Retinoid

Isotretinoin

Approved 22 May 2025OralCapsule

The FDA lists this product in 36 strengths and forms.

Indications

Isotretinoin capsules 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, isotretinoin capsules 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 isotretinoin capsules 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 week to 20 week course of therapy [see Dosage and Administration ( 2.2 )]. Isotretinoin capsules are retinoids 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 are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. ( 1 ) Limitations of Use: If a second course of isotretinoin capsules 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 week to 20 week course of therapy.

( 1 )

Contraindications

Pregnancy ( 4.1 , 8.1 ) Hypersensitivity to this product or any of its components ( 4.2 , 5.14 )

4.1Pregnancy

Isotretinoin is contraindicated in pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].

4.2Hypersensitivity

Isotretinoin is contraindicated in 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 )].

Warnings and precautions

Psychiatric Disorders (depression, psychosis, suicidal thoughts and behavior and aggressive and/or violent behaviors): Prior to and during therapy assess for these conditions; stop if these conditions occur on therapy ( 5.4 ) Intracranial Hypertension (Pseudotumor Cerebri): Avoid use with concomitant tetracyclines ( 5.5 ) Serious Skin Reactions: Monitor for Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and other serious skin reactions ( 5.6 ) Acute Pancreatitis: If occurs, discontinue treatment ( 5.7 ) Lipid Abnormalities (hypertriglyceridemia, low HDL and elevation of cholesterol): Monitor lipid levels at regular intervals; stop if hypertriglyceridemia cannot be controlled ( 5.8 ) Hearing Impairment: Discontinue and refer to specialized care ( 5.9 ) Hepatotoxicity: Monitor liver function tests prior to and during therapy ( 5.10 , 5.15 ) Inflammatory Bowel Disease: Discontinue for abdominal pain, rectal bleeding or severe diarrhea ( 5.11 ) Musculoskeletal Abnormalities: Arthralgias, back pain, decreases in bone mineral density and premature epiphyseal closure ( 5.12 ) Ocular Abnormalities e.g., corneal opacities, decreased night vision: If visual symptoms occur, discontinue and refer for an ophthalmological exam ( 5.13 )

At a glance

Brand name: Isotretinoin
Pharmacologic class: Retinoid
Route: Oral
Dosage form: Capsule
Applicant: Zydus Pharms
Status: Prescription
FDA approval: 22 May 2025
Application: ANDA216633-004

Indications

( 1 )

Contraindications

Pregnancy ( 4.1 , 8.1 ) Hypersensitivity to this product or any of its components ( 4.2 , 5.14 )

4.1Pregnancy

Isotretinoin is contraindicated in pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].

4.2Hypersensitivity

Warnings and precautions

Pregnancy and breastfeeding

4.1Pregnancy

Isotretinoin is contraindicated in pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].

8.1Pregnancy Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to isotretinoin during pregnancy. Report any suspected fetal exposure during or 1 month after isotretinoin therapy immediately to the FDA via the MedWatch telephone number 1-800-FDA-1088 and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet (www.ipledgeprogram.com). Risk Summary Isotretinoin is contraindicated during pregnancy because isotretinoin can cause fetal harm when administered to a pregnant patient.

There is an increased risk of major congenital malformations, spontaneous abortions and premature births following isotretinoin exposure during pregnancy in humans. If isotretinoin is used during pregnancy or if the patient becomes pregnant while taking isotretinoin, the patient should be apprised of the potential hazard to a fetus. If pregnancy occurs during treatment of a patient who is taking isotretinoin, isotretinoin must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Data Human Data Major congenital malformations that have been documented following isotretinoin exposure include malformations of the face, eyes, ears, skull, central nervous system, cardiovascular system and thymus and parathyroid glands. External malformations include: skull; ear (including anotia, micropinna, small or absent external auditory canals); eye (including microphthalmia); facial dysmorphia and cleft palate.

Internal abnormalities include: CNS (including cerebral and cerebellar malformations, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular; thymus gland; parathyroid hormone deficiency. In some cases, death has occurred as a result of the malformations. Cases of IQ scores less than 85 with or without other abnormalities have been reported in children exposed in utero to isotretinoin. An increased risk of spontaneous abortion and premature births have been reported with isotretinoin exposure during pregnancy.

Adverse reactions

The following adverse reactions with isotretinoin or other isotretinoin capsule products 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 ( 5.4 )] Intracranial Hypertension (Pseudotumor Cerebri) [see Warnings and Precautions ( 5.5 )] Serious Skin Reactions [see Warnings and Precautions ( 5.6 )] Pancreatitis [see Warnings and Precautions ( 5.7 )] Lipid Abnormalities [see Warnings and Precautions ( 5.8 )] Hearing Impairment [see Warnings and Precautions ( 5.9 )] Hepatotoxicity [see Warnings and Precautions ( 5.10 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.11 )] Musculoskeletal Abnormalities [see Warnings and Precautions ( 5.12 )] Ocular Abnormalities [see Warnings and Precautions ( 5.13 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.14 )] The following adverse reactions associated with the use of isotretinoin capsules were identified in clinical studies 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 [see Warnings and Precautions ( 5.12 )] , skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, tendonitis, arthritis, transient chest pain and rare reports of rhabdomyolysis.

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, euphoria, 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 therapy and recurred with reinstitution of therapy.

Reproductive System Abnormal menses and 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.

Most common adverse reactions (incidence ≥ 5%) are: dry lips, dry skin, back pain, dry eye, arthralgia, epistaxis, headache, nasopharyngitis, chapped lips, dermatitis, increased creatine kinase, cheilitis, musculoskeletal discomfort, upper respiratory tract infection, reduced visual acuity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1- 877-993-8779 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or iPLEDGE at (1-866-495-0654).

Isotretinoin

Indications

Contraindications

4.1Pregnancy

4.2Hypersensitivity

Warnings and precautions

At a glance

Two medicines in one question?

Isotretinoin

Indications

Contraindications

4.1Pregnancy

4.2Hypersensitivity

Warnings and precautions

At a glance

Two medicines in one question?

5.1Embryo-Fetal Toxicity

5.3Isotretinoin and ABSORICA

5.4Psychiatric Disorders

5.5Intracranial Hypertension (Pseudotumor Cerebri)

5.6Serious Skin Reactions

5.7Pancreatitis

5.8Lipid Abnormalities Elevations

Interactions

7.2Tetracyclines

7.3Phenytoin

7.4Systemic Corticosteroids

Pregnancy and breastfeeding

4.1Pregnancy

8.1Pregnancy Pregnancy Exposure Registry

Adverse reactions

Composition

Strengths and forms

Official product information