Applies to tigecycline: intravenous powder for solution.

Serious side effects of Tigecycline

Along with its needed effects, tigecycline may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking tigecycline:

More common

• Cough or hoarseness
• dizziness
• fever or chills
• headache
• lower back or side pain
• pain, warmth, or burning in the fingers, toes, and legs
• painful or difficult urination
• problems with vision or hearing

Less common

• Abdominal or stomach pain
• accumulation of pus
• bloating or swelling of the face, arms, hands, lower legs, or feet
• changes in skin color
• confusion
• decreased urine
• diarrhea
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fat in the stool
• irregular heartbeat
• muscle pain or cramps
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain
• rapid weight gain
• shortness of breath
• slow or fast heartbeat
• sweating
• swollen, red, tender area of infection
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Rare

• Anxiety
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• chest pain or discomfort
• clay-colored stools
• cold sweats
• dark urine
• depression
• muscle cramps in the hands, arms, feet, legs, or face
• nightmares
• pinpoint red spots on the skin
• rash
• shakiness
• slurred speech
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, ankles, or hands
• swollen glands
• tremor
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Bloating
• constipation
• difficulty with swallowing
• hives
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Other side effects of Tigecycline

Some side effects of tigecycline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Red streaks on the skin
• swelling, tenderness, or pain at the injection site

Less common

• Belching
• heartburn or indigestion
• lack or loss of strength
• stomach discomfort, upset, or pain
• trouble sleeping

Rare

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• change in taste or bad unusual or unpleasant (after) taste
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• sleepiness or unusual drowsiness

For Healthcare Professionals

Applies to tigecycline: intravenous powder for injection.

General

In clinical trials, 2514 patients were treated with this drug. In comparative trials, serious side effects related to infection were reported more often in patients treated with this drug (7%) versus comparators (6%), with sepsis/septic shock reported in 2% and 1% of patients treated with this drug and comparator drugs, respectively. The most common side effects were nausea and vomiting which usually occurred within the first 2 days of therapy and were of mild or moderate severity. This drug 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%) inpatients treated with this drug 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 this drug 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.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 35%), vomiting (up to 20%), diarrhea (12%)

Common (1% to 10%): Abdominal pain, increased amylase, dyspepsia

Frequency not reported: Abnormal stools, Clostridium difficile-associated diarrhea, pseudomembranous colitis, pancreatitis (including interstitial/edematous pancreatitis, acute necrotizing pancreatitis), constipation, dry mouth

Postmarketing reports: Acute pancreatitis^[Ref]

Acute pancreatitis (including fatal cases) has been associated with this drug. Cases have been reported in patients without known risk factors for pancreatitis. In general, patients improved after this drug was stopped.^[Ref]

Other

In a trial of patients with hospital-acquired (including ventilator-associated) pneumonia, patients used this drug or a comparator. In the subgroup of patients with ventilator-associated pneumonia, those who used this drug had lower cure rates (47.9% versus 70.1%) and greater mortality (19.1% versus 12.3% in comparator-treated patients). Patients with ventilator-associated pneumonia and bacteremia at baseline who used this drug had particularly high mortality (50% versus 7.7% in comparator-treated patients).^[Ref]

Common (1% to 10%): Infection, asthenia, increased alkaline phosphatase, abnormal healing, abscess, sepsis/septic shock

Frequency not reported: Chills, death, mortality imbalance, lower cure rates, fever, pain, local reaction to procedure, increased lactic dehydrogenase, peripheral edema, wound infections^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Frequency not reported: Taste perversion, somnolence^[Ref]

Hepatic

Isolated cases of significant hepatic dysfunction and hepatic failure have been reported.

Liver function test abnormalities (e.g., increased ALT and AST) in patients treated with this drug were reported more often posttherapy than those in comparator-treated patients, which were reported more often on therapy.^[Ref]

Common (1% to 10%): Increased ALT, increased AST, bilirubinemia

Frequency not reported: Jaundice, significant hepatic dysfunction, hepatic failure, hyperbilirubinemia, increased liver enzymes, liver function test abnormalities

Postmarketing reports: Hepatic cholestasis, jaundice^[Ref]

Hematologic

Common (1% to 10%): Anemia

Frequency not reported: Prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased INR, thrombocythemia, leukocytosis

Postmarketing reports: Thrombocytopenia, hypofibrinogenemia^[Ref]

Metabolic

Common (1% to 10%): Hypoproteinemia, hyponatremia

Frequency not reported: Hypocalcemia, hypoglycemia, anorexia, hyperglycemia, hypokalemia

Postmarketing reports: Symptomatic hypoglycemia^[Ref]

Symptomatic hypoglycemia was reported in patients with and without diabetes mellitus.^[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Pruritus, sweating, diffuse cutaneous hyperpigmentation

Postmarketing reports: Severe skin reactions (including Stevens-Johnson syndrome)^[Ref]

Cardiovascular

Common (1% to 10%): Phlebitis

Frequency not reported: Thrombophlebitis, hypertension, hypotension, bradycardia, tachycardia, vasodilatation^[Ref]

Renal

Common (1% to 10%): Increased BUN/serum urea

Frequency not reported: Increased creatinine^[Ref]

Respiratory

Common (1% to 10%): Pneumonia

Frequency not reported: Increased cough, dyspnea, pulmonary changes^[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction

Postmarketing reports: Anaphylactic reactions

Local

Frequency not reported: Injection site pain, injection site inflammation, injection site reaction, injection site phlebitis, injection site edema^[Ref]

Genitourinary

Frequency not reported: Vaginal moniliasis, vaginitis, leukorrhea^[Ref]

Musculoskeletal

Frequency not reported: Back pain

Psychiatric

Frequency not reported: Insomnia