Accutane (Isotretinoin) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical Trials and PostmarketingSurveillance

The adverse reactions listed below reflect the experiencefrom investigational studies of Accutane, and the postmarketing experience.The relationship of some of these events to Accutane therapy is unknown.Many of the side effects and adverse reactions seen in patients receivingAccutane are similar to those described in patients taking very highdoses of vitamin A (dryness of the skin and mucous membranes, eg,of the lips, nasal passage, and eyes).

Dose Relationship

Cheilitis and hypertriglyceridemia are usually doserelated. Most adverse reactions reported in clinical trials were reversiblewhen therapy was discontinued; however, some persisted after cessationof therapy (see WARNINGS and ADVERSE REACTIONS).

Body as a Whole

allergic reactions, including vasculitis, systemichypersensitivity (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: InflammatoryBowel Disease), hepatitis (see WARNINGS: Hepatotoxicity), pancreatitis (see WARNINGS: Lipids), bleeding andinflammation of the gums, colitis, esophagitis/esophageal ulceration,ileitis, nausea, other nonspecific gastrointestinal symptoms

Hematologic

allergic reactions (see PRECAUTIONS: Hypersensitivity), anemia, thrombocytopenia, neutropenia, rare reportsof agranulocytosis (see PRECAUTIONS: Information for Patients). See PRECAUTIONS: Laboratory Tests for other hematological parameters.

Musculoskeletal

skeletal hyperostosis, calcification of tendons andligaments, premature epiphyseal closure, decreases in bone mineraldensity (see WARNINGS: Skeletal), musculoskeletal symptoms(sometimes severe) including back pain, myalgia, and arthralgia (see PRECAUTIONS: Informationfor Patients), transient pain in the chest (see PRECAUTIONS: Informationfor Patients), arthritis, tendonitis, other typesof 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 thepatients reporting depression, some reported that the depression subsidedwith discontinuation of therapy and recurred with reinstitution oftherapy.

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, hyperpigmentationand hypopigmentation, infections (including disseminated herpes simplex),nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizingreactions, 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 exuberantgranulation tissue with crusting; see PRECAUTIONS: Information for Patients)

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: DecreasedNight 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: LaboratoryTests 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)

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

Decreases in redblood cell parameters, decreases in white blood cell counts (includingsevere neutropenia and rare reports of agranulocytosis; see PRECAUTIONS: Informationfor Patients), elevated sedimentation rates,elevated platelet counts, thrombocytopenia

Whitecells in the urine, proteinuria, microscopic or gross hematuria

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ACCUTANE

Possible Accutane side effects / adverse reactions in 23 year old female

Reported by a lawyer from United States on 2007-01-09

Patient: 23 year old female weighing 55.8 kg (122.8 pounds)

Reactions: Colitis Ulcerative, Anaemia, Osteopenia, Intestinal Haemorrhage, Anxiety, Malaise, Anhedonia, Hepatotoxicity, Dehydration, Musculoskeletal Disorder, Colitis, Injury, Depression, Inflammatory Bowel Disease

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Accutane
    Dosage: indication reported as ane vulgaris and acne rosacea.
    Administration route: Oral
    Indication: Acne
    Start date: 1997-06-24
    End date: 1997-11-21

Accutane
    Dosage: indication reported as ane vulgaris and acne rosacea.
    Administration route: Oral
    Start date: 2001-01-10
    End date: 2001-06-08

Accutane
    Dosage: indication reported as ane vulgaris and acne rosacea.
    Administration route: Oral
    Start date: 2003-03-17
    End date: 2003-05-17

Other drugs received by patient: Oral Contraceptives NOS

Possible Accutane side effects / adverse reactions in 45 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-10

Patient: 45 year old male

Reactions: Malignant Neoplasm Progression, Brain Neoplasm

Suspect drug(s):
Accutane
    Indication: Drug USE FOR Unknown Indication

Amnesteem
    Indication: Drug USE FOR Unknown Indication

Possible Accutane side effects / adverse reactions in 15 year old male

Reported by a lawyer from United States on 2007-01-10

Patient: 15 year old male weighing 54.4 kg (119.7 pounds)

Reactions: Gastrointestinal Haemorrhage, Rectal Haemorrhage, Rheumatic Fever, Intentional Drug Misuse, Gastritis, Substance Abuse, Suicidal Ideation, Rheumatoid Arthritis, Ureteric Obstruction, Musculoskeletal Disorder, Ileitis, Injury, Depression, Tendonitis, Vomiting, Polyp, Nausea, Suicidal Behaviour, Anaemia, Crohn's Disease, Neck Injury, Intestinal Obstruction, Tendon Calcification, Ligament Calcification, Autoimmune Disorder, Panic Attack, Gastrointestinal Disorder, Suicide Attempt, Homicidal Ideation, Multi-Organ Disorder, Inflammatory Bowel Disease

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Accutane
    Indication: Acne
    Start date: 1996-10-03
    End date: 1996-11-15

Accutane
    Start date: 1996-11-15
    End date: 1997-08-18

Valium
    Indication: Drug USE FOR Unknown Indication
    Start date: 2004-10-03
    End date: 2004-10-03