Tygacil Side Effects
Generic name: tigecycline
Medically reviewed by Drugs.com. Last updated on Oct 20, 2023.
Note: This document contains side effect information about tigecycline. Some dosage forms listed on this page may not apply to the brand name Tygacil.
Applies to tigecycline: intravenous powder for solution.
Intravenous route (Powder for Solution)
An increase in all-cause mortality was observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI, 0.1 to 1.2) has not been established. Tigecycline should be reserved for use in situations when alternative treatments are not suitable.
Serious side effects of Tygacil
Along with its needed effects, tigecycline (the active ingredient contained in Tygacil) 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:
- Cough or hoarseness
- fever or chills
- lower back or side pain
- pain, warmth, or burning in the fingers, toes, and legs
- painful or difficult urination
- problems with vision or hearing
- Abdominal or stomach pain
- accumulation of pus
- bloating or swelling of the face, arms, hands, lower legs, or feet
- changes in skin color
- decreased urine
- 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
- numbness or tingling in the hands, feet, or lips
- rapid weight gain
- shortness of breath
- slow or fast heartbeat
- 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
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- chest pain or discomfort
- clay-colored stools
- cold sweats
- dark urine
- muscle cramps in the hands, arms, feet, legs, or face
- pinpoint red spots on the skin
- slurred speech
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the face, ankles, or hands
- swollen glands
- unpleasant breath odor
- vomiting of blood
- yellow eyes or skin
Incidence not known
- difficulty with swallowing
- 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 Tygacil
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:
- Red streaks on the skin
- swelling, tenderness, or pain at the injection site
- heartburn or indigestion
- lack or loss of strength
- stomach discomfort, upset, or pain
- trouble sleeping
- 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.
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]
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]
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]
Common (1% to 10%): Headache, dizziness
Frequency not reported: Taste perversion, somnolence[Ref]
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]
Common (1% to 10%): Anemia
Frequency not reported: Prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased INR, thrombocythemia, leukocytosis
Common (1% to 10%): Hypoproteinemia, hyponatremia
Postmarketing reports: Symptomatic hypoglycemia[Ref]
Common (1% to 10%): Rash
Frequency not reported: Pruritus, sweating, diffuse cutaneous hyperpigmentation
Common (1% to 10%): Phlebitis
Common (1% to 10%): Increased BUN/serum urea
Frequency not reported: Increased creatinine[Ref]
Common (1% to 10%): Pneumonia
Frequency not reported: Increased cough, dyspnea, pulmonary changes[Ref]
Frequency not reported: Allergic reaction
Postmarketing reports: Anaphylactic reactions
Frequency not reported: Injection site pain, injection site inflammation, injection site reaction, injection site phlebitis, injection site edema[Ref]
Frequency not reported: Vaginal moniliasis, vaginitis, leukorrhea[Ref]
Frequency not reported: Back pain
Frequency not reported: Insomnia
More about Tygacil (tigecycline)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Dosage information
- During pregnancy
- Generic availability
- FDA approval history
- Drug class: glycylcyclines
- En español
Related treatment guides
1. Product Information. Tygacil (tigecycline). Wyeth-Ayerst Laboratories. 2005.
2. Cerner Multum, Inc. UK Summary of Product Characteristics.
3. Cerner Multum, Inc. Australian Product Information.
4. Slover CM, Rodvold KA, Danziger LH. Tigecycline: a novel broad-spectrum antimicrobial. Ann Pharmacother. 2007;41:965-72.
5. 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. 2007;3:1059-70.
6. Yahav D, Lador A, Paul M, Leibovici L. Efficacy and safety of tigecycline: a systematic review and meta-analysis. J Antimicrob Chemother. 2011;66:1963-71.
7. Mascarello M, Papa G, Arnez ZM, Luzzati R. Acute necrotizing pancreatitis related to tigecycline. J Antimicrob Chemother. 2012;67:1296-7.
8. Knueppel RC, Rahimian J. Diffuse cutaneous hyperpigmentation due to tigecycline or polymyxin B. Clin Infect Dis. 2007;45:136-8.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.