Tygacil
- Generic Name: tigecycline
- Brand Name: Tygacil
- Drug Class: Glycylcyclines
Tygacil (Tigecycline) side effects drug center
Tygacil Side Effects Center
What Is Tygacil?
Tygacil (tigecycline) is a tetracycline-like antibiotic used to treat many different bacterial infections of the skin or the digestive system.
What Are Side Effects of Tygacil?
Common side effects of Tygacil include:
- nausea,
- vomiting,
- headache,
- dizziness,
- sleep problems (insomnia),
- pain or swelling at the injection site, or
- vaginal itching or discharge.
Tell your doctor if you have serious side effects of Tygacil including:
- sunburn (sun sensitivity),
- changes in the amount of urine,
- unusual fatigue,
- severe stomach or abdominal pain,
- hearing changes (e.g., ringing in the ears, decreased hearing),
- irregular heartbeat,
- easy bleeding or bruising,
- yellowing of the eyes or skin, or
- dark urine.
Dosage for Tygacil
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.
What Drugs, Substances, or Supplements Interact with Tygacil?
Tygacil may interact with amphotericin B, chlorpromazine, methylprednisolone, or voriconazole. Tell your doctor all medications you are taking.
Tygacil During Pregnancy and Breastfeeding
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 breastfeeding.
Additional Information
Our Tygacil (tigecycline) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Tygacil Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe stomach pain, diarrhea that is watery or bloody;
- increased pressure inside the brain--severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;
- pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
- liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- nausea, vomiting, stomach pain;
- diarrhea;
- headache; or
- abnormal liver function tests.
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)
Tygacil Professional Information
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
- All-Cause Mortality [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Mortality Imbalance and Lower Cure Rates in Hospital-Acquired Pneumonia [see WARNINGS AND PRECAUTIONS]
- Anaphylaxis [WARNINGS AND PRECAUTIONS]
- Hepatic Adverse Effects [WARNINGS AND PRECAUTIONS]
- Pancreatitis [WARNINGS AND PRECAUTIONS]
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: 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 | 2 | 2 |
| Asthenia | 3 | 2 |
| Headache | 6 | 7 |
| Infection | 7 | 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 | 5 | 6 |
| Metabolic and Nutritional | ||
| Alkaline Phosphatase | 3 | 3 |
| Increased | ||
| Amylase Increased | 3 | 2 |
| Bilirubinemia | 2 | 1 |
| BUN Increased | 3 | 1 |
| Healing Abnormal | 3 | 2 |
| Hyponatremia | 2 | 1 |
| Hypoproteinemia | 5 | 3 |
| SGOT Increasedb | 4 | 5 |
| SGPT Increasedb | 5 | 5 |
| Respiratory System | ||
| Pneumonia | 2 | 2 |
| Nervous System | ||
| Dizziness | 3 | 3 |
| Skin and Appendages | ||
| Rash | 3 | 4 |
| a Vancomycin/Aztreonam, Imipenem/Cilastatin, Levofloxacin, Linezolid. b LFT abnormalities in TYGACIL-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 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 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 by Infection Type
| Infection Type | TYGACIL | Comparator | Risk Difference* % (95% CI) | ||
| n/N | % | n/N | % | ||
| 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) |
| DFI | 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; DFI = Diabetic foot infections. * The difference between the percentage of patients who died in TYGACIL 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 MRSA or Vancomycin-Resistant Enterococcus (VRE)], and 319 (DFI with and without osteomyelitis). | |||||
An analysis of mortality in all trials conducted for approved indications - cSSSI, cIAI, and CABP, including post-market trials (one in cSSSI and two in cIAI) - showed an adjusted mortality rate of 2.5% (66/2640) for tigecycline and 1.8% (48/2628) for comparator, respectively. The adjusted risk difference for mortality stratified by trial weight was 0.6% (95% CI 0.0, 1.2).
In comparative clinical studies, infection-related serious adverse reactions were more frequently reported for subjects treated with TYGACIL (7%) versus comparators (6%). Serious adverse reactions of sepsis/septic shock were more frequently reported for subjects treated with TYGACIL (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 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 and comparators were either mild or moderate in severity. In patients treated with TYGACIL, 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 and 9% for vancomycin/aztreonam; vomiting incidence was 20% for TYGACIL and 4% for vancomycin/aztreonam. In patients treated for complicated intraabdominal infections (cIAI), nausea incidence was 25% for TYGACIL and 21% for imipenem/cilastatin; vomiting incidence was 20% for TYGACIL and 15% for imipenem/cilastatin. In patients treated for community-acquired bacterial pneumonia (CABP), nausea incidence was 24% for TYGACIL and 8% for levofloxacin; vomiting incidence was 16% for TYGACIL and 6% for levofloxacin.
Discontinuation from TYGACIL 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 (<2%) in patients receiving TYGACIL 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
Special Senses: taste perversion
Hemic and Lymphatic System: prolonged activated 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 post-approval use of TYGACIL. 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.
- anaphylactic reactions
- acute pancreatitis
- hepatic cholestasis, and jaundice
- severe skin reactions, including Stevens-Johnson Syndrome
- symptomatic hypoglycemia in patients with and without diabetes mellitus
- hypofibrinogenemia [see WARNINGS AND PRECAUTIONS]
Read the entire FDA prescribing information for Tygacil (Tigecycline)
&Copy; Tygacil Patient Information is supplied by Cerner Multum, Inc. and Tygacil Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.