Version July 2025
Acne vulgaris, inflammatory, moderate to severe:
Note: Use in combination with topical acne therapy. Treatment should ideally be limited to 3 to 4 months to minimize the risk of resistance (Ref).
Oral: Dosage based on body weight (Ref):
33 to 54 kg: 60 mg once daily.
55 to 84 kg: 100 mg once daily.
85 to 136 kg: 150 mg once daily.
There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant differences in the pharmacokinetics of sarecycline were observed.
Mild to moderate impairment (Child-Pugh class A or B): There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant differences in the pharmacokinetics of sarecycline were observed.
Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Sarecycline: Pediatric drug information")
Acne vulgaris (non-nodular), moderate to severe: Note: If no improvement after 12 weeks, reassess treatment. Children ≥9 years and Adolescents: Oral:
33 to <55 kg: 60 mg once daily
55 to <85 kg: 100 mg once daily
85 to 136 kg: 150 mg once daily
There are no dosage adjustments provided in the manufacturer's labeling. No clinical differences in the pharmacokinetics of sarecycline were noted in renal impairment; the effect of end-stage renal disease has not been studied.
There are no dosage adjustments provided in the manufacturer's labeling. No clinical differences in the pharmacokinetics of sarecycline were noted in mild to moderate hepatic impairment; the effect of severe hepatic impairment has not been studied.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%: Gastrointestinal: Nausea (3%)
<1%, postmarketing, and/or case reports: Vulvovaginal candidiasis, vulvovaginal infection
Hypersensitivity to sarecycline, tetracyclines, or any component of the formulation.
Concerns related to adverse effects:
• CNS effects: Lightheadedness, dizziness, and vertigo may occur; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Symptoms usually disappear with continued therapy and when the drug is discontinued.
• Intracranial hypertension: Intracranial hypertension has been associated with use of tetracyclines; headache, blurred vision, and/or papilledema may occur. Women of childbearing age who are overweight are at greater risk. Concomitant use of isotretinoin (known to cause intracranial hypertension) and sarecycline should be avoided. Intracranial hypertension typically resolves after discontinuation of treatment; however, permanent visual loss is possible. If visual symptoms develop during treatment, prompt ophthalmologic evaluation is warranted.
• Photosensitivity: May cause photosensitivity; discontinue if skin erythema occurs. Use skin protection and avoid prolonged exposure to sunlight; do not use tanning equipment.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including Clostridioides difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Special populations:
• Pediatric: May cause tissue hyperpigmentation, tooth enamel hypoplasia, or permanent tooth discoloration (more common with long-term use, but observed with repeated, short courses) when used during tooth development (last half of pregnancy, infancy, and childhood ≤8 years of age).
Do not administer to children <8 years of age due to permanent discoloration of teeth and retardation of skeletal development and bone growth; more common with long-term use, but may be observed with repeated, short courses. Pseudotumor cerebri has been reported rarely in infants and adolescents; use with isotretinoin has been associated with cases of pseudotumor cerebri; avoid concomitant treatment with isotretinoin.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as hydrochloride:
Seysara: 60 mg, 100 mg, 150 mg [contains quinoline (d&c yellow #10) aluminum lake]
No
Tablets (Seysara Oral)
60 mg (per each): $43.43
100 mg (per each): $43.43
150 mg (per each): $43.43
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Oral: May be administered with or without food. Administer with adequate fluid to decrease the risk of esophageal irritation and ulceration. Separate administration of antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.
Oral: Administer with or without food; administer with plenty of fluid to reduce the risk of esophageal irritation and ulceration.
Acne vulgaris, inflammatory, moderate to severe: Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients ≥9 years.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid
Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor
Antacids: May decrease absorption of Tetracyclines. Management: Separate administration of antacids and oral tetracycline derivatives by several hours when possible to minimize the extent of this potential interaction. Monitor for decreased therapeutic effects of tetracyclines. Risk D: Consider Therapy Modification
Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification
BCG (Intravesical): Antibiotics may decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid
BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor
Bile Acid Sequestrants: May decrease absorption of Tetracyclines. Risk C: Monitor
Bismuth Subcitrate: May decrease serum concentration of Tetracyclines. Management: Avoid administration of oral tetracyclines within 30 minutes of bismuth subcitrate administration. This is of questionable significance for at least some regimens intended to treat H. pylori infections. Risk D: Consider Therapy Modification
Bismuth Subsalicylate: May decrease serum concentration of Tetracyclines. Management: Consider dosing tetracyclines 2 hours before or 6 hours after bismuth. The need to separate doses during Helicobacter pylori eradication regimens is questionable. Risk D: Consider Therapy Modification
Calcium Salts: May decrease serum concentration of Tetracyclines. Management: If coadministration of oral calcium with oral tetracyclines cannot be avoided, consider separating administration of each agent by several hours. Risk D: Consider Therapy Modification
Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid
Digoxin: Sarecycline may increase serum concentration of Digoxin. Risk C: Monitor
Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid
Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor
Iron Preparations: Tetracyclines may decrease absorption of Iron Preparations. Iron Preparations may decrease serum concentration of Tetracyclines. Management: Avoid this combination if possible. Administer oral iron preparations at least 2 hours before, or 4 hours after, the dose of the oral tetracycline derivative. Monitor for decreased therapeutic effect of oral tetracycline derivatives. Risk D: Consider Therapy Modification
Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor
Lanthanum: May decrease serum concentration of Tetracyclines. Management: Administer oral tetracycline antibiotics at least 2 hours before or after lanthanum. Risk D: Consider Therapy Modification
Lithium: Tetracyclines may increase serum concentration of Lithium. Risk C: Monitor
Magnesium Dimecrotate: And Tetracyclines may interact via an unclear mechanism. Risk C: Monitor
Magnesium Salts: May decrease absorption of Tetracyclines. Only applicable to oral preparations of each agent. Management: Avoid coadministration of oral magnesium salts and oral tetracyclines. If coadministration cannot be avoided, administer oral magnesium at least 2 hours before, or 4 hours after, oral tetracyclines. Monitor for decreased tetracycline therapeutic effects. Risk D: Consider Therapy Modification
Mecamylamine: Tetracyclines may increase neuromuscular-blocking effects of Mecamylamine. Risk X: Avoid
Methotrexate: Tetracyclines may increase serum concentration of Methotrexate. Risk C: Monitor
Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor
Methoxyflurane: Tetracyclines may increase nephrotoxic effects of Methoxyflurane. Risk X: Avoid
Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease serum concentration of Tetracyclines. Management: Avoid this combination if possible. If coadministration cannot be avoided, administer the polyvalent cation-containing multivitamin at least 2 hours before or 4 hours after the tetracycline derivative. Monitor for decreased tetracycline effects. Risk D: Consider Therapy Modification
Multivitamins/Minerals (with AE, No Iron): May decrease serum concentration of Tetracyclines. Management: If coadministration of a polyvalent cation-containing multivitamin with oral tetracyclines cannot be avoided, administer the polyvalent cation-containing multivitamin either 2 hours before or 4 hours after the tetracycline product. Risk D: Consider Therapy Modification
Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor
Neuromuscular-Blocking Agents: Tetracyclines may increase neuromuscular-blocking effects of Neuromuscular-Blocking Agents. Risk C: Monitor
Penicillins: Tetracyclines may decrease therapeutic effects of Penicillins. Risk C: Monitor
Polyethylene Glycol-Electrolyte Solution: May decrease absorption of Tetracyclines. Management: Give oral tetracyclines at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider Therapy Modification
Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid
Quinapril: May decrease serum concentration of Tetracyclines. Risk C: Monitor
Retinoic Acid Derivatives: Tetracyclines may increase adverse/toxic effects of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Risk X: Avoid
Sodium Bicarbonate (Systemic): May decrease serum concentration of Tetracyclines. Risk C: Monitor
Sodium Picosulfate: Antibiotics may decrease therapeutic effects of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider Therapy Modification
Strontium Ranelate: May decrease serum concentration of Tetracyclines. Management: In order to minimize any potential impact of strontium ranelate on tetracycline antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during tetracycline therapy. Risk X: Avoid
Sucralfate: May decrease absorption of Tetracyclines. Management: Administer most tetracycline derivatives at least 2 hours prior to sucralfate in order to minimize the impact of this interaction. Administer oral omadacycline 4 hours prior to sucralfate. Risk D: Consider Therapy Modification
Sucroferric Oxyhydroxide: May decrease serum concentration of Tetracyclines. Management: Administer oral/enteral doxycycline at least 1 hour before sucroferric oxyhydroxide. Specific dose separation guidelines for other tetracyclines are not presently available. No interaction is anticipated with parenteral administration of tetracyclines. Risk D: Consider Therapy Modification
Sulfonylureas: Tetracyclines may increase hypoglycemic effects of Sulfonylureas. Risk C: Monitor
Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification
Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor
Vitamin K Antagonists: Tetracyclines may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor
Zinc Salts: May decrease absorption of Tetracyclines. Only a concern when both products are administered orally. Management: Separate administration of oral tetracycline derivatives and oral zinc salts by at least 2 hours to minimize this interaction. Risk D: Consider Therapy Modification
Tetracycline-class antibiotics may cause fetal harm following maternal use in pregnancy. Tetracyclines accumulate in developing teeth and long tubular bones. Permanent discoloration of teeth (yellow, gray, brown) can occur following in utero exposure and is more likely to occur following long-term or repeated exposure. Reversible inhibition of bone growth may occur following maternal use of tetracyclines in the second and third trimesters. Sarecycline should be discontinued immediately if pregnancy occurs during treatment.
It is not known if sarecycline is present in breast milk.
As a class, tetracyclines have generally been avoided in breastfeeding females due to concerns that they may cause adverse events in the breastfeeding infant, including tooth discoloration and inhibition of bone growth. Due to the potential for adverse events, breastfeeding is not recommended by the manufacturer.
Ophthalmologic evaluation if visual disturbances occur
Sarecycline is an aminomethylcycline within the tetracycline class that binds to the 30S ribosomal subunit and interacts with 16S ribosomal RNA; it also protrudes its C7 moiety into the mRNA binding channel to interact with mRNA, thereby preventing Propionibacterium acnes protein synthesis and inhibiting bacterial growth.
Distribution: Vd: 91.4 to 97 L
Protein binding: 62.5% to 74.7%
Metabolism: Minimal (<15%) in vitro
Half-life elimination: 21 to 22 hours
Time to peak: 1.5 to 2 hours; delayed by ~0.53 hour when administered with high-fat, high-calorie meal that included milk
Excretion: Feces (42.6%; 14.9% as unchanged drug); Urine (44.1%; 24.7% as unchanged drug)
