Medical Editor: John P. Cunha, DO, FACOEP
What Is Absorica?
Absorica (isotretinoin) is a retinoid, a form of vitamin A, used to treat a severe form of acne called nodular acne in patients 12 years of age and older who have not been helped by other acne treatments, including antibiotics.
What Are Side Effects of Absorica?
Side effects of Absorica include:
- mental health problems (such as depression, psychosis, or thoughts of suicide),
- skin reactions such as infections or rash,
- dry skin,
- bone or joint pain,
- eye inflammation (dry eyes, burning, redness, itching),
- difficulty moving,
- dry nose that can lead to nosebleeds,
- inflammation of the lips (including chapping, scaling, redness, pain, burning), and
- abdominal pain
Contact your doctor immediately if you experience depression, thoughts of suicide, or psychosis while taking Absorica.
Dosage for Absorica
Absorica is taken orally. The recommended dosage of 0.5 to 1 mg/kg/day is given in two divided doses for 15 to 20 weeks. Absorica is not substitutable with other forms of isotretinoin.
What Drugs, Substances, or Supplements Interact with Absorica?
Absorica may interact with:
- vitamin supplements containing Vitamin A,
- St. John's Wort,
- systemic corticosteroids, and
- oral contraceptives
Tell your doctor all medications and supplements you use.
Absorica During Pregnancy and Breastfeeding
Female patients must not become pregnant for one month before starting Absorica; while taking Absorica, and/or for one month after stopping Absorica, since this medication can cause severe birth defects. It is not known whether this drug is present in human milk. Consult your doctor before breastfeeding.
Our Absorica Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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 [see WARNINGS AND PRECAUTIONS]
- Psychiatric Disorders [see WARNINGS AND PRECAUTIONS]
- Intracranial Hypertension (Pseudotumor Cerebri) [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Pancreatitis [see WARNINGS AND PRECAUTIONS]
- Lipid Abnormalities [see WARNINGS AND PRECAUTIONS]
- Hearing Impairment [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Inflammatory Bowel Disease [see WARNINGS AND PRECAUTIONS]
- Musculoskeletal Abnormalities [see WARNINGS AND PRECAUTIONS]
- Ocular Abnormalities [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
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.
Cheilitis and hypertriglyceridemia were dose related.
Body as a Whole
Fatigue, irritability, pain, allergic reactions, systemic hypersensitivity, edema, lymphadenopathy, weight loss.
Vascular thrombotic disease, stroke, palpitation, tachycardia.
Endocrine/Metabolism and Nutritional
Decreased appetite, weight fluctuation, alterations in blood sugar.
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.
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).
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], skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, tendonitis, arthritis, transient chest pain, and rare reports of rhabdomyolysis.
Headache, syncope, intracranial hypertension (pseudotumor cerebri), dizziness, drowsiness, lethargy, malaise, nervousness, paresthesia, seizures, stroke, weakness.
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.
Abnormal menses, sexual dysfunction, including erectile dysfunction and decreased libido.
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).
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
Read the entire FDA prescribing information for Absorica (Isotretinoin)