Absorica

Name: Absorica

How should I take Absorica (isotretinoin)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Each prescription of isotretinoin must be filled within 7 days of the date it was written by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time.

Always take isotretinoin with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.

Take isotretinoin with food.

Use this medicine for the full prescribed length of time. Your acne may seem to get worse at first, but should then begin to improve.

While using isotretinoin, you may need frequent blood tests.

Never share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling in your face, swollen or cracked lips, and loss of balance or coordination.

Absorica (isotretinoin) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using isotretinoin and call your doctor at once if you have:

  • problems with your vision or hearing;

  • severe headache, dizziness, seizure (convulsions), sudden numbness or weakness;

  • depressed mood, sleep problems, crying spells, changes in behavior, feeling aggressive or irritable;

  • hallucinations, (see or hearing things that are not real), thoughts about suicide or hurting yourself;

  • muscle weakness, pain in your bones or joints or in your back;

  • severe diarrhea, rectal bleeding, bloody or tarry stools;

  • pale skin, feeling light-headed or short of breath;

  • dark urine, or jaundice (yellowing of your skin or eyes);

  • severe stomach or chest pain, pain when swallowing; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • dryness of your skin, lips, eyes, or nose (you may have nosebleeds).

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.

What other drugs will affect Absorica (isotretinoin)?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • vitamin or mineral supplements;

  • St. John's wort; or

  • a tetracycline antibiotic, including doxycycline or minocycline.

This list is not complete. Other drugs may interact with isotretinoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What are some things I need to know or do while I take Absorica?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Absorica (isotretinoin) affects you.
  • Do not donate blood while using this medicine and for 1 month after stopping.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
  • If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
  • Check your blood sugar as you have been told by your doctor.
  • Skin may look worse before it looks better.
  • Talk with your doctor before you drink alcohol.
  • If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
  • Avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments during your care and for at least 6 months after care has ended. The chance of scarring may be raised.
  • This medicine may cause weak bones and tendon problems in some people. The chance of bone problems like broken bones may be raised in people who play certain sports. Talk with the doctor.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • Lowered night eyesight may happen. Use care at night when driving or doing other tasks that call for clear eyesight. Keep work space well lit.
  • Raised pressure in the brain has happened with Absorica. This can cause long lasting loss of eyesight and sometimes death. Call your doctor right away if you have a bad headache, dizziness, upset stomach or throwing up, or seizures. Call your doctor right away if you have weakness on 1 side of the body, trouble speaking or thinking, change in balance, or change in eyesight.
  • Very bad bowel problems may happen with this medicine (inflammatory bowel disease). Tell your doctor right away if you have signs like very bad loose stools (diarrhea), belly pain, bleeding from the rectum, or rectal pain. This may clear up after you stop the drug but sometimes it may not go away.
  • This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Do not use progestin-only birth control pills (minipills). They may not work well. Talk with your doctor.
  • If you have sex without using 2 kinds of birth control that you can trust, if you think you may be pregnant, or if you miss your period, call your doctor right away.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • Mean actions or thoughts of fighting.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of esophagus problems like chest pain, trouble swallowing, or new or worse heartburn.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Eye pain.
  • Muscle pain or weakness.
  • Bone or joint pain.
  • Any unexplained bruising or bleeding.
  • Feeling very tired or weak.
  • Not able to pass urine or change in how much urine is passed.
  • Back pain.
  • Hearing problems like change in hearing or ringing in the ears may happen. This may go away after stopping the drug but sometimes it may not.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Very bad and sometimes deadly pancreas problems (pancreatitis) have happened with Absorica. Call your doctor right away if you have very bad stomach pain, very bad back pain, or very upset stomach or throwing up.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Absorica, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Absorica. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Absorica (isotretinoin).

Review Date: October 4, 2017

Nonclinical Toxicology

Carcinogenesis, Mutagenesis and Impairment of Fertility

In male and female Fischer 344 rats given oral isotretinoin at dosages of 8 or 32 mg/kg/day (1.3 to 5.3 times the recommended clinical dose of 1 mg/kg/day, respectively, after normalization for total body surface area) for greater than 18 months, there was a dose-related increased incidence of pheochromocytoma relative to controls. The incidence of adrenal medullary hyperplasia was also increased at the higher dosage in both sexes. The relatively high level of spontaneous pheochromocytomas occurring in the male Fischer 344 rat makes it an equivocal model for study of this tumor; therefore, the relevance of this tumor to the human population is uncertain.

The Ames test was conducted with isotretinoin in two laboratories. The results of the tests in one laboratory were negative while in the second laboratory a weakly positive response (less than 1.6 x background) was noted in S. typhimurium TA100 when the assay was conducted with metabolic activation. No dose response effect was seen and all other strains were negative. Additionally, other tests designed to assess genotoxicity (Chinese hamster cell assay, mouse micronucleus test, S. cerevisiae D7 assay, in vitro clastogenesis assay with human-derived lymphocytes, and unscheduled DNA synthesis assay) were all negative.

In rats, no adverse effects on gonadal function, fertility, conception rate, gestation or parturition were observed at oral dosages of isotretinoin of 2, 8, or 32 mg/kg/day (0.3, 1.3, or 5.3 times the recommended clinical dose of 1 mg/kg/day, respectively, after normalization for total body surface area).

In dogs, testicular atrophy was noted after treatment with oral isotretinoin for approximately 30 weeks at dosages of 20 or 60 mg/kg/day (10 or 30 times the recommended clinical dose of 1 mg/kg/day, respectively, after normalization for total body surface area). In general, there was microscopic evidence for appreciable depression of spermatogenesis but some sperm were observed in all testes examined and in no instance were completely atrophic tubules seen.

In trials of 66 men, 30 of whom were patients with nodular acne under treatment with oral isotretinoin, no significant changes were noted in the count or motility of spermatozoa in the ejaculate. In a study of 50 men (ages 17 to 32 years) receiving isotretinoin therapy for nodular acne, no significant effects were seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose.

Animal Toxicology

In rats given 8 or 32 mg/kg/day of isotretinoin (1.3 to 5.3 times the recommended clinical dose of 1 mg/kg/day after normalization for total body surface area) for 18 months or longer, the incidences of focal calcification, fibrosis and inflammation of the myocardium, calcification of coronary, pulmonary and mesenteric arteries, and metastatic calcification of the gastric mucosa were greater than in control rats of similar age. Focal endocardial and myocardial calcifications associated with calcification of the coronary arteries were observed in two dogs after approximately 6 to 7 months of treatment with isotretinoin at a dosage of 60 to 120 mg/kg/day (30 to 60 times the recommended clinical dose of 1 mg/kg/day, respectively, after normalization for total body surface area).

Why is this medication prescribed?

Isotretinoin is used to treat severe recalcitrant nodular acne (a certain type of severe acne) that has not been helped by other treatments, such as antibiotics. Isotretinoin is in a class of medications called retinoids. It works by slowing the production of certain natural substances that can cause acne.

Description

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, FD&C Yellow #6 and titanium dioxide;
  • 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.

Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is:

Meets USP Dissolution Test 3

Absorica Overview

Absorica is a prescription medication used to treat the most severe form of acne called nodular acne. Absorica belongs to a group of drugs called retinoids. It is thought to work by preventing oil production in glands under the skin.

This medication comes in capsule form and is usually taken twice daily, with or without food. Absorica may be taken for four or five months. A longer periods of use is not recommended.

Common side effects of Absorica include dry skin, chapped lips, dry eyes, back pain, or dry nose causing nosebleeds. Absorica can also cause birth defects, miscarriages, or premature births.

Because Absorica can cause birth defects, patients, doctors, and pharmacies must be registered with a special distribution program called the iPLEDGE program.

Uses of Absorica

Absorica is a prescription medication used to treat severe from of acne (nodular acne) that has not responded to other treatments.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Absorica Usage

Take Absorica exactly as prescribed. You must also follow all the instructions of the iPLEDGE program. Before prescribing Absorica, your doctor will:

  • explain the iPLEDGE program to you
  • have you sign the Patient Information/Informed Consent form (for all patients). Female patients who can get pregnant must also sign another consent form.

You will not be prescribed Absorica if you cannot agree to or follow all the instructions of the iPLEDGE program.

  • You will get no more than a 30 day supply of Absorica at a time. This is to make sure you are following the iPLEDGE program. You should talk with your doctor each month about side effects.
  • The amount of Absorica you take has been specially chosen for you. It is based on your body weight, and may change during treatment.
  • Take Absorica 2 times a day with or without food, unless your doctor tells you otherwise. Swallow your Absorica capsules whole with a full glass of liquid. Do not chew or suck on the capsule. Absorica can hurt the tube that connects your mouth to your stomach (esophagus) if it is not swallowed whole.
  • If you miss a dose, just skip that dose. Do not take two doses at the same time.
  • If you take too much Absorica or overdose, call your doctor or poison control center right away.
  • Your acne may get worse when you first start taking Absorica. This should last only a short while. Talk with your doctor if this is a problem for you.
  • You must return to your doctor as directed to make sure you don’t have signs of serious side effects. Your doctor may do blood tests to check for serious side effects from Absorica. Female patients who can get pregnant will get a pregnancy test each month.
  • Female patients who can get pregnant must agree to use two separate forms of effective birth control at the same time one month before, while taking and for one month after taking Absorica. You must access the iPLEDGE system to answer questions about the program requirements and to enter your two chosen forms of birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com or call 1-866-495-0654.

You must talk about effective birth control methods with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Absorica.

If you have sex at any time without using two forms of effective birth control, get pregnant or miss your expected period, stop using Absorica and call your doctor right away.

What you should avoid while taking Absorica:

  • Do not get pregnant while taking Absorica and for one month after stopping Absorica. See “Absorica Precautions" section.
  • Do not breastfeed while taking isotretinoin and for one month after stopping Absorica. It is not known if Absorica can pass through your milk and harm the baby.
  • Do not give blood while you take Absorica and for one month after stopping Absorica. If someone who is pregnant gets your donated blood, her baby may be exposed to Absorica and may be born with birth defects.
  • Do not take other medicines or herbal products with Absorica unless you talk to your doctor.
  • Do not drive at night until you know if Absorica has affected your vision. Absorica may decrease your ability to see in the dark.
  • Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Absorica and for at least 6 months after you stop. Absorica can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
  • Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Absorica may make your skin more sensitive to light.
  • Do not share Absorica with other people. It can cause birth defects and other serious health problems.

Absorica Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on your weight.

The recommended dosage range for Absorica (isotretinoin) is 0.5 to 1 mg/kg/day given in two divided doses.

Some patients may require dose adjustments up to 2 mg/kg/day.

Adverse Effects

>10%

Cheilitis (90%)

Xerosis

Xerostomia

Dry nose

Epistaxis

Pruritus

Conjunctivitis (including blepharoconjunctivitis) (40%)

Irritation (40%)

Increased erythrocyte sedimentation rates (40%)

Thinning of hair (which has persisted in rare instances)

Palmoplantar desquamation

Skin fragility

Skin infections (eg, paronychial infections)

Rash (including erythema, seborrhea, eczema), photosensitivity

Hypertriglyceridemia (25%)

Bone or joint pain

Generalized muscle aches

Arthralgia

Decreased HDLs (15%)

Increased LFTs (15%)

Increased CPK (12-24%)

Decreased hemoglobin concentration and hematocrit

Decreased erythrocyte and leukocyte counts

Increased platelet count

1-10%

Decreased bone mineral density (8.8%)

Premature epiphyseal closure (3%)

Frequency Not Defined

Lethargy

Fatigue

Headache

Anorexia

Nausea

Vomiting

Increased appetite

Thirst

Side effects

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

  • Embryofetal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Psychiatric Disorders [see WARNINGS AND PRECAUTIONS]
  • 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]
  • Skeletal Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Ocular Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of ABSORICA cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.

The adverse reactions listed below reflect both clinical experience with ABSORICA, and consider other adverse reactions that are known from clinical trials and the post-marketing surveillance with oral isotretinoin. The relationship of some of these events to isotretinoin therapy is unknown. Many of the side effects and adverse events seen in patients receiving isotretinoin are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g., of the lips, nasal passage, and eyes).

Dose Relationship

Cheilitis and hypertriglyceridemia are adverse reactions that are usually dose related. Most adverse reactions reported in clinical trials with isotretinoin were reversible when therapy was discontinued; however, some persisted after cessation of therapy.

Body as a Whole

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): fatigue, irritability, pain. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: allergic reactions, including vasculitis, systemic hypersensitivity, edema, lymphadenopathy, weight loss.

Cardiovascular

The following adverse reactions have been reported with isotretinoin: vascular thrombotic disease, stroke, palpitation, tachycardia.

Endocrine/Metabolism and Nutritional

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): decreased appetite, weight fluctuation, hyperlipidaemia. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: hypertriglyceridemia, alterations in blood sugar.

Gastrointestinal

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): lip dry, chapped lips, cheilitis, nausea, constipation, diarrhea, abdominal pain, vomiting. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: inflammatory bowel disease, hepatitis, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, and other nonspecific gastrointestinal symptoms.

Hematologic

The following adverse reactions have been reported with isotretinoin: allergic reactions, anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis.

Infections and infestations

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): nasopharyngitis, hordeolum, upper respiratory tract infection. In addition to the above adverse reactions, the following adverse reaction has been reported with isotretinoin: infections (including disseminated herpes simplex).

Laboratory Abnormalities

The following changes in laboratory tests have been noted in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): blood creatine phosphokinase (CPK) increased, blood triglycerides increased, alanine aminotransferase (SGPT) increased, aspartate aminotransferase (SGOT) increased, gamma-glutamyltransferase (GGTP) increased, blood cholesterol increased, low density lipoprotein (LDL) increased, white blood cell count decreased, blood alkaline phosphatase increased, blood bilirubin increased, blood glucose increased, high density lipopoprotein (HDL) decreased, bone mineral density decreased. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: increased LDH, elevation of fasting blood sugar, hyperuricemia, decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis), elevated sedimentation rates, elevated platelet counts, thrombocytopenia, white cells in the urine, proteinuria, microscopic or gross hematuria.

Musculoskeletal and Connective Tissue

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): decreases in bone mineral density, musculoskeletal symptoms (sometimes severe) including back pain, athralgia, musculoskeletal discomfort, musculoskeletal pain, neck pain, pain in extremity, myalgia, musculoskeletal stiffness [see WARNINGS AND PRECAUTIONS]. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, tendonitis, arthritis, transient pain in the chest, and rare reports of rhabdomyolysis.

Neurological

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): headache, syncope. In addition to the above adverse reactions, other adverse reactions reported with isotretinoin include: pseudotumor cerebri, dizziness, drowsiness, lethargy, malaise, nervousness, paresthesias, seizures, stroke, weakness.

Psychiatric

The following adverse reactions have been reported in clinical trials conducted with ABSORICA and a generic product of Accutane® (isotretinoin): suicidal ideation, insomnia, anxiety, depression, irritability, panic attack, anger, euphoria, violent behaviors, emotional instability. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: suicide attempts, suicide, aggression, psychosis and hallucination auditory. Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.

Reproductive System

The following adverse reaction has been reported with isotretinoin: abnormal menses.

Respiratory

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): epistaxis, nasal dryness. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: bronchospasms (with or without a history of asthma), respiratory infection, voice alteration.

Skin and Subcutaneous Tissue

The following adverse reactions have been reported in a clinical trial conducted with ABSORICA and a generic product of Accutane® (isotretinoin): dry skin, dermatitis, eczema, rash, dermatitis contact, alopecia, pruritus, sunburn, erythema. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: acne fulminans, alopecia (which in some cases persists), bruising, dry nose, eruptive xanthomas, erythema multiforme, flushing, fragility of skin, 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, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener's granulomatosis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting).

Special Senses

Hearing: The following adverse reactions have been reported with isotretinoin: tinnitus and hearing impairment.

Ocular: The following adverse reactions have been reported in clinical trials conducted with ABSORICA and a generic product of Accutane® (isotretinoin): dry eye, visual acuity reduced, vision blurred, eye pruritis, eye irritation, asthenopia, decreased night vision, ocular hyperemia, increased lacrimation, and conjunctivitis. In addition to the above adverse reactions, the following adverse reactions have been reported with isotretinoin: corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, eyelid inflammation, keratitis, optic neuritis, photobia, visual disturbances.

Renal and Urinary

The following adverse reactions have been reported in clinical trials conducted with isotretinoin: glomerulonephritis, nonspecific urogenital findings.

Read the entire FDA prescribing information for Absorica (Isotretinoin)

Read More »
(web3)