MinoLira™ has an established safety and efficacy profile

  • The active ingredient in MinoLira has a long-term track record of efficacy.5
  • MinoLira tablets are well-tolerated, with an AE profile similar to placebo.1
  • With MinoLira, the risk of GI upset is low.1

Adverse Reaction
Adverse Reaction
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
Placebo N = 364
Placebo N = 364
Adverse Reaction
At least one treatment-emergent event
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
379 (56%)
Placebo N = 364
197 (54%)
Adverse Reaction
Headache
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
152 (23%)
Placebo N = 364
83 (23%)
Adverse Reaction
Fatigue
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
62 (9%)
Placebo N = 364
24 (7%)
Adverse Reaction
Dizziness
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
59 (9%)
Placebo N = 364
17 (5%)
Adverse Reaction
Pruritis
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
31 (5%)
Placebo N = 364
16 (4%)
Adverse Reaction
Malaise
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
26 (5%)
Placebo N = 364
9 (3%)
Adverse Reaction
Mood alteration
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
17 (3%)
Placebo N = 364
9 (3%)
Adverse Reaction
Somnolence
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
13 (2%)
Placebo N = 364
9 (1%)
Adverse Reaction
Urticaria
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
10 (2%)
Placebo N = 364
3 (1%)
Adverse Reaction
Tinnitus
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
10 (2%)
Placebo N = 364
1 (0%)
Adverse Reaction
Arthralgia
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
9 (1%)
Placebo N = 364
1 (0%)
Adverse Reaction
Vertigo
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
8 (1%)
Placebo N = 364
1 (0%)
Adverse Reaction
Dry Mouth
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
7 (1%)
Placebo N = 364
1 (0%)
Adverse Reaction
Myalgia
Minocycline Hydrochloride
Sustained-Release Tablets (1mg/kg) N = 674
7 (1%)
Placebo N = 364
1 (0%)
minolira--savings-card
MINOLIRA is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

MINOLIRA did not demonstrate any effect on non-inflammatory acne lesions. Safety of MINOLIRA has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, MINOLIRA should be used only as indicated.
  • This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
  • Minocycline, like other tetracycline-class drugs, can cause fetal harm when administered to a pregnant woman.
  • The use of MINOLIRA during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth.
  • If pseudomembranous colitis occurs, discontinue MINOLIRA.
  • If renal impairment exists, MINOLIRA doses may need to be adjusted to avoid accumulations of the drug and possible liver toxicity.
  • Minocycline may cause central nervous system side effects, including light-headedness, dizziness, or vertigo.
  • Minocycline may cause intracranial hypertension and autoimmune disorders in adults and adolescents. Discontinue MINOLIRA if symptoms occur.
  • Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and DRESS syndrome. Discontinue MINOLIRA immediately if symptoms occur.
  • The most commonly observed adverse reactions are headache, fatigue, dizziness, and pruritus.

To report SUSPECTED ADVERSE REACTIONS contact EPI Health, LLC at 1-800-499-4468 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.