150 mg/kg is reached-treatment may be discontinued sooner if there has been an adequate response and no new lesions for 4-8 weeks, treatment course may be repeated after a period of at least 8 weeks if relapse after first course, consider dose reduction to less than 500 micrograms/kg daily for patients at increased risk of, or experiencing, side-effects; maximum 150 mg/kg per course.
**Severe acne [(such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy] (under expert supervision) for isotretinoin**
- **Child 12-17 years** (By mouth): Initially 500 micrograms/kg daily in 1-2 divided doses, increased if necessary to 1 mg/kg daily and continued until a total cumulative dose of 120-150 mg/kg is reached-treatment may be discontinued sooner if there has been an adequate response and no new lesions for 4-8 weeks, treatment course may be repeated after a period of at least 8 weeks if relapse after first course, consider dose reduction to less than 500 micrograms/kg daily for patients at increased risk of, or experiencing, side-effects; maximum 150 mg/kg per course.
**Severe infantile acne (specialist use only) for isotretinoin**
- **Child 1-23 months** (By mouth): Initially 200 micrograms/kg daily in 1-2 divided doses, increased if necessary to 1 mg/kg daily for 16-24 weeks; maximum 150 mg/kg per course.
Cautions
Important safety information For isotretinoin MHRA/CHM advice: Isotretinoin ( Roaccutane ): rare reports of erectile dysfunction and decreased libido (October 2017) An EU-wide review has concluded that on rare occasions, oral isotretinoin, indicated for severe acne, may cause sexual side-effects, including erectile dysfunction and decreased libido. MHRA/CHM advice: Oral retinoid medicines: revised and simplified pregnancy prevention educational materials for healthcare professionals and women (June 2019) New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women and girls of childbearing potential taking oral acitretin, alitretinoin, or isotretinoin. Healthcare professionals are reminded that the use of oral retinoids is contra-indicated in pregnancy due to a high risk of serious congenital malformations, and any use in females must be within the conditions of the Pregnancy Prevention Programme (see Conception and contraception and Prescribing and dispensing information ). Neuropsychiatric reactions have been reported in patients taking oral retinoids. Healthcare professionals are advised to monitor patients for signs of depression or suicidal ideation and refer for appropriate treatment, if necessary; particular care is needed in those with a history of depression. Patients should be advised to speak to their doctor if they experience any changes in mood or behaviour, and encouraged to ask family and friends to look out for any change in mood. MHRA/CHM advice: Isotretinoin ( Roaccutane ): reminder of important risks and precautions (August 2020) The MHRA reminds healthcare professionals that isotretinoin should only be prescribed for the treatment of severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Isotretinoin should be given under the supervision of physicians with expertise in the use of systemic retinoids, and a complete understanding of the risks of therapy and monitoring requirements (including signs of depression). Healthcare professionals are also advised to counsel patients on the potential risks of isotretinoin, including neuropsychiatric reactions and sexual dysfunction. The MHRA further reminds healthcare professionals that isotretinoin is a powerful teratogen associated with a high frequency of severe and life-threatening birth defects if there is exposure in utero; females of childbearing potential must meet the conditions of the Pregnancy Prevention Programme (see Conception and contraception and Prescribing and dispensing information ). MHRA/CHM advice: Isotretinoin ( Roaccutane ): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age (October 2023) Based on recommendations from the CHM after a review of the potential psychiatric and sexual side-effects of isotretinoin, the MHRA has introduced new safety measures that healthcare professionals are advised to follow: 2 independent prescribers must agree on treatment initiation in patients under 18 years old and only for severe acne resistant to adequate courses of standard therapy; all patients must be informed of the benefits and risks of treatment and have sufficient time to reflect and ask questions before starting treatment; additional counselling requirements about potential mental health and sexual function side-effects; improved assessment and monitoring of mental health and sexual function before starting and during treatment; new roles and responsibilities, such as the lead prescriber who initiates isotretinoin must have expertise in the use of systemic retinoids and a complete understanding of the risks of treatment and monitoring requirements, and patients should be reviewed face-to-face 1 month after treatment initiation; new compulsory regulatory risk minimisation materials, such as risk acknowledgement forms, patient reminder cards, and pharmacist checklists. All healthcare professionals involved in the treatment of acne, particularly those who prescribe isotretinoin, are also advised to refer to the full details of the new requirements in the Report of the CHM Isotretinoin Implementation Advisory Expert Working Group, available at:. MHRA/CHM advice: Isotretinoin: updates to prescribing guidance and survey of services (October 2025) An addendum to the CHM Isotretinoin Implementation Advisory Expert Working Group's report has been published, to amend and clarify previous advice regarding follow-up consultations, pregnancy testing, and sexual function monitoring. Healthcare professionals are advised that: follow-up consultations may be carried out remotely if appropriate, however, the first appointment should be in person; medically supervised pregnancy testing may be performed remotely with appropriate oversight to ensure tests are performed correctly and safely; patients should be asked about sexual function at follow-up appointments, although by the third appointment, this may be brief. New clinical guidance on these topics is Survey data from services that prescribe isotretinoin for acne will be used to monitor adherence to risk minimisation measures, and inform the CHM's recommendations on the regulatory requirements of isotretinoin, whilst supporting patient access to treatment across all age groups.
Contraindications
Hyperlipidaemia; hypervitaminosis A
Side effects
Common or very common Anaemia; arthralgia; back pain; cheilitis; dry eye; eye discomfort; eye inflammation; haemorrhage; headache; increased risk of infection; myalgia; nasal dryness; neutropenia; proteinuria; skin fragility (trauma may cause blistering); skin reactions; thrombocytopenia; thrombocytosis Rare or very rare Alopecia; anxiety; arthritis; behaviour abnormal; bronchospasm; cataract; corneal opacity; depression; diabetes mellitus; dizziness; drowsiness; dry throat; epiphyses premature fusion (following long-term use of high doses); exostosis (following long-term use of high doses); gastrointestinal disorders; glomerulonephritis; hair changes; hearing impairment; hepatitis; hoarseness; hyperhidrosis; hyperuricaemia; idiopathic intracranial hypertension; inflammatory bowel disease; ligament calcification (following long-term use of high doses); lymphadenopathy; malaise; mood altered; nail dystrophy; nausea; pancreatitis; photosensitivity reaction; psychotic disorder; pyogenic granuloma; seizure; suicidal behaviours; tendinitis; tendon calcification (following long-term use of high doses); vasculitis; vision disorders Frequency not known Psychiatric disorder; rhabdomyolysis; severe cutaneous adverse reactions (SCARs); sexual dysfunction; vulvovaginal dryness Side-effects, further information Risk of pancreatitis if triglycerides above 9 mmol/litre-discontinue if uncontrolled hypertriglyceridaemia or pancreatitis. Discontinue treatment if skin peeling severe or haemorrhagic diarrhoea develops. Visual disturbances require expert referral and possible withdrawal. Psychiatric side-effects could require expert referral.
Interactions
**Other interactions (2):**
- Cases of benign intracranial hypertension (pseudotumor cerebri) have been reported with concomitant use of isotretinoin and tetracyclines.
- Concurrent administration of isotretinoin with topical keratolytic or exfoliative anti- acne agents should be avoided as local irritation may increase (see section 4.4).
Pregnancy
Important safety information For isotretinoin MHRA/CHM advice: Isotretinoin ( Roaccutane ): rare reports of erectile dysfunction and decreased libido (October 2017) An EU-wide review has concluded that on rare occasions, oral isotretinoin, indicated for severe acne, may cause sexual side-effects, including erectile dysfunction and decreased libido. MHRA/CHM advice: Oral retinoid medicines: revised and simplified pregnancy prevention educational materials for healthcare professionals and women (June 2019) New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women and girls of childbearing potential taking oral acitretin, alitretinoin, or isotretinoin. Healthcare professionals are reminded that the use of oral retinoids is contra-indicated in pregnancy due to a high risk of serious congenital malformations, and any use in females must be within the conditions of the Pregnancy Prevention Programme (see Conception and contraception and Prescribing and dispensing information ). Neuropsychiatric reactions have been reported in patients taking oral retinoids. Healthcare professionals are advised to monitor patients for signs of depression or suicidal ideation and refer for appropriate treatment, if necessary; particular care is needed in those with a history of depression. Patients should be advised to speak to their doctor if they experience any changes in mood or behaviour, and encouraged to ask family and friends to look out for any change in mood. MHRA/CHM advice: Isotretinoin ( Roaccutane ): reminder of important risks and precautions (August 2020) The MHRA reminds healthcare professionals that isotretinoin should only be prescribed for the treatment of severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Isotretinoin should be given under the supervision of physicians with expertise in the use of systemic retinoids, and a complete understanding of the risks of therapy and monitoring requirements (including signs of depression). Healthcare professionals are also advised to counsel patients on the potential risks of isotretinoin, including neuropsychiatric reactions and sexual dysfunction. The MHRA further reminds healthcare professionals that isotretinoin is a powerful teratogen associated with a high frequency of severe and life-threatening birth defects if there is exposure in utero; females of childbearing potential must meet the conditions of the Pregnancy Prevention Programme (see Conception and contraception and Prescribing and dispensing information ). MHRA/CHM advice: Isotretinoin ( Roaccutane ): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age (October 2023) Based on recommendations from the CHM after a review of the potential psychiatric and sexual side-effects of isotretinoin, the MHRA has introduced new safety measures that healthcare professionals are advised to follow: 2 independent prescribers must agree on treatment initiation in patients under 18 years old and only for severe acne resistant to adequate courses of standard therapy; all patients must be informed of the benefits and risks of treatment and have sufficient time to reflect and ask questions before starting treatment; additional counselling requirements about potential mental health and sexual function side-effects; improved assessment and monitoring of mental health and sexual function before starting and during treatment; new roles and responsibilities, such as the lead prescriber who initiates isotretinoin must have expertise in the use of systemic retinoids and a complete understanding of the risks of treatment and monitoring requirements, and patients should be reviewed face-to-face 1 month after treatment initiation; new compulsory regulatory risk minimisation materials, such as risk acknowledgement forms, patient reminder cards, and pharmacist checklists. All healthcare professionals involved in the treatment of acne, particularly those who prescribe isotretinoin, are also advised to refer to the full details of the new requirements in the Report of the CHM Isotretinoin Implementation Advisory Expert Working Group, available at:. MHRA/CHM advice: Isotretinoin: updates to prescribing guidance and survey of services (October 2025) An addendum to the CHM Isotretinoin Implementation Advisory Expert Working Group's report has been published, to amend and clarify previous advice regarding follow-up consultations, pregnancy testing, and sexual function monitoring. Healthcare professionals are advised that: follow-up consultations may be carried out remotely if appropriate, however, the first appointment should be in person; medically supervised pregnancy testing may be performed remotely with appropriate oversight to ensure tests are performed correctly and safely; patients should be asked about sexual function at follow-up appointments, although by the third appointment, this may be brief. New clinical guidance on these topics is Survey data from services that prescribe isotretinoin for acne will be used to monitor adherence to risk minimisation measures, and inform the CHM's recommendations on the regulatory requirements of isotretinoin, whilst supporting patient access to treatment across all age groups.
Breast feeding
Avoid.
Hepatic impairment
Manufacturer advises avoid-limited information available.
Renal impairment
Dose adjustments In severe impairment, reduce initial dose (e.g. 10 mg daily) and increase gradually up to 1 mg/kg daily as tolerated. M
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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