Tigecycline

Tigecycline is a tetracycline class antibacterial [see Microbiology ( 12.4 )] .

• Tigecycline for injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: Complicated skin and skin structure infections ( 1.1 ) Complicated intra-abdominal infections ( 1.2 ) Community-acquired bacterial pneumonia ( 1.3 ) Limitations of Use: Tigecycline for injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia ( 1.4 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of tigecycline for injection and other antibacterial drugs, tigecycline for injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria ( 1.5 ).ICD-10: J18.9

• Tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline or to any of the excipients. Reactions have included anaphylactic reactions [ see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.2 ) ] .contraindicated

Initial dose of 100 mg, followed by 50 mg every 12 hours administered intravenously over approximately 30 to 60 minutes. (2.1) Severe hepatic impairment (Child Pugh C): Initial dose of 100 mg followed by 25 mg every 12 hours. ( 2.2 ) Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with tigecyclineetracycline. ( 2.4 , 5.6 ) 2.1 Recommended Adult Dosage The recommended dosage regimen for tigecycline for injection is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous infusions of tigecycline for injection should be administered over approximately 30 to 60 minutes every 12 hours. The recommended duration of treatment with tigecycline for injection for complicated skin and skin structure infections or for complicated intra-abdominal infections is 5 to 14 days. The recommended duration of treatment with tigecycline for injection for community-acquired bacterial pneumonia is 7 to 14 days. The duration of therapy should be guided by the severity and site of the infection and the patient's clinical and bacteriological progress. 2.2 Dosage in Patients With Hepatic Impairment No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B). In patients with severe hepatic impairment (Child Pugh C), the initial dose of tigecycline for injection should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours.

All-Cause Mortality: A meta-analysis of Phase 3 and 4 clinical trials demonstrated an increase in all-cause mortality in tigecycline-treated patients compared to controls with a risk difference of 0.6% (95% CI 0.1, 1.2). The cause of this increase has not been established. An increase was also seen in a meta-analysis limited to the approved indications [0.6% (95% CI 0, 1.2)]. The greatest difference in mortality was seen in tigecycline-treated patients with ventilator-associated pneumonia. ( 5.1 , 5.2 ) Anaphylactic Reactions: have been reported with tigecycline for injection, and may be life-threatening. Avoid use in patients with known hypersensitivity to tetracyclines. ( 5.3 ) Hepatic Adverse Effects: have been reported with tigecycline for injection. Patients who develop abnormal liver function tests during tigecycline for injection therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing tigecycline therapy. ( 5.4 ) Pancreatitis: including fatalities, has been reported with tigecycline for injection. If pancreatitis is suspected, then consider stopping tigecycline for injection. ( 5.5 ) Monitoring Blood Coagulation Parameters: Hypofibrinogenemia has been reported with tigecycline for injection. Monitor blood coagulation parameters, including fibrinogen, at baseline and regularly during treatment with tigecycline for injection.

The following serious adverse reactions are described elsewhere in the labeling: All-Cause Mortality [see Boxed Warning and Warnings and Precautions ( 5.1 )] Mortality Imbalance and Lower Cure Rates in Hospital-Acquired Pneumonia [see Warnings and Precautions ( 5.2 )] Anaphylaxis [Warning and Precautions ( 5.3 )] Hepatic Adverse Effects [Warnings and Precautions ( 5.4 )] Pancreatitis [Warnings and Precautions ( 5.5 )] The most common adverse reactions (incidence >5%) are nausea, vomiting, diarrhea, abdominal pain, headache, and increased SGPT. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 2,514 patients were treated with tigecycline for injection. Tigecycline for injection was discontinued due to adverse reactions in 7% of patients compared to 6% for all comparators. Table 1 shows the incidence of adverse reactions through test of cure reported in ≥2% of patients in these trials. Table 1. Incidence (%) of Adverse Reactions Through Test of Cure Reported in ≥ 2% of Patients Treated in Clinical Studies Body System Tigecycline for injection Comparators a Adverse Reactions (N=2,514) (N=2,307) a Vancomycin/Aztreonam, Imipenem/Cilastatin, Levofloxacin, Linezolid.

Lactation: Avoid breastfeeding for longer than 3 weeks while taking tigecycline for injection. A lactating woman may also pump and discard breast milk during treatment and for 9 days after the last dose of tigecycline for injection ( 8.2 ) Pediatrics: Use in patients under 18 years of age is not recommended. Pediatric trials were not conducted because of the higher risk of mortality seen in adult trials ( 8.4 ) 8.1 Pregnancy Risk Summary Tigecycline for injection, like other tetracycline class antibacterial drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.7 , 5.8), Data, and Use in Specific Populations ( 8.4 )] . There are no available data on the risk of major birth defects or miscarriage following the use of tigecycline for injection during pregnancy. Administration of intravenous tigecycline in pregnant rats and rabbits during the period of organogenesis was associated with reduction in fetal weights and an increased incidence of skeletal anomalies (delays in bone ossification) at exposures of 5 and 1 times the human exposure at the recommended clinical dose in rats and rabbits, respectively. Advise the patient of the potential risk to the fetus if tigecycline for injection is used during the second or third trimester.

Metabolism

The mean pharmacokinetic parameters of tigecycline after single and multiple intravenous doses based on pooled data from clinical pharmacology studies are summarized in Table 3 . Intravenous infusions of tigecycline were administered over approximately 30 to 60 minutes.

No specific information is available on the treatment of overdosage with tigecycline. Intravenous administration of tigecycline for injection at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting. Tigecycline is not removed in significant quantities by hemodialysis.

• Jun 15, 2005NDANDA021821Pf Prism Cv
• May 27, 2015ANDAANDA091620Sandoz
• Aug 2, 2018NDANDA211158Amneal
• Dec 21, 2018ANDAANDA204439Apotex
• Jun 11, 2019ANDAANDA206335Eugia Pharma
• May 13, 2021ANDAANDA214020Meitheal

1. 1Drug Ineffective72912%
2. 2Off Label Use67611%
3. 3Nausea4026.7%
4. 4Vomiting2724.5%
5. 5Sepsis2674.5%
6. 6Death2594.3%
7. 7Thrombocytopenia2554.3%
8. 8Septic Shock2293.8%
9. 9Drug Resistance2123.5%
10. 10Diarrhoea2073.5%
11. 11Coagulopathy2043.4%
12. 12Pathogen Resistance2023.4%
13. 13Condition Aggravated1963.3%
14. 14Platelet Count Decreased1722.9%
15. 15Product Use In Unapproved Indication1702.8%

Recent PubMed references pinned to Tigecycline as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Retail pork markets as underrecognized hubs of tigecycline resistance: Genomic epidemiology of tet(X4)-harboring Escherichia coli and global ST195 dissemination.
  Food research international (Ottawa, Ont.) · 2026 · Chen J, Peng J, Wu Y, et al.
  PMID 42116424DOI 10.1016/j.foodres.2026.119086
• Population pharmacokinetics and probability of target attainment of tigecycline in critically ill children.
  The Journal of antimicrobial chemotherapy · 2026 · Hu W, Yuan Y, Tan B, et al.
  PMID 42085673DOI 10.1093/jac/dkag156
• Co-occurrence of the tigecycline resistance gene cluster tmexCD3-toprJ1 and verona integron-encoded metallo-β-lactamase (VIM) in a human-derived Pseudomonas sediminis isolate.
  Microbiology spectrum · 2026 · Shen H, Chen A, Cai C, et al.
  PMID 42059645DOI 10.1128/spectrum.03491-25
• Whole-Genome Insights Into Tigecycline-Resistant Klebsiella Spp. Harboring Colistin Resistance Gene From Food Animals in Türkiye.
  Transboundary and emerging diseases · 2026 · Kürekci C, Lu X, Şahin S, et al.
  PMID 42022448DOI 10.1155/tbed/9122655
• Characteristics and outcomes of patients treated with tigecycline for MDR gram-negative infections: a retrospective cohort study.
  Frontiers in cellular and infection microbiology · 2026 · Alowais SA, Aldairem A, Bin Saleh K, et al.
  PMID 41994202DOI 10.3389/fcimb.2026.1790441
• Resistance associated genomic variations for moderate level tigecycline resistance evolution in Acinetobacter baumannii.
  World journal of microbiology & biotechnology · 2026 · Acharya K, Biswas S, Bhattacharyya S, et al.
  PMID 41933192DOI 10.1007/s11274-026-04908-y
• Global genomic surveillance of tigecycline resistance gene tet(X) in Salmonella enterica.
  International journal of antimicrobial agents · 2026 · Wang J, Li W, Hou JQ, et al.
  PMID 41903705DOI 10.1016/j.ijantimicag.2026.107794
• Effect of sub-inhibitory tigecycline (½-MIC) on AcrAB-TolC and mar/ram/sox regulatory genes in Enterobacter cloacae complex isolates.
  Frontiers in cellular and infection microbiology · 2026 · Korczak L, Majewski P, Sacha P, et al.
  PMID 41822337DOI 10.3389/fcimb.2026.1745642

The 10 most recently updated of 94 ClinicalTrials.gov registrations naming Tigecycline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance
  Recruiting · Phase 4 · Interventional · 60 enrolled · National Taiwan University Hospital
  NCT07514364updated 2026-06-10
• Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
  Recruiting · Phase 2 · Phase 3 · Interventional · 300 enrolled · The University of Queensland
  NCT04310930updated 2026-05-11
• Comparing Efficacy and Safety of (Meropenem + Colistin) Versus (Imipenem/Cilastatin + Tigecycline) on Eradication of Multi-Drug Resistance Bacteria
  Not yet recruiting · Phase 2 · Interventional · 60 enrolled · Ain Shams University
  NCT07524920updated 2026-04-13
• Clinical Effectiveness of Tigecycline for Scrub Typhus.
  Completed · Interventional · 31 enrolled · Jin Soo Lee
  NCT07513103updated 2026-04-06
• Intracalvariosseous Plus Intravenous Antibiotics for Moderate-to-Severe Bacterial Meningitis
  Not yet recruiting · Interventional · 86 enrolled · yilong Wang
  NCT07495150updated 2026-03-27
• Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial
  Not yet recruiting · Phase 2 · Interventional · 300 enrolled · The University of Queensland
  NCT07485010updated 2026-03-20
• Efficacy of Taurolidine Containing Lock Solution for Prevention of Central Venous Catheter Infection in ICU Patients
  Completed · Interventional · 120 enrolled · Tanta University
  NCT07366372updated 2026-01-26
• The Efficacy and Adverse Reactions of Neotetracycline in the Treatment of GNB Infections
  Enrolling by invitation · Observational · 300 enrolled · The First Affiliated Hospital with Nanjing Medical University
  NCT06990126updated 2026-01-06
• Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen
  Active not recruiting · Phase 4 · Interventional · 86 enrolled · Air Force Specialized Hospital, Cairo, Egypt
  NCT07258225updated 2025-12-02
• Comparing Oral Versus Parenteral Antimicrobial Therapy
  Terminated · Phase 4 · Interventional · 94 enrolled · West Virginia University
  NCT05977868updated 2025-08-26

Frequently asked questions

How does Tigecycline work?

Tigecycline is a tetracycline class antibacterial [see Microbiology ( 12.4 )] .

What is Tigecycline used for?

According to FDA labeling, Tigecycline carries indications including: Tigecycline for injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: Complicated skin and skin structure infections ( 1.1 ) Complicated intra-abdominal infections ( 1.2 ) Community-acquired bacterial pneumonia ( 1.3 ) Limitations of Use: Tigecycline for injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia ( 1.4 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of tigecycline for injection and other antibacterial drugs, tigecycline for injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria ( 1.5 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tigecycline?

Tigecycline is classified as Tetracyclines, Tetracycline-class Antibacterial, Protein Synthesis Inhibitors, Decreased Mitosis, Decreased Protein Synthesis, Increased Cellular Death.

What are the brand names for Tigecycline?

Tigecycline is marketed under brand names including Tygacil.

What are the contraindications for Tigecycline?

Tigecycline labeling lists contraindications including: Tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline or to any of the excipients. Reactions have included anaphylactic reactions [ see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.2 ) ] .. Always consult the full prescribing information and a clinician.