Isotretinoin — Membership Pricing

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What Isotretinoin is approved for (FDA label)

Isotretinoin Capsules is 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, Isotretinoin Capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.

Source: Read the full FDA label on DailyMed. Label effective date: August 27, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Isotretinoin (FDA label)

WARNING: EMBRYO-FETAL TOXICITY - CONTRAINDICATED IN PREGNANCY Isotretinoin Capsules 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 Isotretinoin Capsules 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 Isotretinoin Capsules immediately and refer the patient to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1)] . Because of the risk of embryo-fetal toxicity, Isotretinoin Capsules is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS [see Warnings and Precautions (5.2)]. WARNING: EMBRYO-FETAL TOXICITY - CONTRAINDICATED IN PREGNANCY See full prescribing information for complete boxed warning. Isotretinoin Capsules 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 Isotretinoin Capsules in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. (4, 5.1, 8.1) Isotretinoin Capsules are available only through a restricted program called the iPLEDGE REMS. (5.2)

Source: FDA prescribing information (DailyMed). Set ID: c2917c3d-3499-48a0-ba53-120cb979195d. SPL document ID: 9466bc95-3be7-43f8-b0c3-74a7df2d5a67. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Isotretinoin (FDA label)

Capsules: 10 mg: Oval, gray, soft gelatin capsules, printed with “A66”. 20 mg: Oval, brown, soft gelatin capsules, printed with “A67”. 30 mg: Oval, dark orange, soft gelatin capsules, printed with “A01”. 40 mg: Oval, orange, soft gelatin capsules, printed with “A68”. Capsules: 10 mg, 20 mg, 30mg and 40 mg (3)

Source: FDA prescribing information (DailyMed). Set ID: c2917c3d-3499-48a0-ba53-120cb979195d. SPL document ID: 9466bc95-3be7-43f8-b0c3-74a7df2d5a67. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Isotretinoin (FDA label)

The following adverse reactions with isotretinoin capsules are described in more detail in other sections of the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions (5.1)] Psychiatric Disorders [see Warnings and Precautions (5.3)] Intracranial Hypertension (Pseudotumor Cerebri) [see Warnings and Precautions (5.4)] Serious Skin Reactions [see Warnings and Precautions (5.5)] Pancreatitis [see Warnings and Precautions (5.6)] Lipid Abnormalities [see Warnings and Precautions (5.7)] Hearing Impairment [see Warnings and Precautions (5.8)] Hepatotoxicity [see Warnings and Precautions (5.9)] Inflammatory Bowel Disease [see Warnings and Precautions (5.10)] Musculoskeletal Abnormalities [see Warnings and Precautions (5.11)] Ocular Abnormalities [see Warnings and Precautions (5.12)] Hypersensitivity Reactions [see Warnings and Precautions (5.13)] The following adverse reactions, presented alphabetically by body system, associated with the use of isotretinoin capsules were identified in clinical studies or postmarketing reports.

Source: FDA prescribing information (DailyMed). Set ID: c2917c3d-3499-48a0-ba53-120cb979195d. SPL document ID: 9466bc95-3be7-43f8-b0c3-74a7df2d5a67. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Isotretinoin (FDA label)

Isotretinoin Capsules is contraindicated in: Pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . 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) [see Warnings and Precautions (5.14)] . Isotretinoin Capsules are contraindicated in: Pregnancy (4, 8.1) Patients with hypersensitivity to isotretinoin (or Vitamin A) or any of its components (4.2, 5.13)

Source: FDA prescribing information (DailyMed). Set ID: c2917c3d-3499-48a0-ba53-120cb979195d. SPL document ID: 9466bc95-3be7-43f8-b0c3-74a7df2d5a67. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Isotretinoin (FDA label)

Psychiatric Disorders (depression, psychosis, suicidal thoughts and behavior, and aggressive and/or violent behaviors): Prior to and during treatment assess for these conditions; stop if these conditions occur on treatment (5.3) Intracranial Hypertension (Pseudotumor Cerebri) : Avoid concomitant use with tetracyclines (5.4, 7.2) Serious Skin Reactions : Monitor for Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious skin reactions and discontinue treatment if they occur (5.5) Acute Pancreatitis : If pancreatitis symptoms occur, discontinue treatment (5.6) Lipid Abnormalities (hypertriglyceridemia, low HDL, and elevation of cholesterol): Monitor lipid levels at regular intervals; stop if hypertriglyceridemia cannot be controlled (5.7) Hearing Impairment : Discontinue and refer to specialized care (5.8) Hepatotoxicity : Monitor liver function tests prior to and during treatment (5.9, 5.14) Inflammatory Bowel Disease : Discontinue for abdominal pain, rectal bleeding, or severe diarrhea (5.10) Musculoskeletal Abnormalities : Arthralgias, back pain, decreases in bone mineral density and premature epiphyseal

Source: FDA prescribing information (DailyMed). Set ID: c2917c3d-3499-48a0-ba53-120cb979195d. SPL document ID: 9466bc95-3be7-43f8-b0c3-74a7df2d5a67. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Isotretinoin (FDA label)

Vitamin A : Avoid concomitant use (7.1) Tetracyclines : Avoid concomitant use (7.2) 7.1 Vitamin A Avoid concomitant use of Isotretinoin Capsules with supplements containing vitamin A. Isotretinoin Capsules are closely related to vitamin A. Therefore, concomitant use of Isotretinoin Capsules with vitamin A may lead to Isotretinoin Capsules-related adverse reactions. 7.2 Tetracyclines Avoid concomitant use of Isotretinoin Capsules with tetracyclines. Isotretinoin Capsules use has been associated with a number of cases of intracranial hypertension (pseudotumor cerebri), some of which involved concomitant use with tetracyclines [see Warnings and Precautions (5.4)]. 7.3 Oral Contraceptives It is not known if there is an interaction between Isotretinoin Capsules with oral contraceptives that do not contain norethindrone and ethinyl estradiol. Isotretinoin Capsules did not result in clinically significant changes in the pharmacokinetics of norethindrone and ethinyl estradiol when used concomitantly with norethindrone and ethinyl estradiol oral contraceptive [see Clinical Pharmacology (12.3)].

Source: FDA prescribing information (DailyMed). Set ID: c2917c3d-3499-48a0-ba53-120cb979195d. SPL document ID: 9466bc95-3be7-43f8-b0c3-74a7df2d5a67. Label effective date: August 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.