Acne Treatments

Find Acne Treatments

Generic Name

ISOtretinoin

Brand Names

Absorica, Accutane, Amnesteem, Claravis, Zenatane

FDA approval date: November 11, 2002

Classification: Retinoid

Form: Capsule

What is Absorica (ISOtretinoin)?

ABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use : If a second course of ABSORICA/ABSORICA LD therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration.

Approved To Treat

Acne

Top Global Experts

View All

Save this treatment for later

Not sure about your diagnosis?

Check Your Symptoms

Tired of the same old research?

Check Latest Advances

Related Clinical Trials

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma

Enrollment Status: Recruiting

Publish Date: June 17, 2026

Intervention Type: Procedure, Drug, Other, Biological, Radiation

Study Phase: Phase 3

Summary: This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neur...

A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age

Enrollment Status: Recruiting

Publish Date: June 08, 2026

Intervention Type: Drug

Study Phase: Early Phase 1

Summary: Pilot study to determine feasibility of adding intrathecal chemotherapy and maintenance therapy after high dose chemotherapy for treatment of newly diagnosed HR-EBTs in patients less than 6 years of age.

Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study

Enrollment Status: Recruiting

Publish Date: May 20, 2026

Intervention Type: Drug

Study Phase: Phase 3

Summary: In Dermatology, assessment of people of color remains underrepresented in RCTs (\<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in m...

View All Clinical Trials

Related Latest Advances

Low-Dose Isotretinoin: An Option for the Treatment of Scalp and Facial Rosacea.

Journal: The Journal of clinical and aesthetic dermatology

Published: June 04, 2026

Oral isotretinoin and acne clearance: the role of daily dosage in a real-world clinical setting.

Journal: Italian journal of dermatology and venereology

Published: May 21, 2026

Isotretinoin Treatment in Adolescence and Adult Height.

Journal: JAMA dermatology

Published: May 20, 2026

View All Latest Advances

Brand Information

Absorica (isotretinoin)

WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY

ABSORICA/ABSORICA LD can cause life-threatening birth defects and is contraindicated in pregnancy.

There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of ABSORICA/ABSORICA LD even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. If pregnancy occurs, discontinue ABSORICA/ABSORICA LD immediately and refer the patient to an Obstetrician- Gynecologist experienced in reproductive toxicity for further evaluation and counseling

Because of the risk of embryo-fetal toxicity, ABSORICA and ABSORICA LD are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS

1INDICATIONS AND USAGE

Limitations of Use

If a second course of ABSORICA/ABSORICA LD treatment is needed, it is not recommended before a 2-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of treatment

2DOSAGE FORMS AND STRENGTHS

ABSORICA and ABSORICA LD have different dosage regimens

ABSORICA is available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg capsules.

10 mg: Dark yellow, opaque, capsule imprinted with black ink “G240” on cap and “10” on the body
20 mg: Red, opaque, capsule imprinted with black ink “G241” on cap and “20” on the body
25 mg: Green, opaque, capsule imprinted with white ink “G342” on cap and “25” on the body
30 mg: Brown, opaque, capsule imprinted with white ink “G242” on cap and “30” on the body
35 mg: Dark blue, opaque, capsule imprinted with white ink “G343” on cap and “35” on the body
40 mg: Brown and red, capsule imprinted with white ink “G325” on cap and “40” on the body

ABSORICA LD is available in 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg opaque-printed, hard-gelatin capsules.

8 mg: A size 3, light green with a colorless band (the cap is printed in white with “RL29” and the body is printed in white with “RL29”).
16 mg: A size 2, dark blue with a colorless band (the cap is printed in white with “RL30” and the body is printed in white with “RL30”).
20 mg: A size 1, dark pink with a colorless band (the cap is printed in black with “RL33”and the body is printed in black with “RL33”).
24 mg: A size 1, yellow with a colorless band (the cap is printed in white with “RL31” and the body is printed in white with “RL31”).
28 mg: A size 0, light blue, with a colorless band (the cap is printed in black with “RL34” and the body is printed in black with “RL34”).
32 mg: A size 0, caramel with a colorless band (the cap is printed in white with “RL32” and the body is printed in white with “RL32”).

3CONTRAINDICATIONS

ABSORICA/ABSORICA LD is contraindicated in:

Pregnancy
Patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred)

4ADVERSE REACTIONS

The following adverse reactions with ABSORICA/ABSORICA LD or other isotretinoin capsule products are described in more detail in other sections of the labeling:

Embryo-Fetal Toxicity
Psychiatric Disorders
Intracranial Hypertension (Pseudotumor Cerebri)
Serious Skin Reactions
Pancreatitis
Lipid Abnormalities
Hearing Impairment
Hepatotoxicity
Inflammatory Bowel Disease
Musculoskeletal Abnormalities
Ocular Abnormalities
Hypersensitivity Reactions

The following adverse reactions associated with the use of isotretinoin capsules were identified in clinical trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dose Relationship

Cheilitis and hypertriglyceridemia were dose related.

Body as a Whole

Fatigue, irritability, pain, allergic reactions, systemic hypersensitivity, edema, lymphadenopathy, weight loss.

Cardiovascular

Vascular thrombotic disease, stroke, palpitation, tachycardia.

Endocrine/Metabolism and Nutritional

Decreased appetite, weight fluctuation, alterations in blood sugar.

Gastrointestinal

Dry lips, chapped lips, cheilitis, nausea, constipation, diarrhea, abdominal pain, vomiting, inflammatory bowel disease,

hepatitis, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis, esophageal ulceration, ileitis.

Hematologic

Anemia and decreased RBC parameters, thrombocytopenia, increased platelet counts, decreased WBC counts, severe neutropenia, rare reports of agranulocytosis.

Infections and Infestations

Nasopharyngitis, hordeolum, infections (including disseminated herpes simplex and upper respiratory tract infection).

Laboratory Abnormalities

The following lab tests were increased: creatine phosphokinase (CPK), triglycerides, alanine aminotransferase (SGPT), aspartate aminotransferase (SGOT), gamma-glutamyltransferase (GGTP), cholesterol, low density lipoprotein (LDL), alkaline phosphatase, bilirubin, LDH, fasting blood glucose, uric acid, and sedimentation rate. However, high density lipoprotein (HDL) was decreased. Urine findings included increased white cells, proteinuria, microscopic or gross hematuria.

Musculoskeletal and Connective Tissue

Decreases in bone mineral density, musculoskeletal symptoms (sometimes severe) including back pain, arthralgia, musculoskeletal pain, neck pain, extremity pain, myalgia, musculoskeletal stiffness

Neurological

Headache, syncope, intracranial hypertension (pseudotumor cerebri), dizziness, drowsiness, lethargy, malaise, nervousness, paresthesia, seizures, stroke, weakness.

Psychiatric

Suicidal ideation, insomnia, anxiety, depression, irritability, panic attack, anger, violent behaviors, emotional instability, suicide attempts, suicide, aggression, psychosis and auditory hallucinations. Of the patients reporting depression, some reported that the depression subsided with discontinuation of treatment and recurred with reinstitution of treatment.

Reproductive System

Abnormal menses, sexual dysfunction, including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness.

Respiratory

Epistaxis, nasal dryness, bronchospasm (with or without a history of asthma), respiratory infection, voice alteration.

Skin and Subcutaneous Tissue

Dry skin, dermatitis, eczema, rash, contact dermatitis, alopecia, pruritus, sunburn, erythema, acne fulminans, alopecia(which in some cases persisted), bruising, dry nose, eruptive xanthomas, erythema multiforme, flushing, skin fragility, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, increased sunburn susceptibility, sweating, toxic epidermal necrolysis, urticaria,vasculitis (including granulomatosis with polyangiitis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting).

Senses

Hearing: tinnitus and hearing impairment.

Ocular: dry eyes, reduced visual acuity, blurred vision, eye pruritis, eye irritation, asthenopia, decreased night vision, ocular hyperemia, increased lacrimation, conjunctivitis, corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, eyelid inflammation, keratitis, optic neuritis, photobia, visual disturbances.

Renal and Urinary

Glomerulonephritis.

5OVERDOSAGE

Isotretinoin overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolved without apparent residual effects.

Evaluate patients who can become pregnant who present with an ABSORICA/ABSORICA LD overdosage for pregnancy. Because an overdosage would be expected to result in higher levels of isotretinoin in semen than found during a normal treatment course, instruct male patients treated with ABSORICA/ABSORICA LD to use a condom, or avoid reproductive sexual activity with a patient who is or might become pregnant, for 1 month after the overdose.

Instruct all patients with ABSORICA/ABSORICA LD overdose to not donate blood for at least 1 month. If an overdose occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

6DESCRIPTION

ABSORICA

ABSORICA (isotretinoin) Capsules contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems:

•10 mg – iron oxide (yellow) and titanium dioxide;

•20 mg – iron oxide (red), and titanium dioxide;

•25 mg – FD&C Blue #1, FD&C Yellow #5

•30 mg – iron oxide (black, red and yellow) and titanium dioxide;

•35 mg – FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide;

•40 mg – iron oxide (black, red and yellow) and titanium dioxide.

ABSORICA LD

ABSORICA LD (isotretinoin) Capsules contain 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg of micronized isotretinoin (a retinoid) in suspension filled in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, USP each capsule contains the following inactive ingredients: butylated hydroxy anisole, gelatin, hard gelatin capsule shell, polysorbate 80 and soybean oil. The gelatin capsules contain the following dye systems:

•8 mg – D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and titanium dioxide

•16 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide

•20 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide

•24 mg – D&C Yellow #10, FD&C Yellow #6 and titanium dioxide

•28 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide

•32 mg – ferrosoferric oxide, ferric oxide (red and yellow) and titanium dioxide

The imprinting ink of 8 mg, 16 mg, 24 mg and 32 mg capsules contain the following ingredients: potassium hydroxide, propylene glycol, shellac and titanium dioxide.

The imprinting ink of 20 mg and 28 mg capsules contain the following ingredients: ferrosoferric oxide, propylene glycol and shellac glaze.

Isotretinoin

Chemically, isotretinoin is 13-

ABSORICA meets USP Dissolution Test 3.

For ABSORICA LD, FDA approved dissolution test differs from the USP.

7CLINICAL STUDIES

The effectiveness of ABSORICA/ABSORICA LD for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older has been established and is based on a double-blind, randomized, parallel group trial (Study 1) in subjects with severe recalcitrant nodular acne who received ABSORICA or another isotretinoin capsule product under fed conditions. A total of 925 subjects were randomized 1:1 to receive ABSORICA or another isotretinoin capsule product. Study subjects ranged from 12 to 54 years of age (including 397 pediatric subjects 12 years of age and older); 60% were male, 40% were female; and the racial groups included 87% White, 4% Black, 6% Asian, and 3% Other. Enrolled subjects had a weight of 40 to 110 kg and had at least 10 nodular lesions on the face and/or trunk. Subjects were treated with an initial dose of 0.5 mg/kg/day in two divided doses for the first 4 weeks, followed by 1 mg/kg/day in two divided doses for the following 16 weeks.

Change from baseline to Week 20 in total nodular lesion count and proportion of subjects with at least a 90% reduction in total nodular lesion count from baseline to Week 20 are presented in Table 3. Total nodular lesion counts by visit are presented in Figure 1. A single course of ABSORICA and another isotretinoin capsule product treatment for 15 to 20 weeks has been shown to result in complete and prolonged remission of acne in many patients.

Table 3: Efficacy Results in Subjects with Severe Recalcitrant Nodular Acne at Week 20 (Study 1)

Figure 1: Total Nodular (Facial and Truncal) Lesion Count in Subjects with Severe Recalcitrant Nodular Acne by Visit in Study 1

* Another isotretinoin capsule product.

8HOW SUPPLIED/STORAGE AND HANDLING

ABSORICA and ABSORICA LD have different dosage regimens. Although ABSORICA and ABSORICA LD have a 20 mg strength, these strengths have different bioavailability and are not substitutable

ABSORICA

ABSORICA (isotretinoin) Capsules (opaque) are supplied as follows:

10 mg
Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-115-31
20 mg
Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-116-31
25 mg
30 mg
35 mg
40 mg

ABSORICA LD

ABSORICA LD (isotretinoin) Capsules (opaque-printed, hard-gelatin) are supplied as follows:

8 mg: A size 3, light green, capsules banded with a colorless band. The cap is printed in white with “RL29” and the body is printed in white with “RL29”.

Box of 30 capsules (3 x 10 Prescription Packs) NDC 10631-002-31

16 mg: A size 2, dark blue, capsules banded with a colorless band. The cap is printed in white with “RL30” and the body is printed in white with “RL30”.

Box of 30 capsules (3 x 10 Prescription Packs) NDC 10631-003-31

20 mg: A size 1, dark pink, capsules banded with a colorless band. The cap is printed in black with “RL33”and the body is printed in black with “RL33”.

Box of 30 capsules (3 x 10 Prescription Packs) NDC 10631-004-31

24 mg: A size 1, yellow, capsules banded with a colorless band. The cap is printed in white with “RL31” and the body is printed in white with “RL31”.

Box of 30 capsules (3 x 10 Prescription Packs) NDC 10631-005-31

28 mg: A size 0, light blue, capsules banded with a colorless band. The cap is printed in black with “RL34” and the body is printed in black with “RL34”.

Box of 30 capsules (3 x 10 Prescription Packs) NDC 10631-006-31

32 mg: A size 0, caramel, capsules banded with a colorless band. The cap is printed in white with “RL32” and the body is printed in white with “RL32”.

Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-007-31

Storage and Handling of ABSORICA and ABSORICA LD

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Protect from light.

9PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Embryo-Fetal Toxicity

There is an extremely high risk of life-threatening birth defects when ABSORICA/ABSORICA LD is used in pregnancy

iPLEDGE REMS

ABSORICA and ABSORICA LD are available only through a restricted program called the iPLEDGE REMS

Enroll in the REMS
Comply with REMS requirements including:

Inform patients who cannot get pregnant of the following notable requirements. These patients must enroll in the REMS and comply with the REMS requirements.

ABSORICA/ABSORICA LD is available only from certified pharmacies participating in the REMS. Therefore, provide patients with the telephone number and website for information on how to obtain ABSORICA/ABSORICA LD

Lactation

Because of the potential for serious adverse reactions in nursing infants from isotretinoin, advise patients that breastfeeding is not recommended during treatment with ABSORICA/ABSORICA LD, and for at least 8 days after the last dose of ABSORICA/ABSORICA LD

Psychiatric Disorders

Important Administration Instructions

To decrease the risk of esophageal irritation, instruct patients to swallow the capsules with a full glass of liquid

Intracranial Hypertension (Pseudotumor Cerebri)

Advise patients that intracranial hypertension (pseudotumor cerebri) has occurred with ABSORICA/ABSORICA LD use including concomitant use with tetracyclines. Thus, advise patients to avoid concomitant use with tetracyclines and to discontinue ABSORICA/ABSORICA LD immediately if they have symptoms of intracranial hypertension

Serious Skin Reactions

Advise patients that severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported in patients treated with isotretinoin and to discontinue ABSORICA/ABSORICA LD if clinically significant skin reactions occur

Inflammatory Bowel Disease

Advise patients that inflammatory bowel disease (including regional ileitis) have occurred with isotretinoin use including those without a prior history of IBD and if they experience IBD symptoms, to discontinue ABSORICA/ABSORICA LD immediately

Musculoskeletal Abnormalities

Inform patients that:

There have been reports of osteoporosis and fractures and that isotretinoin may have a negative effect on bone mineral density
Isotretinoin use has been associated with musculoskeletal abnormalities (e.g., arthralgia, back pain)

Inform pediatric patients and their families that isotretinoin use in pediatric patients who participated in sports with repetitive impact increased their risk of spondylolisthesis or hip growth plate injuries

Inform pediatric patients and their caregivers that pediatric patients treated with isotretinoin capsules developed back pain including severe back pain, and arthralgias including severe arthralgias

Ocular Abnormalities

Inform patients that they may experience dry eyes, corneal opacities, and decreased night vision and contact lens wearers may experience decreased tolerance to contact lenses during and after treatment

Rhabdomyolysis

Inform patients there have been rare postmarketing reports of rhabdomyolysis in patients treated with isotretinoin capsules, some associated with strenuous physical activity

Hypersensitivity Reactions

Given that anaphylactic reactions and other allergic reactions have been reported in patients treated with isotretinoin capsules, instruct the patient to discontinue ABSORICA/ABSORICA LD and contact their healthcare provider if they have a severe allergic reaction

Lipid Abnormalities

Instruct patients that hypertriglyceridemia, decreased HDL, and increased cholesterol levels were reported in patients treated with isotretinoin capsules

Additional Instructions

Inform patients:

To not share ABSORICA/ABSORICA LD with anyone else because of the risk of birth defects and other serious adverse reactions.
That transient exacerbation (flare) of acne has been seen, generally during the initial period of treatment.
To avoid wax epilation and skin resurfacing procedures (such as dermabrasion, laser) during ABSORICA/ABSORICA LD treatment and for at least 6 months thereafter due to the possibility of scarring.
To avoid prolonged exposure to UV rays or sunlight.

10Medication Guide

This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev:6/2026

11Absorica 10 mg Blister