Isotretinoin Actavis
Oral retinoid for severe acne – prescription only
Isotretinoin Actavis contains isotretinoin, a powerful retinoid (vitamin A derivative) used to treat severe acne that has not responded to other treatments including antibiotics. It works by dramatically reducing sebum production, normalising skin cell turnover, and reducing inflammation. Due to its potential for serious side effects – most critically severe birth defects – isotretinoin requires strict medical supervision by a dermatologist and adherence to a pregnancy prevention programme for women of childbearing potential.
Quick Facts
Key Takeaways
- Isotretinoin is the most effective treatment for severe, treatment-resistant acne, with cure rates of 80–90% after a single course of 16–24 weeks.
- The drug is a powerful teratogen: women who may become pregnant must follow a strict pregnancy prevention programme with effective contraception and regular pregnancy tests.
- Common side effects include dry skin and lips, elevated blood lipids, and musculoskeletal pain – most are dose-dependent and reversible.
- Regular blood tests are required during treatment to monitor liver function, blood lipids, and blood cell counts.
- Patients should be monitored for mood changes, as isotretinoin has been rarely associated with depression and other psychiatric effects.
What Is Isotretinoin Actavis and What Is It Used For?
Quick Answer: Isotretinoin Actavis is an oral retinoid (vitamin A derivative) prescribed for severe forms of acne that have not improved with other treatments such as antibiotics or topical therapy. It is one of the most effective acne medications available, achieving long-term clearance in the majority of patients.
Isotretinoin belongs to a group of medicines called retinoids. It is a synthetic form of vitamin A that targets all four major pathogenic factors involved in acne: excessive sebum production, abnormal follicular keratinisation, proliferation of the bacterium Cutibacterium acnes (formerly Propionibacterium acnes), and inflammation. By addressing these underlying mechanisms simultaneously, isotretinoin achieves results that no other single acne medication can match.
Isotretinoin Actavis is specifically indicated for the treatment of severe forms of acne in adults and adolescents aged 12 years and older who have reached puberty. These severe forms include nodular acne (deep, painful lumps under the skin), acne conglobata (interconnected abscesses and sinus tracts), and any acne that carries a significant risk of permanent scarring. It is considered a second-line treatment, meaning it should only be used after other therapies – including adequate courses of oral antibiotics combined with topical treatments – have failed to produce satisfactory improvement.
The remarkable efficacy of isotretinoin lies in its ability to reduce sebaceous gland size and sebum output by up to 90%. This dramatic reduction in the oily secretion that feeds acne-causing bacteria creates an environment in which breakouts become far less likely. Furthermore, the effects of isotretinoin persist long after treatment is completed, which is why many patients experience lasting clearance after a single course. Clinical studies report cure rates of approximately 80–90% following one full course of treatment.
Treatment with Isotretinoin Actavis must always be initiated and supervised by a dermatologist or a physician experienced in the use of systemic retinoids. This is essential because the drug requires careful patient selection, thorough pre-treatment evaluation, ongoing monitoring through blood tests, and – for women of childbearing potential – strict adherence to a pregnancy prevention programme due to the drug's severe teratogenic effects.
What Should You Know Before Taking Isotretinoin Actavis?
Quick Answer: Isotretinoin is absolutely contraindicated during pregnancy, breastfeeding, and in patients with liver disease, very high blood lipids, or hypervitaminosis A. Women of childbearing potential must follow a strict pregnancy prevention programme. All patients require regular blood monitoring.
Contraindications
You must not take Isotretinoin Actavis if any of the following conditions apply to you. It is essential to discuss your complete medical history with your prescribing dermatologist before starting treatment:
- You are pregnant or breastfeeding – isotretinoin causes severe birth defects
- You are a woman of childbearing potential and not following the pregnancy prevention programme
- You are allergic to isotretinoin, soya, peanuts, or any other ingredient in the capsules
- You have a liver disease
- You have very high blood lipid levels (cholesterol or triglycerides)
- You have hypervitaminosis A (excessive vitamin A levels)
- You are currently taking tetracycline antibiotics (risk of increased intracranial pressure)
Pregnancy and the Pregnancy Prevention Programme
Isotretinoin is one of the most potent teratogens (substances that cause birth defects) in clinical use. Even a single dose during pregnancy can cause severe malformations of the developing foetus, including defects of the brain, face, ears, eyes, heart, thymus, and parathyroid glands. The risk of miscarriage is also substantially increased.
Because of these serious risks, a rigorous Pregnancy Prevention Programme (PPP) applies to all women of childbearing potential who take isotretinoin. The core requirements of this programme are as follows:
- Understanding the risks: Your prescriber must explain the teratogenic risk in full, and you must understand why pregnancy must be avoided and how to prevent it effectively.
- Effective contraception: You must use at least one highly effective method of contraception (such as an intrauterine device or implant) or two complementary methods (such as a hormonal contraceptive pill plus condoms). Contraception must begin at least one month before starting isotretinoin, continue throughout treatment, and continue for one month after the last dose.
- Pregnancy testing: A medically supervised pregnancy test must be negative before treatment can begin. Additional pregnancy tests are required monthly during treatment and one month after stopping treatment.
- Monthly follow-up: You must attend regular follow-up appointments, ideally every month, with your prescribing physician.
- Prompt action if pregnancy occurs: If you become pregnant during treatment or within one month of stopping, you must stop isotretinoin immediately and contact your doctor urgently. Your doctor will refer you to a specialist for counselling.
Isotretinoin must not be used during breastfeeding, as it is likely to pass into breast milk and could harm the nursing infant. Women who are breastfeeding must wait until they have fully weaned their child before considering isotretinoin therapy.
The levels of retinoids present in the semen of men taking isotretinoin are too low to cause harm to their partner's unborn child. However, you must never share your medication with anyone else, and you must not donate blood during treatment or for one month after stopping, as the drug could harm an unborn child if a pregnant woman receives your blood.
Warnings and Precautions
Before and during treatment with Isotretinoin Actavis, discuss the following with your doctor:
Mental health: Isotretinoin has been associated with changes in mood and behaviour. Rarely, patients have experienced depression, anxiety, aggression, and mood swings. In very rare cases, suicidal thoughts, suicide attempts, and completed suicides have been reported. It is critically important that you inform your family and close friends that you are taking this medication so they can help identify any changes in your behaviour or mood that you yourself may not notice. If you experience any psychiatric symptoms, contact your doctor immediately.
Serious skin reactions: Rarely, isotretinoin can cause severe skin reactions including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). These may begin as round spots with central blistering, typically on the arms, hands, legs, or feet. Watch for sores in the mouth, throat, nose, or genitals, or for conjunctivitis (red, swollen eyes). If you develop any rash or these symptoms, stop isotretinoin and seek immediate medical attention.
Inflammatory bowel disease: Isotretinoin has been linked to inflammatory bowel disease. If you develop severe bloody diarrhoea, your doctor will discontinue the medication.
Liver and blood lipids: Isotretinoin can raise liver enzyme levels and frequently increases blood lipid levels including cholesterol and triglycerides. Your doctor will order blood tests before, during, and after treatment. It is advisable to avoid or minimise alcohol consumption during treatment, as both isotretinoin and alcohol place strain on the liver.
Musculoskeletal effects: Joint pain, muscle pain, and back pain are common during treatment, particularly in adolescents who engage in vigorous physical activity. You should reduce intense exercise while taking isotretinoin. In rare cases, rhabdomyolysis (breakdown of muscle tissue) has been reported, especially in the context of strenuous physical activity. A condition called sacroiliitis (inflammatory back pain affecting the buttocks and lower back) has also been reported.
Eye problems: Dry eyes are very common and may make contact lens wear uncomfortable. Some patients experience reduced night vision, which can occur suddenly. Dry eyes that persist after treatment has ended have been reported. Use lubricating eye drops and consider switching to glasses during treatment.
Intracranial hypertension: In very rare cases, particularly when isotretinoin is used together with tetracycline antibiotics, increased pressure inside the skull (benign intracranial hypertension) can develop. Symptoms include persistent headache, nausea, vomiting, and visual disturbances. If these occur, stop the medication immediately and seek medical attention.
Sun sensitivity: Your skin will become more sensitive to sunlight during treatment. Avoid excessive sun exposure, do not use sunbeds or tanning lamps, and apply high-SPF sunscreen (SPF 30 or higher) before going outdoors.
Cosmetic procedures: Do not undergo waxing, dermabrasion, or laser skin treatments during treatment and for at least six months after stopping isotretinoin. These procedures can cause scarring, irritation, and skin discolouration while the skin remains sensitised by the drug.
Blood donation: You must not donate blood during treatment or for one month after stopping isotretinoin, as the drug could cause birth defects if a pregnant woman receives your blood.
Use in Children and Adolescents
Isotretinoin Actavis is not recommended for children under 12 years of age, as the safety and efficacy in this age group have not been established. The drug should not be used for pre-pubertal acne. In adolescents, special attention should be given to monitoring growth, as isotretinoin may potentially affect bone development, and to counselling about the importance of reducing intense physical activity to minimise musculoskeletal side effects.
How Does Isotretinoin Actavis Interact with Other Drugs?
Quick Answer: Isotretinoin must not be taken with tetracycline antibiotics or vitamin A supplements. It may interact with methotrexate (increased hepatotoxicity risk) and certain hormonal contraceptives. Always inform your doctor of all medications you are taking.
Drug interactions with isotretinoin can range from clinically significant to relatively minor. It is essential that you inform your prescribing doctor about all medicines you are currently taking or have recently taken, including over-the-counter medicines, supplements, and herbal products. The following table summarises the most important known interactions:
Major Interactions
| Interacting Drug | Risk | Recommendation |
|---|---|---|
| Tetracyclines (doxycycline, minocycline, tetracycline) | Increased risk of benign intracranial hypertension (pseudotumour cerebri) causing severe headache, visual disturbances, and potentially permanent vision loss | Absolutely contraindicated – never use together |
| Vitamin A supplements | Hypervitaminosis A with symptoms including headache, nausea, skin peeling, and liver damage | Do not take any vitamin A supplements during treatment |
| Methotrexate | Both drugs are hepatotoxic; combined use significantly increases the risk of liver damage | Avoid concurrent use; if necessary, monitor liver function very closely |
Minor Interactions and Precautions
| Interacting Drug/Substance | Risk | Recommendation |
|---|---|---|
| Keratolytic or exfoliative acne products (benzoyl peroxide, salicylic acid peels) | Increased skin irritation, dryness, and peeling | Avoid use during treatment; moisturisers and emollients are acceptable |
| Progestogen-only contraceptives (mini-pill) | Isotretinoin may reduce the efficacy of low-dose progestogen-only pills | Discuss alternative contraceptive methods with your doctor |
| Alcohol | Increased hepatotoxicity and elevation of triglycerides | Avoid or significantly reduce alcohol intake |
| Phenytoin | Isotretinoin may reduce phenytoin plasma levels | Monitor phenytoin levels if used concurrently |
Non-medicated moisturisers, lip balms, and emollients can and should be used freely during isotretinoin treatment, as these help manage the dryness that is a near-universal side effect of the drug. Sunscreen with a high SPF is also recommended and does not interact with the medication.
What Is the Correct Dosage of Isotretinoin Actavis?
Quick Answer: The standard starting dose is 0.5 mg/kg/day, taken with food. The dose may be adjusted to between 0.5 and 1.0 mg/kg/day depending on response and tolerability. A full treatment course typically lasts 16–24 weeks, with a target cumulative dose of 120–150 mg/kg.
Isotretinoin dosing is weight-based and individualised according to each patient's response and tolerance. The capsules should always be taken with or immediately after a meal, as food significantly improves the absorption of the drug. Capsules should be swallowed whole with a drink – do not chew or crush them.
Adults
Standard Adult Dosing
- Starting dose: 0.5 mg/kg/day (e.g., 30 mg/day for a 60 kg patient)
- Maintenance dose: 0.5–1.0 mg/kg/day, adjusted based on response and side effects
- Maximum dose: 1.0 mg/kg/day (doses above this are rarely used and increase side effect risk)
- Frequency: Once or twice daily with meals
- Target cumulative dose: 120–150 mg/kg over the entire treatment course
- Duration: Typically 16–24 weeks
After a few weeks of treatment, your doctor may adjust the dose upward or downward based on how well you are responding and whether you are experiencing significant side effects. If the recommended dose is not well tolerated, a lower dose may be used, although this may mean a longer treatment course and a higher chance of relapse.
Adolescents (12 years and older, post-puberty)
Adolescent Dosing
- Same weight-based dosing as adults: 0.5–1.0 mg/kg/day
- Special consideration: Reduce intense physical activity due to higher risk of musculoskeletal side effects
- Not recommended under 12 years of age
Patients with Kidney Problems
Renal Impairment Dosing
- Starting dose: 10 mg/day (lower starting dose)
- Titration: Gradually increased to the maximum tolerated dose
- Monitoring: More frequent kidney function tests may be required
Missed Dose
If you forget to take a dose, take it as soon as you remember – provided it is not almost time for your next scheduled dose. If it is nearly time for the next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one. Missing an occasional dose is unlikely to significantly affect the outcome of your treatment.
Overdose
If you take more isotretinoin than prescribed, or if a child accidentally ingests the medication, contact your doctor, go to your nearest emergency department, or call your national poison information centre immediately. Symptoms of isotretinoin overdose may resemble those of vitamin A toxicity, including severe headache, nausea, vomiting, drowsiness, and irritability. Treatment is supportive, as there is no specific antidote.
Most patients require only one course of treatment. Acne often continues to improve for up to 8 weeks after stopping isotretinoin, so a second course should not be considered until at least this period has elapsed. If a second course is necessary, the same dosing guidelines apply, and a minimum interval of 8 weeks between courses is recommended. It is common for acne to appear to worsen during the first few weeks of treatment before significant improvement occurs – this initial flare is temporary.
What Are the Side Effects of Isotretinoin Actavis?
Quick Answer: The most common side effects are dry skin and lips, skin sensitivity, musculoskeletal pain, eye dryness, and changes in blood lipids and liver enzymes. Serious but rare side effects include psychiatric effects, inflammatory bowel disease, and severe skin reactions. Most side effects are dose-dependent and resolve after treatment ends.
Like all medicines, isotretinoin can cause side effects, although not everyone experiences them. Many side effects are dose-dependent, meaning they are more likely at higher doses and often improve if the dose is reduced. Most side effects resolve completely when treatment is stopped, although some – such as dry eyes – may occasionally persist. The following frequency-based classification will help you understand how common different side effects are:
Very Common
Affects more than 1 in 10 people
- Dry skin, particularly on the lips and face
- Inflamed, chapped, and cracked lips (cheilitis)
- Skin rash, mild itching, and skin peeling
- Increased skin sensitivity and redness, especially on the face
- Back pain, muscle pain, and joint pain (especially in adolescents)
- Eye inflammation (conjunctivitis) and dry, irritated eyes
- Elevated liver enzymes (seen on blood tests)
- Changes in blood lipid levels (HDL cholesterol and triglycerides)
- Increased tendency to bruise, bleed, or form clots (if platelets are affected)
- Anaemia – weakness, dizziness, pale skin (if red blood cells affected)
Common
Affects up to 1 in 10 people
- Headache
- Higher cholesterol levels in the blood
- Protein or blood in the urine
- Increased susceptibility to infections (if white blood cells affected)
- Dry nose with crusting, which may lead to mild nosebleeds
- Sore or inflamed throat and nasal passages
- Elevated blood sugar levels
Uncommon to Rare
Affects up to 1 in 1,000 people
- Depression, worsening of existing depression, anxiety
- Aggression or violent behaviour
- Allergic skin reactions (rash, itching)
- Hair loss (alopecia) – usually temporary and reversible
- Severe allergic (anaphylactic) reactions – difficulty breathing, facial swelling
Very Rare to Unknown Frequency
Affects fewer than 1 in 10,000 people, or frequency unknown
- Suicidal thoughts, suicide attempts, psychosis
- Severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Hepatitis (liver inflammation) – yellowing of skin/eyes, fatigue
- Kidney inflammation – difficulty urinating, swollen eyelids, extreme fatigue
- Benign intracranial hypertension – persistent headache with nausea, vomiting, blurred vision
- Inflammatory bowel disease – severe abdominal pain with bloody diarrhoea
- Rhabdomyolysis – muscle weakness, dark urine, reduced urine output
- Sacroiliitis – inflammatory back pain in buttocks or lower back
- Impaired night vision, colour blindness, cataracts
- Diabetes mellitus (new onset)
- Seizures, drowsiness, dizziness
- Erectile dysfunction, decreased libido
- Vaginal dryness
- Gynaecomastia (breast enlargement in males)
- Excessive sweating, increased body hair
- Hearing impairment
- Inflammation of blood vessels (vasculitis)
- Severe skin rash with blistering or peeling, particularly if accompanied by sores in the mouth, throat, or eyes
- Signs of depression, suicidal thoughts, or unusual behavioural changes
- Difficulty breathing or swallowing, facial swelling (signs of severe allergic reaction)
- Persistent severe headache with nausea, vomiting, and visual changes
- Severe abdominal pain with bloody diarrhoea
- Yellowing of the skin or eyes (jaundice)
- Muscle weakness with dark urine
- Sudden blurred vision
If you experience any of the above serious side effects, stop taking Isotretinoin Actavis immediately and contact your doctor or seek emergency medical care. For less serious side effects, speak with your doctor at your next scheduled appointment – your dose may be adjusted to improve tolerability.
Can You Drive While Taking Isotretinoin Actavis?
Quick Answer: Isotretinoin may impair your ability to drive safely. Reduced night vision can occur suddenly and may persist after treatment ends. Drowsiness and dizziness have also been reported rarely.
Your ability to see clearly in low-light conditions may be impaired during treatment with isotretinoin. This effect on night vision can develop suddenly and without warning, which is particularly dangerous when driving at night or in poor visibility conditions. In rare cases, night vision impairment has persisted even after the medication was discontinued. Drowsiness and dizziness have also been reported, although very rarely.
You are personally responsible for assessing whether you are fit to drive a vehicle or operate machinery. If you notice any reduction in your vision – particularly in dim light – or if you experience drowsiness or dizziness, do not drive or operate heavy machinery. Discuss any concerns about your fitness to drive with your prescribing physician.
How Should You Store Isotretinoin Actavis?
Quick Answer: Store in the original packaging to protect from light, at room temperature. Keep out of reach of children. Return unused capsules to a pharmacy for safe disposal.
Proper storage of isotretinoin is important to ensure the medication remains effective and to prevent accidental exposure, particularly by children or pregnant women. Follow these guidelines:
- Keep out of sight and reach of children – this is especially important given the drug's teratogenic potential
- Store in the original blister packaging inside its outer carton to protect from light, as isotretinoin is light-sensitive
- Check the expiry date on the carton and blister pack before taking each dose; do not use after the expiry date
- Store at room temperature – no special temperature requirements, but avoid extreme heat or humidity
- Do not dispose of in household waste or wastewater – return any unused or expired capsules to your pharmacy for environmentally safe disposal
- Only keep unused capsules if your doctor advises you to do so; otherwise, return all remaining medication to the pharmacy at the end of treatment
What Does Isotretinoin Actavis Contain?
Quick Answer: Each capsule contains isotretinoin as the active ingredient (10 mg or 20 mg). The capsules contain refined soybean oil and the colouring agent Ponceau 4R (E124), which may cause allergic reactions in susceptible individuals.
Active Ingredient
The active substance is isotretinoin. Isotretinoin Actavis is available in two strengths: each 10 mg capsule contains 10 mg of isotretinoin, and each 20 mg capsule contains 20 mg of isotretinoin.
Other Ingredients
Capsule contents: Refined soybean oil, all-rac-alpha-tocopherol (vitamin E), disodium edetate, butylated hydroxyanisole, hydrogenated vegetable oil, partially hydrogenated soybean oil, yellow beeswax.
10 mg capsule shell: Gelatin, glycerol (98–101%), liquid sorbitol (5.31 mg per capsule), purified water, Ponceau 4R (E124), black iron oxide (E172), titanium dioxide (E171).
20 mg capsule shell: Gelatin, glycerol (98–101%), liquid sorbitol (16.99 mg per capsule), purified water, Ponceau 4R (E124), indigo carmine (E132), titanium dioxide (E171).
- Soybean oil: This product contains refined soybean oil. If you are allergic to peanuts or soya, do not use this medicine.
- Ponceau 4R (E124): This colouring agent may cause allergic reactions in susceptible individuals.
- Sodium content: This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is essentially sodium-free.
- Sorbitol: The capsules contain small amounts of sorbitol (5.31 mg per 10 mg capsule; 16.99 mg per 20 mg capsule).
Capsule Appearance and Pack Sizes
10 mg capsules: Light purple, oval, soft gelatin capsules (10 mm × 7 mm) containing a yellow/orange, opaque, viscous liquid.
20 mg capsules: Reddish-brown, oval, soft gelatin capsules (13 mm × 8 mm) containing a yellow/orange, opaque, viscous liquid.
Available pack sizes: 10, 20, 30, 60, 90, and 100 capsules for both strengths. Not all pack sizes may be marketed in all countries.
Frequently Asked Questions About Isotretinoin Actavis
References and Sources
All information on this page is based on peer-reviewed medical literature, approved prescribing information, and international clinical guidelines. The following sources were used:
- European Medicines Agency (EMA). Isotretinoin – Summary of Product Characteristics. EMA/CHMP. Available at: www.ema.europa.eu
- Layton AM, et al. A review of the evidence base for isotretinoin in acne. British Journal of Dermatology. 2023;189(Suppl 1):i26–i36. doi:10.1093/bjd/ljad265
- Zaenglein AL, et al. Guidelines of care for the management of acne vulgaris. Journal of the American Academy of Dermatology. 2016;74(5):945–973.e33. doi:10.1016/j.jaad.2015.12.037
- British Association of Dermatologists (BAD). Guidelines for safe prescribing of isotretinoin. BAD 2024. Available at: www.bad.org.uk
- U.S. Food and Drug Administration (FDA). Isotretinoin Prescribing Information and iPLEDGE Programme. FDA. Available at: www.fda.gov
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
- Vallerand IA, et al. Risk of depression and suicidality with isotretinoin treatment: A systematic review and meta-analysis. JAMA Dermatology. 2018;154(10):1137–1145. doi:10.1001/jamadermatol.2018.3516
- Rademaker M, et al. Isotretinoin: dose, duration and relapse. What does 30 years of usage tell us? Australasian Journal of Dermatology. 2013;54(3):157–162. doi:10.1111/j.1440-0960.2012.00947.x
Medical Editorial Team
This article was written and reviewed by iMedic's medical editorial team, which includes specialists in dermatology, pharmacology, and clinical medicine. All content follows the GRADE evidence framework and is based on the highest available level of evidence (Level 1A where applicable).
Written by qualified medical professionals with expertise in dermatology and pharmacology. All claims are referenced to peer-reviewed literature and approved prescribing information.
Independently reviewed by the iMedic Medical Review Board. Reviewed for clinical accuracy, completeness, and adherence to current international guidelines (EMA, FDA, BAD, WHO).
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