Accutane Side Effects

Accutane Information

Accutane Side Effects

Clinical Trials and Postmarketing Surveillance

The Accutane side effects listed below reflect the experience from 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 receiving Accutane are similar to those described in patients taking very high doses 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 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 SIDE EFFECTS).

Body as a Whole

allergic reactions, including vasculitis, systemic hypersensitivity, edema, fatigue, lymphadenopathy, weight loss

Cardiovascular

palpitation
tachycardia
vascular thrombotic disease
stroke

Endocrine/Metabolic

hypertriglyceridemia
alterations in blood sugar levels

Gastrointestinal

inflammatory bowel disease
hepatitis
pancreatitis, -bleeding and inflammation of the gums
colitis
esophagitis/esophageal ulceration
ileitis
nausea
other nonspecific gastrointestinal symptoms

Hematologic

allergic reactions
anemia
thrombocytopenia
neutropenia
rare reports of agranulocytosis

Musculoskeletal

skeletal hyperostosis
calcification of tendons and ligaments
premature epiphyseal closure
decreases in bone mineral density
musculoskeletal symptoms (sometimes severe) including back pain and arthralgia
transient pain in the chest
arthritis
tendonitis
other types of bone abnormalities
elevations of CPK/rare reports of rhabdomyolysis

Neurological

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
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
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)
abnormal wound healing (delayed healing or exuberant granulation tissue with crusting)

Special Senses: Hearing

hearing impairment, tinnitus.

Special Senses: Vision

corneal opacities
decreased night vision which may persist
cataracts
olor vision disorder
conjunctivitis
dry eyes
eyelid inflammation
keratitis
optic neuritis
photophobia
visual disturbances

Urinary System

glomerulonephritis
nonspecific urogenital findings

Laboratory

Elevation of plasma triglycerides
decrease in serum high-density lipoprotein (HDL) levels
elevations of serum cholesterol during treatment
Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH
Elevation of fasting blood sugar, elevations of CPK
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