Tygacil
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Tygacil
Tygacil Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tygacil (tigecycline) is used to treat many different bacterial infections of the skin or the digestive system. It is a tetracycline-like antibiotic. Common side effects include nausea, vomiting, headache, dizziness, or pain/swelling at the injection site.
The recommended dosage regimen for Tygacil is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous infusions should be administered over approximately 30 to 60 minutes every 12 hours. Tygacil may interact with amphotericin B, chlorpromazine, methylprednisolone, or voriconazole. Tell your doctor all medications you are taking. Tygacil is not recommended for use during pregnancy because of possible harm to a fetus. Women of child-bearing age should use effective birth control while using this medication. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Tygacil (tigecycline) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Tygacil in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using tigecycline and call your doctor at once if you have a serious side effect such as:
- diarrhea that is watery or bloody;
- severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.
Less serious side effects may include:
- headache; or
- dizziness, sleep problems (insomnia);
- vaginal itching or discharge.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Tygacil (Tigecycline) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Tygacil Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: sunburn (sun sensitivity), change in the amount of urine, unusual fatigue, severe stomach/abdominal pain, hearing changes (e.g., ringing in the ears, decreased hearing), persistent or severe headache, vision changes (e.g., blurred vision, double vision), irregular heartbeat, easy bleeding/bruising, yellowing of the eyes or skin, dark urine.
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool.
Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.
A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Tygacil (Tigecycline)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tygacil FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
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 (tigecycline) . TYGACIL (tigecycline) was discontinued due to adverse reactions in 7% of patients compared to 6% for all comparators. Table 1 shows the incidence of treatment-emergent 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 Adverse Reactions |
TYGACIL (N=2514) |
Comparatorsa (N=2307) |
| Body as a Whole | ||
| Abdominal pain | 6 | 4 |
| Abscess | 3 | 3 |
| Asthenia | 3 | 2 |
| Headache | 6 | 7 |
| Infection | 8 | 5 |
| Cardiovascular System | ||
| Phlebitis | 3 | 4 |
| Digestive System | ||
| Diarrhea | 12 | 11 |
| Dyspepsia | 2 | 2 |
| Nausea | 26 | 13 |
| Vomiting | 18 | 9 |
| Hemic and Lymphatic System | ||
| Anemia | 4 | 5 |
| Metabolic and Nutritional | ||
| Alkaline Phosphatase | 4 | 3 |
| Increased | ||
| Amylase Increased | 3 | 2 |
| Bilirubinemia | 2 | 1 |
| BUN Increased | 3 | 1 |
| Healing Abnormal | 4 | 3 |
| Hypoproteinemia | 5 | 3 |
| SCOT Increasedb | 4 | 5 |
| SGPT Increasedb | 5 | 5 |
| Nervous System | ||
| Dizziness | 3 | 3 |
| Skin and Appendages | ||
| Rash | 3 | 4 |
| a Vancomycin/Aztreonam, Imipenem/Cilastatin, Levofloxacin,
Linezolid. b LFT abnormalities in TYGACIL (tigecycline) -treated patients were reported more frequently in the post therapy period than those in comparator-treated patients, which occurred more often on therapy. |
||
In all 13 Phase 3 and 4 trials that included a comparator, death occurred in 4.0% (150/3788) of patients receiving TYGACIL (tigecycline) and 3.0% (110/3646) of patients receiving comparator drugs. In a pooled analysis of these trials, based on a random effects model by trial weight, an adjusted risk difference of all-cause mortality was 0.6% (95% CI 0.1, 1.2) between TYGACIL (tigecycline) and comparator-treated patients (see Table 2). The cause of the imbalance has not been established. Generally, deaths were the result of worsening infection, complications of infection or underlying co-morbidities.
Table 2. Patients with Outcome of Death bv Infection Tvne
| Infection Type | TYGACIL n/N |
% | Comparator n/N |
% | Risk Difference* % (95% CI) |
| cSSSI | 12/834 | 1.4 | 6/813 | 0.7 | 0.7 (-0.3, 1.7) |
| cIAI | 42/1382 | 3.0 | 31/1393 | 2.2 | 0.8 (-0.4, 2.0) |
| CAP | 12/424 | 2.8 | 11/422 | 2.6 | 0.2 (-2.0, 2.4) |
| HAP | 66/467 | 14.1 | 57/467 | 12.2 | 1.9 (-2.4, 6.3) |
| Non-VAPa | 41/336 | 12.2 | 42/345 | 12.2 | 0.0 (-4.9, 4.9) |
| VAPa | 25/131 | 19.1 | 15/122 | 12.3 | 6.8 (-2.1, 15.7) |
| RP | 11/128 | 8.6 | 2/43 | 4.7 | 3.9 (-4.0, 11.9) |
| DPI | 7/553 | 1.3 | 3/508 | 0.6 | 0.7 (-0.5, 1.8) |
| Overall Adjusted | 150/3788 | 4.0 | 110/3646 | 3.0 | 0.6 (0.1, 1.2)** |
| CAP = Community-acquired pneumonia; cIAI = Complicated intra-abdominal
infections; cSSSI = Complicated skin and skin structure infections; HAP
= Hospital-acquired pneumonia; VAP = Ventilator-associated pneumonia; RP
= Resistant pathogens; DPI = Diabetic foot infections. * The difference between the percentage of patients who died in TYGACIL (tigecycline) and comparator treatment groups. The 95% CI for each infection type was calculated using the normal approximation method without continuity correction. ** Overall adjusted (random effects model by trial weight) risk difference estimate and 95% CI. a These are subgroups of the HAP population. Note: The studies include 300, 305, 900 (cSSSI), 301, 306, 315, 316, 400 (cIAI), 308 and 313 (CAP), 311 (HAP), 307 [Resistant gram-positive pathogen study in patients with MRS A or Vancomycin-Resistant Enterococcus (VRE)], and 319 (DPI with and without osteomyelitis). |
|||||
In comparative clinical studies, infection-related serious adverse events were more frequently reported for subjects treated with TYGACIL (tigecycline) (7%) versus comparators (6%). Serious adverse events of sepsis/septic shock were more frequently reported for subjects treated with TYGACIL (tigecycline) (2%) versus comparators (1%). Due to baseline differences between treatment groups in this subset of patients, the relationship of this outcome to treatment cannot be established [see WARNINGS AND PRECAUTIONS].
The most common treatment-emergent adverse reactions were nausea and vomiting which generally occurred during the first 1-2 days of therapy. The majority of cases of nausea and vomiting associated with TYGACIL (tigecycline) and comparators were either mild or moderate in severity. In patients treated with TYGACIL (tigecycline) , nausea incidence was 26% (17% mild, 8% moderate, 1% severe) and vomiting incidence was 18% (11% mild, 6% moderate, 1% severe).
In patients treated for complicated skin and skin structure infections (cSSSI), nausea incidence was 35% for TYGACIL (tigecycline) and 9% for vancomycin/aztreonam; vomiting incidence was 20% for TYGACIL (tigecycline) and 4% for vancomycin/aztreonam. In patients treated for complicated intra-abdominal infections (cIAI), nausea incidence was 25% for TYGACIL (tigecycline) and 21% for imipenem/cilastatin; vomiting incidence was 20% for TYGACIL (tigecycline) and 15% for imipenem/cilastatin. In patients treated for community-acquired bacterial pneumonia (CABP), nausea incidence was 24% for TYGACIL (tigecycline) and 8% for levofloxacin; vomiting incidence was 16% for TYGACIL (tigecycline) and 6% for levofloxacin.
Discontinuation from tigecycline was most frequently associated with nausea (1%) and vomiting (1%). For comparators, discontinuation was most frequently associated with nausea ( < 1%).
The following adverse reactions were reported infrequently ( < 2%) in patients receiving TYGACIL (tigecycline) in clinical studies:
Body as a Whole: injection site inflammation, injection site pain, injection site reaction, septic shock, allergic reaction, chills, injection site edema, injection site phlebitis
Cardiovascular System: thrombophlebitis
Digestive System: anorexia, jaundice, abnormal stools
Metabolic/Nutritional System: increased creatinine, hypocalcemia, hypoglycemia, hyponatremia
Special Senses: taste perversion
Hemic and Lymphatic System: partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia
Skin and Appendages: pruritus
Urogenital System: vaginal moniliasis, vaginitis, leukorrhea
Post-Marketing Experience
The following adverse reactions have been identified during postapproval use of TYGACIL (tigecycline) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.
- anaphylaxis/anaphylactoid reactions
- acute pancreatitis
- hepatic cholestasis, and jaundice
Read the entire FDA prescribing information for Tygacil (Tigecycline) »
Additional Tygacil Information
Tygacil - User Reviews
Tygacil User Reviews
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Report Problems to the Food and Drug Administration
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