Tigecycline Side Effects

Some side effects of tigecycline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tigecycline: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking tigecycline: 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 of tigecycline may include:

• dizziness, sleep problems (insomnia);

• headache; or

• 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.

For Healthcare Professionals

Applies to tigecycline: intravenous powder for injection

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. Cases of interstitial or edematous pancreatitis and acute necrotizing pancreatitis have been reported. 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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