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Glycylcycline — MDR Gram-Negative / Polymicrobial / Complicated Intra-abdominal Pregnancy: eMC §4.6: there are no or limited data from the use of tigecycline in pregnant women, and animal studies have shown reproductive toxicity; the potential risk for humans is unknown. As with tetracycline class antibiotics, tigecycline may induce permanent dental defects (discolouration and enamel defects) and a delay in ossification in foetuses exposed in utero during the last half of gestation, and in children under eight years of age. Tigecycline should NOT be used during pregnancy unless the clinical condition of the woman requires treatment with it. Breast-feeding: it is unknown whether tigecycline or its metabolites are excreted in human milk; animal data show excretion in milk and a risk to the newborn/infant cannot be excluded, so a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tigecycline therapy. Fertility: not studied in humans; nonclinical rat studies do not indicate harmful effects on fertility or reproductive performance.

Tigecycline

Brand names: Tygacil

Tigecycline is a glycylcycline antibacterial reserved for complicated skin and intra-abdominal infections when other antibiotics are unsuitable, with activity against many multidrug-resistant Gram-positive and Gram-negative organisms.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: An initial dose of 100 mg, followed by 50 mg every 12 hours for 5 to 14 days
Route: Intravenous infusion only, over 30 to 60 minutes
Frequency: 50 mg every 12 hours after the 100 mg initial dose, for 5 to 14 days
eMC §4.2 (Tigecycline 50 mg powder for solution for infusion). The duration of therapy should be guided by the severity, the site of the infection, and the patient's clinical response. SEVERE HEPATIC IMPAIRMENT: no dosage adjustment is warranted in mild to moderate hepatic impairment (Child-Pugh A and B), but in patients with severe hepatic impairment (Child-Pugh C), including paediatric patients, the dose of tigecycline should be REDUCED BY 50% - the adult dose should be reduced to 25 mg every 12 hours following the 100 mg loading dose, and these patients should be treated with caution and monitored for treatment response. ELDERLY: no dosage adjustment is necessary. ADMINISTRATION: tigecycline is administered ONLY by intravenous infusion over 30 to 60 minutes, and preferably over a 60-minute infusion in paediatric patients; see SPC §6.6 for reconstitution and dilution. MORTALITY SIGNAL (§4.4): in clinical studies in complicated skin and soft tissue infections, complicated intra-abdominal infections, diabetic foot infections, nosocomial pneumonia, and studies in resistant pathogens, a numerically higher mortality rate was observed among tigecycline-treated patients compared with the comparator treatment; the causes remain unknown but poorer efficacy and safety than the comparators cannot be ruled out. Other §4.4 cautions: superinfection (including impaired surgical wound healing in complicated intra-abdominal infection patients, and poorer outcomes with nosocomial pneumonia superinfection); potentially life-threatening anaphylaxis/anaphylactoid reactions; cases of predominantly cholestatic liver injury including hepatic failure with fatal outcome; tetracycline class effects (photosensitivity, pseudotumor cerebri, pancreatitis, anti-anabolic action causing increased BUN, azotaemia, acidosis and hyperphosphataemia); acute pancreatitis, which can be serious, most reported cases developing after at least one week of treatment; and prolongation of both prothrombin time and activated partial thromboplastin time. PAEDIATRIC: tigecycline should NOT be used in children aged under 8 years because of teeth discolouration, and safety and efficacy under 8 years have not been established.

Paediatric dose

Dose: 1.2 mg/kg
Route: Intravenous infusion, preferably administered over a 60-minute length of infusion in paediatric patients
Frequency: Every 12 hours for 5 to 14 days (children aged 8 to under 12 years)
Max: 50 mg every 12 hours
eMC §4.2, children and adolescents 8 to 17 years of age. CHILDREN AGED 8 TO UNDER 12 YEARS: 1.2 mg/kg of tigecycline every 12 hours intravenously, to a maximum dose of 50 mg every 12 hours, for 5 to 14 days. ADOLESCENTS AGED 12 TO UNDER 18 YEARS: 50 mg of tigecycline every 12 hours for 5 to 14 days - a FIXED dose, not a per-kg dose. TIGECYCLINE SHOULD NOT BE USED IN CHILDREN AGED UNDER 8 YEARS because of teeth discolouration, and safety and efficacy in children under 8 years have not been established (no data available). In paediatric patients with severe hepatic impairment (Child-Pugh C) the dose should be reduced by 50%. Tigecycline may be associated with permanent tooth discolouration if used during tooth development. Verify all under-18 dosing against a children's formulary before prescribing.

Dose adjustments

Renal

eMC §4.2: no dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Paediatric weight-based calculator

eMC §4.2, children and adolescents 8 to 17 years of age. CHILDREN AGED 8 TO UNDER 12 YEARS: 1.2 mg/kg of tigecycline every 12 hours intravenously, to a maximum dose of 50 mg every 12 hours, for 5 to 14 days. ADOLESCENTS AGED 12 TO UNDER 18 YEARS: 50 mg of tigecycline every 12 hours for 5 to 14 days - a FIXED dose, not a per-kg dose. TIGECYCLINE SHOULD NOT BE USED IN CHILDREN AGED UNDER 8 YEARS because of teeth discolouration, and safety and efficacy in children under 8 years have not been established (no data available). In paediatric patients with severe hepatic impairment (Child-Pugh C) the dose should be reduced by 50%. Tigecycline may be associated with permanent tooth discolouration if used during tooth development. Verify all under-18 dosing against a children's formulary before prescribing.

Verify in a children's formulary

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients (§4.3)
  • §4.3 also notes that patients hypersensitive to tetracycline class antibiotics may be hypersensitive to tigecycline

Side effects

  • Very common: nausea (21%) and vomiting (13%), which usually occurred early (treatment days 1-2) and were generally mild or moderate; diarrhoea
  • Common: abdominal pain, dyspepsia, anorexia; headache, dizziness; prolonged activated partial thromboplastin time (aPTT) and prolonged prothrombin time (PT); hypoglycaemia, hypoproteinaemia
  • Common: elevated AST and ALT, hyperbilirubinaemia; elevated serum amylase, increased blood urea nitrogen; pruritus and rash
  • Common: impaired healing, injection site reaction; phlebitis; uncommon injection site inflammation, pain, oedema and phlebitis, and thrombophlebitis
  • Uncommon: thrombocytopenia, increased INR; jaundice, cholestatic liver injury; acute pancreatitis; sepsis/septic shock, pneumonia, abscess and infections. Post-marketing (frequency not known): anaphylaxis/anaphylactoid reactions, hepatic failure, severe skin reactions including Stevens-Johnson syndrome, hypofibrinogenaemia, pseudomembranous colitis, and permanent tooth discolouration if used during tooth development

Interactions

  • Warfarin (US labelling §7.1) - prothrombin time or another suitable anticoagulation test should be monitored if tigecycline is administered with warfarin
  • Calcineurin inhibitors such as tacrolimus or ciclosporin (US labelling §7.2) - concomitant use may lead to an increase in serum trough concentrations of the calcineurin inhibitor, so serum concentrations should be monitored during tigecycline treatment to avoid drug toxicity
  • Oral contraceptives (US labelling §7.3) - concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective
  • The eMC §4.5 interaction section was not captured in this bundle; the entries above come from US labelling (Tigecycline, Apotex Corp) and must be verified against the UK SPC

Clinical monograph

How it works

It binds the 30S ribosomal subunit and blocks entry of aminoacyl-tRNA, inhibiting bacterial protein synthesis and overcoming common tetracycline-resistance mechanisms.

Prescribing in practice

  • An observed increase in all-cause mortality means it should be reserved for situations where alternative antibacterials are not suitable.
  • It has poor serum concentrations and is not recommended for bloodstream infections, and it lacks reliable activity against Pseudomonas and Proteus species.
  • As a tetracycline-related drug it should be avoided in pregnancy and in children with developing teeth, and it commonly causes nausea and vomiting.

Monitoring

Monitor clinical response, liver function and for gastrointestinal intolerance during the parenteral course.

Counselling the patient

  • It is given by infusion, usually in hospital under specialist supervision.
  • Nausea and vomiting are common, especially early in treatment.
  • This is a reserve antibiotic used when other options are not appropriate.

Evidence & guidelines

The MHRA and pooled trial analyses have highlighted higher mortality with tigecycline, restricting it to use when alternatives are unsuitable.

Reference: MHRA Drug Safety Update 2013 (Tigecycline Mortality); FDA Safety Communication; IDSA MDR Organism Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.