Tygacil Side Effects

Generic Name: tigecycline

Please note - some side effects for Tygacil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Tygacil - for the Consumer

Tygacil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tygacil:

Diarrhea; dizziness; increased sweating; nausea; pain, swelling, or redness at the injection site; stomach upset; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Tygacil:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; fast or slow heartbeat; fever, chills, or sore throat; sensitivity to light; severe headaches; severe or persistent diarrhea; severe or persistent nausea and vomiting; stomach or back pain with or without nausea or vomiting; swollen, tender stomach; symptoms of liver damage (eg, yellowing of the skin or eyes, pale stools, dark urine, loss of appetite); unusual vaginal itching or discharge; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Tygacil Side Effects - for the Professional

Tygacil

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 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)
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.
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

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. 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

	Tygacil		Comparator		Risk Difference*
Infection Type	n/N	%	n/N	%	% (95% CI)
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).
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)**

In comparative clinical studies, infection-related serious adverse events were more frequently reported for subjects treated with Tygacil (7%) versus comparators (6%). Serious adverse events 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 (5.9)].

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 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 intra-abdominal 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 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 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: 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. 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
• severe skin reactions, including Stevens-Johnson Syndrome

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Side Effects by Body System - for Healthcare Professionals

General

In clinical trials, 2514 patients were treated with tigecycline. In comparative trials, serious side effects related to infection were reported more often in patients treated with tigecycline (7%) versus comparators (6%), with sepsis/septic shock reported in 2% and 1% of patients treated with tigecycline and comparator drugs, respectively. The most common side effects were nausea and vomiting which usually occurred within the first 2 days of treatment. Tigecycline was discontinued due to side effects in 7% of patients (compared to 6% for all comparators). Discontinuation was most often due to nausea (1%) and vomiting (1%) in tigecycline-treated patients and nausea (less than 1%) in comparator-treated patients.

In all 13 Phase 3 and 4 trials that included a comparator, death occurred in 4% and 3% of patients receiving tigecycline and comparator drugs, respectively. The cause of this imbalance has not been determined. In general, deaths resulted from worsening infection, complications of infection, or underlying comorbidities.

Gastrointestinal

The majority of cases of nausea and vomiting were mild to moderate in severity.

Gastrointestinal side effects have included nausea (up to 35%), vomiting (up to 20%), diarrhea (12%), dyspepsia (2%), anorexia (less than 2%), abnormal stools (less than 2%), taste perversion (less than 2%), Clostridium difficile associated diarrhea, pancreatitis, acute pancreatitis (including fatal cases), constipation, and dry mouth. Acute pancreatitis has also been reported during postmarketing experience.

Other

Other side effects have included infection (8%), abdominal pain (6%), abscess (3%), asthenia (3%), sepsis/septic shock (up to 2%), chills (less than 2%), back pain, fever, pain, local reaction to procedure, peripheral edema, and wound infections.

Nervous system

Nervous system side effects have included headache (6%), dizziness (3%), insomnia, and somnolence.

Metabolic

Metabolic side effects have included hypoproteinemia (5%), increased alkaline phosphatase (4%), abnormal healing (4%), increased amylase (3%), hypocalcemia (less than 2%), hypoglycemia (less than 2%), hyponatremia (less than 2%), hyperglycemia, hypokalemia, and increased lactic dehydrogenase.

Hepatic

Hepatic side effects have included increased SGPT (5%), increased SGOT (4%), bilirubinemia (2%), jaundice (less than 2%), hyperbilirubinemia, and increased liver enzymes. Isolated cases of significant hepatic dysfunction and hepatic failure have been reported. Hepatic cholestasis and jaundice have been reported during postmarketing experience.

Hematologic

Hematologic side effects have included anemia (4%), thrombocythemia, and leukocytosis. Prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), and thrombocytopenia have been reported in less than 2% of patients.

Cardiovascular

Cardiovascular side effects have included phlebitis (3%), thrombophlebitis (less than 2%), hypertension, hypotension, bradycardia, tachycardia, and vasodilatation.

Renal

Renal side effects have included increased BUN (3%) and increased creatinine (less than 2%).

Dermatologic

Dermatologic side effects have included rash (3%), pruritus (less than 2%), and sweating. Diffuse cutaneous hyperpigmentation has also been reported.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (less than 2%). Anaphylaxis/anaphylactoid reactions have been reported during postmarketing experience.

Local

Local side effects have included injection site pain, injection site inflammation, injection site reaction, injection site phlebitis, and injection site edema in less than 2% of patients.

Genitourinary

Genitourinary side effects have included vaginal moniliasis, vaginitis, and leukorrhea in less than 2% of patients.

Respiratory

Respiratory system side effects have included increased cough, dyspnea, and pulmonary changes.

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