Prescription medicine

Tigecycline Brand names: Tygacil

Tigecycline (Tygacil) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 4 generic labelers.

Generic listed
Boxed warning

Check it at the source: the tigecycline FDA label on DailyMed (effective November 18, 2025, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.); the NDA 21821 record on Drugs@FDA; every tigecycline label on DailyMed.

Highlights of the record

FDA label of November 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

ALL-CAUSE MORTALITY.

An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in TYGACIL-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. TYGACIL should be reserved for use in situations when alternative treatments are not suitable [see Indications and Usage (1.4), Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ]. WARNING: ALL-CAUSE MORTALITY See full prescribing information for complete boxed warning. All-cause mortality was higher in patients treated with TYGACIL than comparators in a meta-analysis of clinical trials. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. TYGACIL should be reserved for use in situations when alternative treatments are not suitable.

Used for

From the label: indications and usage
TYGACIL 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: TYGACIL is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia ( 1.4

Forms and strengths

50 mg
50 mg/5ml
50 mg/10ml

Injection (powder) (lyophilized) for solution.

On the market

Earliest approval on file: June 15, 2005 Tygacil, Pf Prism Cv; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 5 first May 27, 2015; 4 with a marketed status in Drugs@FDA
Labelers listed (NDC): 6 of which 4 under generic applications, 2 under brand applications, repackagers included
Last listed patent: October 8, 2030 Tygacil injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 6,097 through July 30, 2026

What is tigecycline used for?

From the label: indications and usage
TYGACIL 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: TYGACIL is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia ( 1.4 ). […]

Conditions named in the indications of tigecycline's FDA labels, with every medicine labeled for each:

Bacterial infections

From other tigecycline labels
Bacterial infections: Skin and Skin Structure Infections TYGACIL is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of Escherichia coli, Enterococcus faecalis …

FDA pharmacologic class: Tetracycline-class Antibacterial.

Source: FDA drug label (Tygacil), NDA021821 (Pf Prism Cv), as published by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective November 18, 2025 (SPL set fd826e47-1b77-4ffd-bb22-fda3379903b0), via openFDA; the full label on DailyMed

Is there a generic for tigecycline (Tygacil)?

The FDA approved the first generic tigecycline on May 27, 2015. 5 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists tigecycline from 4 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 6 patents for Tygacil injection, the last expiring on October 8, 2030; a patent listed only for Tigecycline injection runs to April 7, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2005 earliest approval on file
2015 first generic approved
2030 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the tigecycline label say about other medicines?

The tigecycline label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name tigecycline. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Cilastatin and imipenem	warnings and precautions	In cIAI studies (n=1642), 6 patients treated with TYGACIL and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/septic shock.
Cyclosporine	drug interactions	Calcineurin Inhibitors: Serum concentrations of calcineurin inhibitors (e.g., tacrolimus, cyclosporine) should be monitored during treatment with TYGACIL due to risk of toxicity.
Tacrolimus	drug interactions	Calcineurin Inhibitors: Serum concentrations of calcineurin inhibitors (e.g., tacrolimus, cyclosporine) should be monitored during treatment with TYGACIL due to risk of toxicity.
Tetracycline	warnings and precautions	A decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours.
Warfarin	drug interactions	Suitable anticoagulation test should be monitored if TYGACIL is administered to patients receiving warfarin.

Check tigecycline against other medicines

What do FAERS reports show for tigecycline?

The FDA Adverse Event Reporting System holds 6,097 reports that list tigecycline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,633 are coded as a death and 2,441 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)743
Off Label Use (a use or a product term, not a reaction)689
Nausea (named in the label)414
Vomiting (named in the label)280
Sepsis (named in the label)268
Death (an outcome recorded in the report)259
Thrombocytopenia (named in the label)256
Septic Shock (named in the label)232

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as tigecycline?

20 other medicines are given the same way (intravenous) and in the same FDA class as tigecycline or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (intravenous)	Pharmacy cost	Shortage
Vancomycin	Bacterial infections	21 labelers	$2.31 per vial 500 mg vial	A presentation being discontinued
Piperacillin and tazobactam	Bacterial infections	15 labelers	$3.49 per vial 3.375 g vial	A presentation being discontinued
Levofloxacin	Bacterial infections	8 labelers	n/a	No current entry
Clindamycin	Bacterial infections	6 labelers	n/a	In shortage
Ampicillin	Bacterial infections	11 labelers	n/a	A presentation being discontinued
Linezolid	Bacterial infections	9 labelers	n/a	No current entry
Cefoxitin	Bacterial infections	5 labelers	n/a	No current entry
Ampicillin and sulbactam	Bacterial infections	7 labelers	n/a	No current entry

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Other tetracycline-class antibacterials: the pharmacologic class, with prices and generics
Tigecycline side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other