Quick answers
- What is Tigecycline used for?
- The FDA-approved label (Tygacil, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., November 18, 2025) says: “TYGACIL is a tetracycline class antibacterial indicated in patients 18 years of age and older for: • Complicated skin and skin structure infections • Complicated intra-abdominal infections • Community-acquired bacterial pneumonia Limitations of Use: TYGACIL is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tigecycline have a boxed warning?
- Yes. The FDA label for Tygacil has a boxed warning (“WARNING: ALL-CAUSE MORTALITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tigecycline?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tigecycline been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tigecycline?
- 6 companies list prescription products of Tigecycline in the FDA NDC Directory, including Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., Meitheal Pharmaceuticals Inc. and Eugia US LLC.
What Tigecycline is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TYGACIL is a tetracycline class antibacterial indicated in patients 18 years of age and older for: • Complicated skin and skin structure infections • Complicated intra-abdominal infections • Community-acquired bacterial pneumonia Limitations of Use: TYGACIL is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia. …
— FDA label: Tygacil, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective November 18, 2025. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: ALL-CAUSE MORTALITY
. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous · Parenteral |
| Prescription products | 7 in the FDA NDC Directory |
| Brand names | Tygacil |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.2 products
- Meitheal Pharmaceuticals Inc.2 products
- Eugia US LLC1 product
- Apotex Corp.1 product
- Amneal Pharmaceuticals LLC1 product
- Sandoz Inc1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021821 TYGACIL | Pf Prism Cv | June 15, 2005 | 27, latest March 31, 2025 2025: Labeling · 2020: Labeling · 2020: Labeling |
| NDA211158 TIGECYCLINE | Amneal | August 2, 2018 | 4, latest March 31, 2025 2025: Labeling · 2021: Labeling · 2020: Labeling |
Generic approvals (4)
- ANDA091620Sandoz · May 27, 2015
- ANDA204439Apotex · December 21, 2018
- ANDA206335Eugia Pharma · June 11, 2019
- ANDA214020Meitheal · May 13, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 581531, 584201 |
|---|---|
| SPL set ID of the quoted label | fd826e47-1b77-4ffd-bb22-fda3379903b0 |
| FDA labels (SPL) | 8 |
| FDA applications | NDA021821, NDA211158, 4 ANDA |
| Active ingredients (FDA) | TIGECYCLINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tygacil, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective November 18, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →