What the label lists and what reports show
Tigecycline side effects
Tigecycline's FDA label: “The most common adverse reactions (incidence >5%) are nausea, vomiting, diarrhea, abdominal pain, headache, and increased SGPT.” FAERS holds 6,097 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (414 reports).
- 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 FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence >5%) are nausea, vomiting, diarrhea, abdominal pain, headache, and increased SGPT.
Table 1. Incidence (%) of Adverse Reactions Through Test of Cure Reported in ≥ 2% of Patients Treated in Clinical Studies
| Body System Adverse Reactions | TYGACIL (N=2514) | Comparators Vancomycin/Aztreonam, Imipenem/Cilastatin, Levofloxacin, Linezolid. (N=2307) |
|---|---|---|
| Abdominal pain | 6 | 4 |
| Abscess | 2 | 2 |
| Asthenia | 3 | 2 |
| Headache | 6 | 7 |
| Infection | 7 | 5 |
| Phlebitis | 3 | 4 |
| Diarrhea | 12 | 11 |
| Dyspepsia | 2 | 2 |
| Nausea | 26 | 13 |
| Vomiting | 18 | 9 |
| Anemia | 5 | 6 |
| Alkaline Phosphatase Increased | 3 | 3 |
| Amylase Increased | 3 | 2 |
| Bilirubinemia | 2 | 1 |
| BUN Increased | 3 | 1 |
| Healing Abnormal | 3 | 2 |
| Hyponatremia | 2 | 1 |
| Hypoproteinemia | 5 | 3 |
| SGOT Increased LFT abnormalities in TYGACIL-treated patients were reported more… | 4 | 5 |
| SGPT Increased | 5 | 5 |
| Pneumonia | 2 | 2 |
| Dizziness | 3 | 3 |
| Rash | 3 | 4 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 Pfizer Inc. at 1-800-438-1985 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, 2514 patients were treated with TYGACIL. TYGACIL 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. …
Source: FDA drug label, 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
What do FAERS reports show?
6,097 reports list tigecycline among the medicines taken, 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. Of the 17 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tigecycline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions