Isotretinoin (Accutane®)

Oral Retinoid
Compare To Other Treatments

The following side effects are expected to occur during treatment with isotretinoin. Contact your doctor if these symptoms are severe and/or do not go away on stopping treatment:

How Common (based on clinical studies)

Sore, cracked, or red lipsUp to 100% of all users
Dryness of skin, mouth, nose, or eyesUp to 100% of all users
Skin peeling on palms and solesUp to 92.9% of all users
NosebleedsUp to 66.7% of all users
ItchingUp to 57.1% of all users
Changes in laboratory tests, such as in levels of fats in the bloodUp to 57%
Hair loss or unwanted growth of hairUp to 29% of all users
Soreness of the mouthUp to 28.6% of all users
Fatigue or tirednessUp to 27% of all users
Sleep disturbances / insomniaUp to 22% of all users
Decreased appetiteUp to 17% of all users
Eczema (itchy and inflamed skin)Up to 12.1% of all users
SunburnsUp to 12% of all users
Changes in moodUp to 7.1% of all users
Increased or decreased sweatingUp to 6.7% of all users
Cracking of skin or crustingUp to 6.7% of all users
Dry hairUp to 6.7% of all users
Pterygium (a growth on the eye) Up to 6.7% of all users
Extreme sensitivity to light (photophobia)Up to 6.7% of all users
Bleeding or swelling of gumsUnknown
Delayed wound healingUnknown
Episodes of flushingUnknown
Changes in the appearance of the nailsUnknown
Voice changesUnknown
Symptoms of a coldUnknown
Discoloration of the skinUnknown

Some side effects of isotretinoin can be serious. If you experience any of the following side effects, or any of those mentioned in the “Important Warning” or “Be aware of” sections, stop using isotretinoin immediately and contact your doctor or get emergency medical care right away:

  • Nausea
  • Vomiting
  • Headaches
  • Feeling faint or dizzy
  • Episodes of fainting
  • Blurring of vision or any other changes in vision
  • Seizures
  • Speech difficulty or slowing of speech
  • Numbness or weakness of one side or one part of the body
  • Abdominal pain
  • Appearance of sores in the eyes, nose, mouth, or throat
  • Difficulty or pain during swallowing
  • New feelings of heartburn or worsening of existing heartburn
  • Chest pain
  • Diarrhea or watery stools
  • Bleeding from the rectum or blood in stools
  • Bone, joint, or muscle pains
  • Back pain
  • Muscle weakness
  • Unexplained bruises or red patches on the legs
  • Yellowed skin or eyes
  • Dark yellow-brown urine
  • Changes in hearing
  • Ringing in the ears
  • Rash on face or other areas of the body
  • Pain in the eyes
  • Persistent dryness of the eyes
  • Skin peeling and blistering, particularly over the face, arms, or legs
  • Unusually increased amounts of thirst
  • Increased frequency of urination
  • Pounding or fast heartbeat
  • Itchy, red, swollen and teary eyes (pink eye)
  • Fever
  • Swelling in any part of the body

Isotretinoin may also cause other side effects that are not mentioned here. Contact your doctor if you experience any other troublesome symptoms when using isotretinoin.

  1. UpToDate. Isotretinoin (oral): drug information. Available from: Cited 30 November 2016.
  2. Dailymed- U.S. National Library of Medicine. Isotretinoin, oral. Available from:  Cited 30 November 2016.
  3. Farrell, L. N., Strauss, J. S., & Stranieri, A. M. The treatment of severe cystic acne with 13-cis-retinoic acid: evaluation of sebum production and the clinical response in a multiple-dose trial. Journal of the American Academy of Dermatology, 3(6), 602-611 (1980)
  4. Jones, D. H., King, K., Miller, A., & Cunliffe, W. J. A dose‐response study of 13‐cis‐retinoic acid in acne vulgaris. British Journal of Dermatology, 108(3), 333-343 (1983)
  5. Strauss, J. S., Rapini, R. P., Shalita, A. R., Konecky, E., Pochi, P. E., Comite, H., & Exner, J. H. Isotretinoin therapy for acne: results of a multicenter dose-response study. Journal of the American Academy of Dermatology, 10(3), 490-496 (1984)
  6. Shahidullah, M., Tham, S. N., & Goh, C. L. Isotretinoin therapy in acne vulgaris: A 10‐year retrospective study in Singapore. International journal of dermatology, 33(1), 60-63 (1994)
  7. Kaymak, Y., & Ilter, N. The results and side effects of systemic isotretinoin treatment in 100 patients with acne vulgaris. Dermatology Nursing, 18(6), 576 (2006)
  8. Agarwal, U. S., Besarwal, R. K., & Bhola, K. Oral isotretinoin in different dose regimens for acne vulgaris: a randomized comparative trial. Indian Journal of Dermatology, Venereology, and Leprology, 77(6), 688 (2011)
  9. Lee, J. W., Yoo, K. H., Park, K. Y., Han, T. Y., Li, K., Seo, S. J., & Hong, C. K. Effectiveness of conventional, low‐dose and intermittent oral isotretinoin in the treatment of acne: a randomized, controlled comparative study. British Journal of Dermatology, 164(6), 1369-1375 (2011)
  10. Rademaker, M., Wishart, J. M., & Birchall, N. M. Isotretinoin 5 mg daily for low‐grade adult acne vulgaris–a placebo‐controlled, randomized double‐blind study. Journal of the European Academy of Dermatology and Venereology, 28(6), 747-754 (2014)
  11. Ahmad, H. M. Analysis of clinical efficacy, side effects, and laboratory changes among patients with acne vulgaris receiving single versus twice daily dose of oral isotretinoin. Dermatologic therapy, 28(3), 151-157 (2015)
  12. Lester, R. S., Schachter, G. D., & Light, M. J. Isotretinoin and tetracycline in the management of severe nodulocystic acne. International journal of dermatology, 24(1), 252-257 (1985)
  13. Oprica, C., Emtestam, L., Hagströmer, L., & Nord, C. E. Clinical and microbiological comparisons of isotretinoin vs. tetracycline in acne vulgaris. Acta dermato-venereologica, 87(3), 246-254 (2007)
  14. Tan, J., et al. A treatment for severe nodular acne: a randomized investigator‐blinded, controlled, noninferiority trial comparing fixed‐dose adapalene/benzoyl peroxide plus doxycycline vs. oral isotretinoin. British Journal of Dermatology, 171(6), 1508-1516 (2014)
  15. Jacobs, D. G., Deutsch, N. L., & Brewer, M. Suicide, depression, and isotretinoin: is there a causal link?. Journal of the American Academy of Dermatology, 45(5), S168-S175 (2001).
  16. Hull, P. R., & D’Arcy, C.  Isotretinoin use and subsequent depression and suicide. American journal of clinical dermatology, 4(7), 493-505 (2003).
  17. Strahan, J. E., & Raimer, S. Isotretinoin and the controversy of psychiatric adverse effects. International journal of dermatology, 45(7), 789-799 (2006).
  18. Magin, P., Pond, D., & Smith, W. Isotretinoin, depression and suicide: a review of the evidence. British Journal of General Practice, 55(511), 134-138 (2005).
  19. Kaymak, Y., Taner, E., & Taner, Y. Comparison of depression, anxiety and life quality in acne vulgaris patients who were treated with either isotretinoin or topical agents. International journal of dermatology, 48(1), 41-46 (2009).
  20. Suarez, B., Serrano, A., Cova, Y., & Baptista, T. Isotretinoin was not associated with depression or anxiety: A twelve-week study. World journal of psychiatry, 6(1), 136 (2016).
  21. Rosa, F. Teratogenicity of isotretinoin. The Lancet, 322(8348), 513 (1983).
  22. Zomerdijk, I. M., Ruiter, R., Houweling, L. M., Herings, R. M., Sturkenboom, M. C., Straus, S. M., & Stricker, B. H. Isotretinoin exposure during pregnancy: a population-based study in The Netherlands. BMJ open, 4(11), e005602 (2014).
  23. Lee, Y. H., Scharnitz, T. P., Muscat, J., Chen, A., Gupta-Elera, G., & Kirby, J. S. Laboratory monitoring during isotretinoin therapy for acne: a systematic review and meta-analysis. JAMA dermatology, 152(1), 35-44 (2016)
  24. Etminan, M., Bird, S. T., Delaney, J. A., Bressler, B., & Brophy, J. M. Isotretinoin and risk for inflammatory bowel disease: a nested case-control study and meta-analysis of published and unpublished data. JAMA dermatology, 149(2), 216-220 (2013).
  25. Racine, et al. Isotretinoin and risk of inflammatory bowel disease: a French nationwide study. The American journal of gastroenterology, 109(4), 563 (2014).
  26. Lee, S. Y., Jamal, M. M., Nguyen, E. T., Bechtold, M. L., & Nguyen, D. L. Does exposure to isotretinoin increase the risk for the development of inflammatory bowel disease? A meta-analysis. European journal of gastroenterology & hepatology, 28(2), 210-216 (2016).
  27. Lebwohl, B., Sundström, A., Jabri, B., Kupfer, S. S., Green, P. H., & Ludvigsson, J. F. Isotretinoin use and celiac disease: a population-based cross-sectional study. American journal of clinical dermatology, 15(6), 537-542 (2014).
  28. Rashtak, S., Khaleghi, S., Marietta, E. V., Pittelkow, M. R., Larson, J. J., Lahr, B. D., & Murray, J. A. Isotretinoin Exposure and Risk of Celiac Disease. PloS one, 10(8), e0135881 (2015).
  29. DiGiovanna, J. J., 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, 51(5), 709-717 (2004).
  30. Tekin, N. S., Ozdolap, S., Sarikaya, S., & Keskin, S. I. Bone mineral density and bone turnover markers in patients receiving a single course of isotretinoin for nodulocystic acne. International journal of dermatology, 47(6), 622-625 (2008).
  31. Neudorfer, M., Goldshtein, I., Shamai-Lubovitz, O., Chodick, G., Dadon, Y., & Shalev, V. Ocular adverse effects of systemic treatment with isotretinoin. Archives of dermatology, 148(7), 803-808 (2012).
  32. Rademaker, M. Adverse effects of isotretinoin: A retrospective review of 1743 patients started on isotretinoin. Australasian Journal of Dermatology, 51(4), 248-253  (2010).