Accutane / Roaccutane - Isotretinoin

Accutane side effects

Accutane side effects are numerous and widespread, and affect upwards of 80% of patients.1 Side effects are most often mild to moderate and reversible, but in rare cases can be severe or long-term. When data exists, incidence information is listed. Hover your mouse over each potential side effect for more info.

Birth defects on Accutane

Accutane is the #1 prescribed teratogenic (causes birth defects) medication in the United States.2

The birth defects caused by Accutane are devastating and life threatening. Birth defects include skull, ear, eye, facial, central nervous system, cardiovascular, thymus, and parathyroid abnormalities, and also death.3 Clinical research shows extremely high risk for birth defects in pregnant women.4 The effects and risks of Accutane on unborn children are so severe that female patients of childbearing age are required to use two (2) forms of birth control while on Accutane.5

The iPLEDGE program was started in March 2006 to prevent women from becoming pregnant while on Accutane.5-6

iPLEDGE program telephone: 1-866-495-0654
iPLEDGE program website: ipledgeprogram.com

Hair loss
A small percentage of people are affected on a short-term basis and at a low level.7-8
Pressure within the skull
AKA intracranial hypertension. Clinical research found this to occur very rarely.8
Neurological symptoms
Including dizziness, drowsiness, insomnia, lethargy, malaise, nervousness, tingling/pricking/numbness (paresthesias), seizures, stroke, fainting (syncope), and weakness. Clinical research found this to occur in 16-29% of cases.8
Vision problems

Certain: abnormal oil secretion in the eye (abnormal meibomian gland secretion), inflamed mucus membrane that lines the eye (blepharoconjunctivitis), cornea becomes less transparent (corneal opacities), loss of night vision (decreased dark adaptation), decreased tolerance to contact lenses, decreased vision, increased salt concentration in tears (increased tear osmolarity), inflamed cornea (keratitis), oil gland atrophy in the eye (meibomian gland atrophy), near- or shortsightedness (myopia), eye discomfort (ocular discomfort), dry eye (ocular sicca), excessive sensitivity to light (photophobia), birth defects regarding the eyes (teratogenic ocular abnormalities).7,8

Probable/likely: decreased color vision [reversible], permanent loss of night vision AKA loss of dark adaptation.3,9

Possible: permanent dry eyes AKA keratoconjunctivitis sicca.7-8

As a side note, the FAA {United States Federal Aviation Administration} is considering more stringent rules regarding pilots who have been exposed to Accutane.9

Nosebleed
AKA Epistaxis. Clinical research found excessively dry nose to occur in 30% of cases.8
Hair overgrowth in women
Rare cases of hirsutism have been reported.
Severe allergy
Rare anaphylactic reactions have been reported in clinical research.8
Inflammation of the lips
Cheilitis.8
Bleeding & inflammation
 of the gums
Rash (including eczema)
Eczema is a medical condition in which patches of skin become rough and inflamed, with blisters that cause itching and bleeding. Clinical research has shown it may be exacerbated by Accutane use.7-8 Other, more rare forms of facial rash have been reported.10
Hives
AKA Uticaria. Rare cases of allergic reaction to Accutane, including hives, have been reported.7-8
Nail abnormalities
Extremeley rare cases of nail abnormalities have been reported.
Rapid breakdown of
 muscle tissue
AKA Rhabdomyolysis. Clinical research found this to occur in rare cases.8
Overgrowth of bone
AKA hyperostosis. Clinical research found detectable changes to occur in 10% of cases.8,11
Bone, tendon, and ligament calcification
Calcification is hardening of the bone, tendon, or ligament caused by the deposition of or conversion into calcium carbonate or some other insoluble calcium compounds; calcified cartilage.11 Clinical research found this to occur only in high-dose, long-term (several years) Accutane therapy.12
Joint pain
AKA Arthralgia. Clinical research found this to occur in 15% to 35% of cases.7-8,13-16
Acute, long lasting arthritis
Clinical research found this to occur extremely rarely.14,17-18
Muscle pain
Myalgia. Clinical research found this to occur in 15% to 50% of cases.7-8,14,19-20
Tendonitis
Inflammation of a tendon.7-8
Elevated liver enzymes
Hepatotoxicity. Clinical research found this to occur in 15% of cases.3
Low back pain
Clinical research found this to occur in 30% of cases.
Alopecia
Alopecia is a condition that results in loss of hair from the scalp and sometimes other areas of the body. Rare cases have been reported.7
Headaches
Clinical research found this occurred in 10% to 28% of cases.8
Depression
Depression and suicide have been linked to Accutane in clinical research but as data mounts, it appears unlikely that depression is more commn in people as a result of taking Accutane. More research on the connection between suicide, depression and Accutane is needed. See the Suicide & Depression tab for more detailed information on the topic.21-22
Reduced blood flow to
 the brain
AKA Cerebral ischemia. Clinical research found this to be extremely rare.23
Hearing impairment
"Has been reported" and "may persist after therapy has been discontinued."8
Yellowish deposits on
 eyelids
AKA Xanthomas. Clinical research found this to rarely occur.
Dry skin
AKA Xerosis. Clinical research found this to occur in 57% of cases.3,7-8
Dry lips
Clinical research found this to occur in 92% of cases.3,8
Dry mouth
Increased sunburn
 susceptibility
Oozing, bleeding skin
 bumps
Abnormal blood tests
Elevated triglycerides, cholesterol, transaminase. Clinical research found this to occur in 44%, 31%, and 11% of cases respectively.8,24-25
Low blood platelet count
AKA Thrombocytopenia.
Blood disease
AKA Agranulocytosis. Clinical research found this to be rare but life-threatening.
Low iron content in blood
AKA Anemia.
Arthritis
Temporary yet painful inflammation and stiffness of the joints.8,15
Respiratory symptoms
including difficulty breathing (bronchospasms, respiratory infection, and voice alteration).8
Low white blood cell count
AKA Neutropenia.26
Inflamed pancreas
AKA Pancreatitis. Clinical research found this to rarely occur.
Inflammatory bowel disease/Crohn's disease/Ulcerative colitis
Clinical research found no correlation between Accutane and inflammatory bowel disease or Crohn's disease, and a weak correlation with ulcerative colitis.27-28
Abnormal menses (women)

References

1. Rademaker M. "Adverse effects of isotretinoin: A retrospective review of 1743 patients started on isotretinoin." Australasian Journal of Dermatology. 2010; 51(4): 248-253.

2. Honein MA, Paulozzi LJ and Erickson JD. "Continued occurrence of Accutane-exposed pregnancies." Teratology. 2001; 64(3): 142-7.

3. Brelsford M and Beute TC. "Preventing and managing the side effects of isotretinoin." Seminars in Cutaneous Medicine and Surgery. 2008; 27(3): 197-206.

4. Berard A, et al. "Isotretinoin, pregnancies, abortions and birth defects: a population-based perspective." British Journal of Clinical Pharmacology. 2007; 63(2): 196-205.

5. Abroms L, et al. "What is the best approach to reducing birth defects associated with isotretinoin?" PLoS Medicine. Nov; 3(11): e483.

6. Shin J, et al. "The impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system." Journal of the American Academy of Dermatology. 2011 May 10.

7. Goulden V, Layton AM and Cunliffe WJ. "Long-term safety of isotretinoin as a treatment for acne vulgaris." British Journal of Dermatology. 1994; 131(3): 360-3.

8. McLane J. "Analysis of common side effects of isotretinoin." Journal of the American Academy of Dermatology. 2001; 45(5): S188-94.

9. Burkhart CG. "Another threat to the availability of isotretinoin: ocular side effects have aviation authorities considering restricting use from (even potential) pilots." Dermatology Online Journal. 2008; 14(7): 2.

10. Barzilai A, et al. "Seborrheic dermatitis-like eruption in patients taking isotretinoin therapy for acne: retrospective study of five patients." American Journal of Clinical Dermatology. 2008; 9(4): 255-61.

11. DiGiovanna JJ. "Isotretinoin effects on bone." Journal of the American Academy of Dermatology. 2001; 45(5): S176-82.

12. DiGiovanna JJ, et al. "Effect of a single course of isotretinoin therapy on bone mineral density in adolescent patients with severe, recalcitrant, nodular acne." Journal of the American Academy of Dermatology. 2004; 51(5): 709-17.

13. Eksioglu E, et al. "Sacroiliitis and polyneuropathy during isotretinoin treatment." Clinical and Experimental Dermatology. 2008; 33(2): 122-4.

14. De Francesco V, Stinco G and Campanella M. "Acute arthritis during isotretinoin treatment for acne conglobata." Dermatology. 1997; 194(2): 195.

15. Bewley AP, et al. "Isotretinoin causing acute aseptic arthropathy." Clinical and Experimental Dermatology. 1995; 20(3): 279.

16. Kaplan G and Haettich B. "Rheumatological symptoms due to retinoids." Bailliere's Clinical Rheumatology. 1991; 5(1): 77-97.

17. Hughes RA. "Arthritis precipitated by isotretinoin treatment for acne vulgaris." The Journal of Rheumatology. 1993; 20(7): 1241-2.

18. Lehucher Ceyrac D. "Acute arthritis after isotretinoin." Dermatology. 1999; 198(4): 406-7.

19. Kaymak Y, et al. "Creatine phosphokinase values during isotretinoin treatment for acne." International Journal of Dermatology. 2008; 47(4): 398-401.

20. Dicken CH. "Retinoids: A Review." Journal of American Academy of Dermatology. 1984;11:541-552.

21. Kaymak Y, Taner E and Taner Y. "Comparison of depression, anxiety and life quality in acne vulgaris partients who were treated with either isotretinoin or topical agents." International Journal of Dermatology. 2009; 48(1): 41-46.

22. Sundstrom A, et al. "Association of suicide attempts with acne and treatment with isotretinoin: Retrospective Swedish cohort study." British Medical Journal. 2010 Nov. 11.

23. Laroche ML, et al. "Cerebral ischemia probably related to isotretinoin." The Annals of Pharmacotherapy. 2007; 41(6): 1073-1076.

24. Zane LT, et al. "A population-based analysis of laboratory abnormalities during isotretinoin therapy for acne vulgaris." Archives of Dermatology. 2006; 142(8): 1016-22.

25. Karadag AS, et al. "Short-term isotretinoin treatment decreases insulin-like growth factor-1 and insulin-like growth factor binding protein-3 levels: Does isotretinoin affect growth hormone physiology?" British Journal of Dermatology. 2010; 162(4): 798-802.

26. Ozdemir MA, et al. "Isotretinoin-induced agranulocytosis." Pediatric Dermatology. 2007; 24(4): 425-6.

27. Reddy D, et al. "Possible association between isotretinoin and inflammatory bowel disease." American Journal of Gastroenterology. 2006; 101(7): 1569-73.

28. Crockett SD, et al. "Isotretinoin use and the risk of inflammatory bowel disease: A case-control study." The American Journal of Gastroenterology. 2010; 105(9): 1986-1993.

Further Reading

Dopheide MM and Morgan RE. "Isotretinoin (13-cis-retinoic acid) alters learning and memory, but not anxiety-like behavior, in the adult rat." Phamacology Biochemistry and Behavior. 2008; 91(2): 243-51.

Fraunfelder FT, Fraunfelder FW and Edwards R. "Ocular side effects possibly associated with isotretinoin usage." American Journal of Oprhamology. 2001; 132(3): 299-305.

Fraunfelder FW. "Ocular side effects associated with isotretinoin." Drugs Today. 2004; 40(1): 23-7.

Hull PR, Demkiw-Bartel C. "Isotretinoin use in acne: prospective evaluation of adverse events." Journal of Cutaneous Medicine and Surgery. 2000; 4(2): 66-70.

Lamb SR and Oakley AMM. "Adverse effects of isotretinoin therapy for acne vulgaris." New England Medical Journal. 2001; 144(1139): 414.

Nau H. "Teratogenicity of isotretinoin revisited: species variation and the role of all-trans-retinoic acid." Journal of the American Academy of Dermatology. 2001; 45(5): S183-7.

Passier JL, Srivastava N and van Puijenbroek EP. "Isotretinoin-induced inflammatory bowel disease." The Netherlands Journal of Medicine. 2006; 64(2): 52-4.

Roche Accutane (isotretinoin capsules). Roche Laboratories, Inc. Oct. 2007.

Scheinfeld N and Bangalore S. "Facial edema induced by isotretinoin use: a case and a review of the side effects of isotretinoin." Journal of Drugs in Dermatology. 2006; 5(5): 467-8.

Selcoki Y, et al. "Isotretinoin: is there any arrhythmic effect?" International Journal of Dermatology. 2008; 47(2): 195-7.

Szabo B. "Antiandrogenic effect of isotretinoin: is the retina involved in mechanism of action?" Medical Hypotheses. 2007; 69(6): 1281-3.

Tekin NS, et al. "Bone mineral density and bone turnover markers in patients receiving a single course of isotretinoin for nodulocystic acne." International Journal of Dermatology. 2008; 47(6): 622-5.

Van Durme D. "Family Physicians and Accutane." American Family Physician. 2000; 62(8): 1772-74.