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Systemic retinoid (Vitamin A derivative) Pregnancy: Highly teratogenic — contraindicated in pregnancy and in every woman of childbearing potential unless all conditions of the Pregnancy Prevention Programme are met. Effective contraception (preferably 2 complementary methods, or one highly effective user-independent method) must be used without interruption for 4 weeks (1 month) before, throughout, and for 3 years after stopping treatment. A negative pregnancy test (minimum sensitivity 25 mIU/mL) is required up to three days before the first dose; pregnancy tests at 28-day intervals during therapy and at 1-3 monthly intervals for 3 years after the last dose. Therapy should not begin until the second or third day of the next normal menstrual period. Contraindicated in women who are breast-feeding.

Acitretin

Brand names: Neotigason

Acitretin is an oral systemic retinoid used for severe, treatment-resistant psoriasis and certain disorders of keratinisation.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Initial daily dose 25 mg or 30 mg for 2 to 4 weeks, then titrate; in general a daily dosage of 25 to 50 mg for a further 6 to 8 weeks achieves optimal therapeutic results
Route: Oral
Frequency: Once daily, taken with meals or with milk
Max: It may be necessary in some cases to increase the dose up to a maximum of 75 mg/day. In severe congenital ichthyosis and severe Darier's disease requiring therapy beyond 3 months, the lowest effective dosage, not exceeding 50 mg/day, should be given. Continuous use beyond 6 months is contraindicated.
Source: UK SPC (eMC) for Acitretin (Neotigason) 10 mg Capsules, §4.2 (https://www.medicines.org.uk/emc/product/10248/smpc). Acitretin should only be prescribed by physicians who are experienced in the use of systemic retinoids and who understand the risk of teratogenicity. There is wide variation in the absorption and rate of metabolism of acitretin, so dosage must be individually adjusted and the recommendations above serve only as a guide. After the initial 2 to 4 week treatment period the involved areas of skin should show a marked response and/or side effects should be apparent; titrate the dose upwards or downwards to achieve the desired therapeutic response with the minimum of side effects. The maintenance dose must be based on clinical efficacy and tolerability. In patients with Darier's disease a starting dose of 10 mg may be appropriate, and the dose should be increased cautiously as isomorphic reactions may occur. Therapy can be discontinued in patients with psoriasis whose lesions have improved sufficiently; relapses should be treated as described above. ELDERLY: dosage recommendations are the same as for other adults. COMBINATION THERAPY: other dermatological therapy, particularly keratolytics, should normally be stopped before administration; topical corticosteroids or bland emollient ointment may be continued if indicated; when used in combination with other types of therapy it may be possible to reduce the acitretin dosage depending on individual response. §4.5 was not retrieved in this bundle — the interactions listed are those stated in §4.3; verify the full §4.5.

Paediatric dose

Dose: 0.5 mg/kg
Route: Oral
Frequency: Once daily (daily dosage), taken with meals or with milk
Max: Higher doses (up to 1 mg/kg daily) may be necessary in some cases for limited periods, but only up to a maximum of 35 mg/day
SPC §4.2 paediatric population: 'The dosage should be established according to bodyweight. The daily dosage is about 0.5 mg/kg.' Acitretin is CONTRAINDICATED in children unless, in the opinion of the physician, the benefits significantly outweigh the risks, and should be used only when all alternative therapies have proved inadequate, in view of possible severe side effects associated with long-term treatment. The maintenance dose should be kept as low as possible in view of possible long-term side effects. Verify any paediatric use against a children's formulary.

Dose adjustments

Renal

Contraindicated in patients with severe renal impairment (§4.3); the fetched §4.2 gives no separate renal dose adjustment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Paediatric weight-based calculator

SPC §4.2 paediatric population: 'The dosage should be established according to bodyweight. The daily dosage is about 0.5 mg/kg.' Acitretin is CONTRAINDICATED in children unless, in the opinion of the physician, the benefits significantly outweigh the risks, and should be used only when all alternative therapies have proved inadequate, in view of possible severe side effects associated with long-term treatment. The maintenance dose should be kept as low as possible in view of possible long-term side effects. Verify any paediatric use against a children's formulary.

Verify in a children's formulary

Contraindications

  • Hypersensitivity to the active substance, to other retinoids or to any of the excipients
  • Pregnancy — acitretin is highly teratogenic and must not be used by women who are pregnant; also contraindicated in women of childbearing potential unless strict contraception is practised 4 weeks before, during and for 3 years after treatment
  • Breast-feeding
  • Severe hepatic or renal impairment
  • Chronic abnormally elevated blood lipid values
  • Concomitant tetracyclines (both can raise intracranial pressure); concomitant methotrexate (increased risk of hepatitis); concomitant other retinoids or vitamin A (risk of hypervitaminosis A)
  • Rare glucose-galactose malabsorption (the capsules contain glucose)
  • Continuous use beyond 6 months

Side effects

  • Very common: cheilitis, pruritus, alopecia, skin exfoliation (all over the body, particularly the palms and soles)
  • Very common: drying and inflammation of mucous membranes — conjunctivitis, xerophthalmia, epistaxis, rhinitis; dry mouth and thirst
  • Common: headache; stomatitis and gastrointestinal disorders (abdominal pain, diarrhoea, nausea, vomiting); skin fragility, sticky skin, dermatitis, abnormal hair texture, brittle nails, paronychia, erythema
  • Uncommon: dizziness, blurred vision, gingivitis, hepatitis, photosensitivity reaction, bullous dermatitis
  • Rare / very rare: peripheral neuropathy, benign intracranial hypertension, night blindness, ulcerative keratitis, jaundice
  • Not known: altered mood, psychotic disorder, hearing impairment, tinnitus, flushing, capillary leak syndrome/retinoic acid syndrome, angioedema, urticaria

Interactions

  • Tetracyclines — combined use is contraindicated as both acitretin and tetracyclines can cause increased intracranial pressure; supplementary treatment with antibiotics such as tetracyclines is therefore contraindicated
  • Methotrexate — concomitant use is contraindicated (an increased risk of hepatitis has been reported with methotrexate plus etretinate)
  • Other retinoids or vitamin A — concomitant administration is contraindicated due to the risk of hypervitaminosis A
  • §4.5 was not retrieved in this bundle — verify the full interaction section (e.g. alcohol, oral contraceptives) separately

Clinical monograph

How it works

As a vitamin A derivative it modulates epidermal cell proliferation and differentiation, normalising the abnormal keratinisation and hyperproliferation seen in psoriasis.

Prescribing in practice

  • It is a potent teratogen and is contraindicated in pregnancy, requiring reliable contraception during treatment and for an extended period afterwards under a pregnancy prevention approach.
  • It can cause hepatotoxicity and marked elevations in serum lipids, so liver function and lipids must be assessed before and during treatment.
  • Alcohol should be avoided during and for a period after therapy because it can promote conversion to a longer-lived teratogenic metabolite, and blood donation is contraindicated.

Monitoring

Monitor liver function and fasting lipids regularly, alongside pregnancy testing where applicable.

Counselling the patient

  • Effective contraception is essential during treatment and for the full advised period after stopping.
  • Avoid alcohol and do not donate blood during and after treatment as directed.
  • Expect dry lips, skin and eyes, and report visual disturbance or persistent headache.

Evidence & guidelines

Acitretin is an established systemic option for severe psoriasis, and MHRA pregnancy prevention requirements for oral retinoids govern its prescribing.

Reference: BAD Psoriasis Guidelines; MHRA Retinoid Pregnancy Prevention Programme; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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