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Sotret

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Sotret

Sotret

Sotret Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Sotret (isotretinoin) is a form of Vitamin A used to treat severe nodular acne that has not responded to other treatments, including antibiotics. This medication is available in generic form. Common side effects include joint pain, back pain, dizziness, drowsiness, nervousness, dryness of the lips, mouth, nose, or skin, or cracking or peeling skin, itching, rash, and changes in your fingernails or toenails.

The recommended dosage range for Sotret is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. Sotret may interact with steroids, seizure medications, or antibiotics. Tell your doctor all medications and supplements you use. Do not use Sotret if you are pregnant or may become pregnant. Sotret causes birth defects. Sotret is available only under a special program called iPLEDGE. You must be registered in the program and sign documents stating you understand the dangers of this medication and you agree to use birth control as required by the program. You must have a negative pregnancy test 30 days before you start taking this drug. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of Sotret, and again 30 days later. Consult your doctor for details on iPLEDGE. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Sotret (isotretinoin) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Sotret in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these 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 any of these serious side effects:

  • depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
  • sudden numbness or weakness, especially on one side of the body;
  • blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
  • hearing problems, hearing loss, or ringing in your ears;
  • seizure (convulsions);
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
  • fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding;
  • severe blistering, peeling, and red skin rash; or
  • joint stiffness, bone pain or fracture.

Less serious side effects may include:

  • joint pain, back pain;
  • feeling dizzy, drowsy, or nervous;
  • dryness of the lips, mouth, nose, or skin; or
  • cracking or peeling skin, itching, rash, changes in your fingernails or toenails.

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.

Read the entire detailed patient monograph for Sotret (Isotretinoin Capsules) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sotret FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials and Postmarketing Surveillance

The adverse reactions listed below reflect the experience from investigational studies of isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin capsules, and the postmarketing experience. The relationship of some of these events to isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin capsules therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin capsules 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 usually dose related. Most adverse reactions reported in clinical trials were reversible when therapy was discontinued; however, some persisted after cessation of therapy (see WARNINGS and ADVERSE REACTIONS).

Body as a Whole

allergic reactions, including vasculitis, systemic hypersensitivity (see PRECAUTIONS: Hypersensitivity), edema, fatigue, lymphadenopathy, weight loss

Cardiovascular

palpitation, tachycardia, vascular thrombotic disease, stroke

Endocrine/Metabolic

hypertriglyceridemia (see WARNINGS: Lipids), alterations in blood sugar levels (see PRECAUTIONS: Laboratory Tests)

Gastrointestinal

inflammatory bowel disease (see WARNINGS: Inflammatory Bowel Disease), hepatitis (see WARNINGS: Hepatotoxicity), pancreatitis (see WARNINGS: Lipids), bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, other nonspecific gastrointestinal symptoms

Hematologic

allergic reactions (see PRECAUTIONS: Hypersensitivity), anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis (see PATIENT INFORMATION). See PRECAUTIONS: Laboratory Tests for other hematological parameters.

Musculoskeletal

skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, decreases in bone mineral density (see WARNINGS: Skeletal), musculoskeletal symptoms (sometimes severe) including back pain, myalgia, and arthralgia (see PATIENT INFORMATION), transient pain in the chest (see PATIENT INFORMATION), arthritis, tendonitis, other types of bone abnormalities, elevations of CPK/rare reports of rhabdomyolysis (see PRECAUTIONS: Laboratory Tests).

Neurological

pseudotumor cerebri (see WARNINGS: Pseudotumor Cerebri), dizziness, drowsiness, headache, insomnia, lethargy, malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness

Psychiatric

suicidal ideation, suicide attempts, suicide, depression, psychosis, aggression, violent behaviors (see WARNINGS: Psychiatric Disorders), emotional instability 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

Respiratory

bronchospasms (with or without a history of asthma), respiratory infection, voice alteration

Skin and Appendages

acne fulminans, alopecia (which in some cases persists), bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive xanthomas,7 flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), sunburn susceptibility increased, sweating, urticaria, vasculitis (including Wegener's granulomatosis; see PRECAUTIONS: Hypersensitivity), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting; see PATIENT INFORMATION)

Special Senses

Hearing

hearing impairment (see WARNINGS: Hearing Impairment), tinnitus.

Vision

corneal opacities (see WARNINGS: Corneal Opacities), decreased night vision which may persist (see WARNINGS: Decreased Night Vision), cataracts, color vision disorder, conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual disturbances

Urinary System

glomerulonephritis (see PRECAUTIONS: Hypersensitivity), nonspecific urogenital findings (see PRECAUTIONS: Laboratory Tests for other urological parameters)

Laboratory

Elevation of plasma triglycerides (see WARNINGS: Lipids), decrease in serum high-density lipoprotein (HDL) levels, elevations of serum cholesterol during treatment

Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH (see WARNINGS: Hepatotoxicity)

Elevation of fasting blood sugar, elevations of CPK (see PRECAUTIONS: Laboratory Tests), hyperuricemia

Decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis; see PATIENT INFORMATION), elevated sedimentation rates, elevated platelet counts, thrombocytopenia

White cells in the urine, proteinuria, microscopic or gross hematuria

Read the entire FDA prescribing information for Sotret (Isotretinoin Capsules) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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