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Tigecycline Generic

  • Generic Name: tigecycline
  • Brand Name: Tigecycline Generic Injection

Tigecycline Generic Injection (tigecycline) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

Tigecycline Generic Side Effects Center

Tigecycline for injection 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, and community-acquired bacterial pneumonia. Tigecycline is available in generic form. Common side effects of tigecycline include:

The initial dose of tigecycline is 100 mg, followed by 50 mg every 12 hours administered intravenously over approximately 30 to 60 minutes. Tigecycline may interact with warfarin and oral contraceptives. Tell your doctor all medications and supplements you use. Tigecycline is not recommended for use during pregnancy; it may harm a fetus. Tigecycline may make oral contraceptives less effective. Talk to your doctor about birth control while taking tigecycline. It is unknown if Tigecycline passes into breast milk. Consult your doctor before breastfeeding.

Our Tigecycline for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Tigecycline Generic 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 Tigecycline Generic (tigecycline)

 

Tigecycline Generic Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

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, 2,514 patients were treated with tigecycline. Tigecycline 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 Tigecycline Comparatorsa
Adverse Reactions (N=2,514) (N=2,307)
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 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 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 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% (150/3,788) of patients receiving tigecycline and 3.0% (110/3,646) 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 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 by Infection Type

Infection Type Tigecycline Comparator Risk Difference*
n/N % n/N % % (95% CI)
cSSSI 12/834 1.4 6/813 0.7 0.7
(-0.3, 1.7)
cIAI 42/1,382 3.0 31/1,393 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 150/3,788 4.0 110/3,646 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 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 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% (66/2,640) for tigecycline and 1.8% (48/2,628) 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 tigecycline (7%) versus comparators (6%). Serious adverse reactions of sepsis/septic shock were more frequently reported for subjects treated with 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 adverse reactions were nausea and vomiting which generally occurred during the first 1 to 2 days of therapy. The majority of cases of nausea and vomiting associated with tigecycline and comparators were either mild or moderate in severity. In patients treated with 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 tigecycline and 9% for vancomycin/aztreonam; vomiting incidence was 20% for tigecycline and 4% for vancomycin/aztreonam. In patients treated for complicated intra-abdominal infections (cIAI), nausea incidence was 25% for tigecycline and 21% for imipenem/cilastatin; vomiting incidence was 20% for tigecycline and 15% for imipenem/cilastatin. In patients treated for community-acquired bacterial pneumonia (CABP), nausea incidence was 24% for tigecycline and 8% for levofloxacin; vomiting incidence was 16% for 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 (< 2%) in patients receiving 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

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 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.

  • anaphylactic reactions
  • acute pancreatitis
  • hepatic cholestasis, and jaundice
  • severe skin reactions, including Stevens-Johnson Syndrome
  • symptomatic hypoglycemia in patients with and without diabetes mellitus

Read the entire FDA prescribing information for Tigecycline Generic (tigecycline)

&Copy; Tigecycline Generic Patient Information is supplied by Cerner Multum, Inc. and Tigecycline Generic Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.