Tygacil Side Effects

Generic Name: tigecycline

Note: This page contains side effects data for the generic drug tigecycline. It is possible that some of the dosage forms included below may not apply to the brand name Tygacil.

It is possible that some side effects of Tygacil may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to tigecycline: intravenous powder for solution

As well as its needed effects, tigecycline (the active ingredient contained in Tygacil) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking tigecycline, check with your doctor or nurse immediately:

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

Some tigecycline side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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 tigecycline (the active ingredient contained in Tygacil) 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.[Ref]

Gastrointestinal

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

Very common (10% or more): Nausea (up to 35%), vomiting (up to 20%), diarrhea (12%)
Common (1% to 10%): Dyspepsia (2%), anorexia (less than 2%), abnormal stools (less than 2%), taste perversion (less than 2%)
Frequency not reported: Clostridium difficile associated diarrhea, pancreatitis, acute pancreatitis (including fatal cases), constipation, dry mouth, interstitial or edematous pancreatitis, acute necrotizing pancreatitis
Postmarketing reports: Acute pancreatitis[Ref]

Other

Common (1% to 10%): Infection (7%), abdominal pain (6%), asthenia (3%), abscess (2%), sepsis/septic shock (up to 2%), chills (less than 2%)
Frequency not reported: Back pain, fever, pain, local reaction to procedure, peripheral edema, wound infections[Ref]

Nervous system

Common (1% to 10%): Headache (6%), dizziness (3%)
Frequency not reported: Insomnia, somnolence[Ref]

Hepatic

Common (1% to 10%): Increased SGPT (5%), increased SGOT (4%), bilirubinemia (2%), jaundice (less than 2%)
Rare (less than 0.1%): Significant hepatic dysfunction, hepatic failure
Frequency not reported: Hyperbilirubinemia, increased liver enzymes
Postmarketing reports: Hepatic cholestasis, jaundice[Ref]

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

Hematologic

Common (1% to 10%): Anemia (5%); Less than 2%: Prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia
Frequency not reported: Thrombocythemia, leukocytosis[Ref]

Metabolic

Common (1% to 10%): Hypoproteinemia (5%), increased alkaline phosphatase (3%), abnormal healing (3%), increased amylase (3%), hyponatremia (2%), hypocalcemia (less than 2%), hypoglycemia (less than 2%)
Frequency not reported: Hyperglycemia, hypokalemia, increased lactic dehydrogenase
Postmarketing reports: Symptomatic hypoglycemia[Ref]

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

Dermatologic

Common (1% to 10%): Rash (3%), pruritus (less than 2%)
Frequency not reported: Sweating, diffuse cutaneous hyperpigmentation
Postmarketing reports: Severe skin reactions (including Stevens-Johnson syndrome)[Ref]

Cardiovascular

Common (1% to 10%): Phlebitis (3%), thrombophlebitis (less than 2%)
Frequency not reported: Hypertension, hypotension, bradycardia, tachycardia, vasodilatation[Ref]

Renal

Common (1% to 10%): Increased BUN (3%), increased creatinine (less than 2%)[Ref]

Respiratory

Common (1% to 10%): Pneumonia (2%)
Frequency not reported: Increased cough, dyspnea, pulmonary changes[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction (less than 2%)
Postmarketing reports: Anaphylaxis/anaphylactoid reactions

Local

Common (1% to 10%): Less than 2%: Injection site pain, injection site inflammation, injection site reaction, injection site phlebitis, injection site edema[Ref]

Genitourinary

Common (1% to 10%): Less than 2%: Vaginal moniliasis, vaginitis, leukorrhea[Ref]

References

1. "Product Information. Tygacil (tigecycline)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

2. Mascarello M, Papa G, Arnez ZM, Luzzati R "Acute necrotizing pancreatitis related to tigecycline." J Antimicrob Chemother 67 (2012): 1296-7

3. Yahav D, Lador A, Paul M, Leibovici L "Efficacy and safety of tigecycline: a systematic review and meta-analysis." J Antimicrob Chemother 66 (2011): 1963-71

4. Townsend ML, Pound MW, Drew RH "Tigecycline in the treatment of complicated intra-abdominal and complicated skin and skin structure infections." Ther Clin Risk Manag 3 (2007): 1059-70

5. Slover CM, Rodvold KA, Danziger LH "Tigecycline: a novel broad-spectrum antimicrobial." Ann Pharmacother 41 (2007): 965-72

6. Knueppel RC, Rahimian J "Diffuse cutaneous hyperpigmentation due to tigecycline or polymyxin B." Clin Infect Dis 45 (2007): 136-8

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