Isotretinoin Information
What is this drug used for?
• It is used to treat pimples (acne).
• It may be given to you for other reasons. Talk with the doctor.
Frequently reported side effects of this drug
• Dry mouth
• Dry eyes
• Dry skin
• Dry lips
• Nasal irritation
• Poor night vision
• Contact lens discomfort
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Severe cerebrovascular disease like change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or vision changes
• Depression like thoughts of suicide, anxiety, agitation, irritability, panic attacks, mood changes, behavioral changes, or confusion
• Infection
• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.
• Esophageal problems like chest pain, trouble swallowing, or heartburn.
• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit.
• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting.
• Seizures
• Behavioral changes
• Nausea
• Vomiting
• Severe headache
• Dizziness
• Severe diarrhea
• Rectal bleeding
• Rectal pain
• Severe abdominal pain
• Eye pain
• Muscle pain
• Muscle weakness
• Joint pain
• Bone pain
• Bruising
• Bleeding
• Severe loss of strength and energy
• Unable to pass urine
• Change in amount of urine passed
• Back pain
• Swelling
• Swollen gland
• Abnormal heartbeat
• Fast heartbeat
• Trouble hearing
• Noise or ringing in the ears
• Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes.
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Medication Safety Issues
Sound-alike/look-alike issues:
Accutane may be confused with Accolate, Accupril
Claravis may be confused with Cleviprex
ISOtretinoin may be confused with tretinoin
High alert medication:
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.
Other safety concerns:
Isotretinoin may be confused with tretinoin (which is also called all-trans retinoic acid, or ATRA); while both products may have uses in cancer treatment, they are not interchangeable.
Storage/Stability
Store at 20°C to 25°C (68°F to 77° F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light
Adverse Reactions
>10%:
Endocrine & metabolic: Increased serum triglycerides (25% including cases reported >800 mg/dL), increased creatine phosphokinase in blood specimen (adults: 24%; adolescents: 12%), decreased HDL cholesterol (15%)
Hepatic: Increased liver enzymes (15%)
Neuromuscular & skeletal: Back pain (children: 29%), arthralgia (≤22%), musculoskeletal disease (16%)
1% to 10%:
Endocrine & metabolic: Increased serum cholesterol (7%)
Neuromuscular & skeletal: Decreased bone mineral density (adolescents: 9%), severe arthralgia (children: 8%)
Frequency not defined:
Cardiovascular: Cerebrovascular accident, chest pain, edema, flushing, palpitations, syncope, tachycardia, thrombosis, vasculitis
Dermatologic: Acne fulminans, alopecia, cheilitis, cheilosis, contact dermatitis, dermatitis, diaphoresis, eczema, erythema of skin, facial erythema, fragile skin, hair disease, nail disease, paronychia, pruritus, pyogenic granuloma, scaling of skin of feet, seborrhea, skin photosensitivity, skin rash, sunburn, superficial peeling of palms, urticaria, xeroderma
Endocrine & metabolic: Altered serum glucose, decreased libido, eruptive xanthoma, hirsutism, increased gamma-glutamyl transferase, increased lactate dehydrogenase, increased LDL cholesterol, increased serum glucose, hyperuricemia, menstrual disease, weight loss
Gastrointestinal: Abdominal pain, colitis, constipation, decreased appetite, diarrhea, esophagitis, esophageal ulcer, gingival hemorrhage, gingivitis, ileitis, inflammatory bowel disease, nausea, pancreatitis, vomiting, xerostomia
Genitourinary: Erectile dysfunction, gross hematuria, microscopic hematuria, proteinuria, pyuria, sexual disorder
Hematologic & oncologic: Anemia, bruise, decreased white blood cell count, increased erythrocyte sedimentation rate, lymphadenopathy, purpuric disease, severe neutropenia, thrombocythemia, thrombocytopenia
Hepatic: Increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, increased serum bilirubin
Infection: Herpes simplex infection (disseminated), infection
Nervous system: Aggressive behavior, anxiety, auditory hallucinations, depression, dizziness, drowsiness, emotional lability, euphoria, fatigue, headache, idiopathic intracranial hypertension, insomnia, irritability, lethargy, malaise, nervousness, outbursts of anger, pain, panic attack, paresthesia, psychosis, seizure, suicidal ideation, suicidal tendencies, violent behavior, voice disorder
Neuromuscular & skeletal: Asthenia, arthritis, bone fracture, calcification of ligament, calcification of tendon, granulomatosis with polyangiitis, limb pain, musculoskeletal pain, myalgia, neck pain, osteopenia, osteoporosis, premature epiphyseal closure, skeletal hyperostosis, stiffness, tendonitis
Ophthalmic: Asthenopia, blepharitis, blurred vision, cataract, conjunctivitis, corneal opacity, decreased visual acuity, eye irritation, eye pruritus, hordeolum, increased lacrimation, keratitis, ocular hyperemia, optic neuritis, photophobia, vision color changes, visual disturbance
Otic: Tinnitus
Renal: Glomerulonephritis
Respiratory: Bronchospasm, dry nose, epistaxis, nasopharyngitis, respiratory tract infection, upper respiratory tract infection
Miscellaneous: Wound healing impairment
Postmarketing: Acute pancreatitis, agranulocytosis, allergic skin reaction, anaphylaxis, auditory impairment, dry eye syndrome, erythema multiforme, eyelid disease (meibomian gland dysfunction/atrophy; Neudorfer 2012), hepatitis, hypersensitivity angiitis, hypersensitivity reaction, intracranial hypertension (Tan 2019), night blindness, rhabdomyolysis, Stevens-Johnson syndrome, toxic epidermal necrolysis
