These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA. STENDRA® (avanafil) tablets, for oral use.
Initial U.S. Approval: 2012
Warnings and Precautions, Effects on the Eye (5.4) 04/2014
Dosage and Administration (2.1) 09/2014
Contraindications, Concomitant Guanylate Cyclase (GC)
Stimulators (4.3) 09/2015
STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (1)
Tablets: 50 mg, 100 mg, 200 mg (3)
Most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact 866.928.6180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION and FDA approved patient labeling Revised: 12/2016
Please see full Prescribing Information
Reference: 1. STENDRA [package insert]. Mist Pharmaceuticals. 2015.
References: 1. STENDRA [package insert]. Mist Pharmaceuticals. 2015. 2. Viagra® [package insert]. Pfizer Inc. 2015. 3. Levitra® [package insert]. Bayer Healthcare Pharmaceuticals Inc. 2015. 4. Staxyn® [package insert]. Bayer Healthcare Pharmaceuticals Inc. 2015. 5. Cialis® [package insert]. Eli Lilly and Company. 2016. 6. Goldstein I, McCullough AR, Jones LA, et al. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction. J Sex Med. 2012;9(4):1122-1133. 7. Goldstein I, Jones LA, Belkoff LH, et al. Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus. Mayo Clin Proc. 2012;87(9):843-852. 8. Data on File. Clinical Study Report. Mist Pharmaceuticals. 2014. 9. Mulhall JP, Burnett AL, Wang R, et al. A phase 3, placebo controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve sparing radical prostatectomy. J Urol. 2013;189(6):2229-2236. 10. Belkoff LH, McCullough A, Goldstein I, et al. An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Int J Clin Pract. 2013;67(4):333-341.