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Sivextro Side Effects

Generic Name: tedizolid

Note: This document contains side effect information about tedizolid. Some of the dosage forms listed on this page may not apply to the brand name Sivextro.

In Summary

More frequent side effects include: diarrhea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tedizolid: oral tablet

Along with its needed effects, tedizolid (the active ingredient contained in Sivextro) 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 immediately if any of the following side effects occur while taking tedizolid:

Less common or rare
  • Abdominal or stomach tenderness
  • back pain
  • blurred vision
  • chest tightness
  • chills
  • dizziness
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • headache
  • hives or welts, itching, or skin rash
  • hoarseness
  • joint pain, stiffness, or swelling
  • nausea and vomiting
  • nervousness
  • pale skin
  • pounding in the ears
  • redness of the skin
  • severe abdominal or stomach cramps and pain
  • slow or fast heartbeat
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • watery or severe diarrhea, which may also be bloody

Some side effects of tedizolid 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:

Less common
  • Burning, numbness, tingling, or painful sensations
  • diarrhea
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet
Less common or rare
  • Blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in vision
  • feeling of warmth
  • redness of the face, neck, arms, and occasionally, upper chest
  • seeing floating spots before the eyes
  • sore mouth or tongue
  • trouble sleeping
  • white patches in the mouth or on the tongue

For Healthcare Professionals

Applies to tedizolid: intravenous powder for injection, oral tablet

General

The most common side effects were nausea, headache, diarrhea, vomiting, and dizziness. Median time to onset was 5 days.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, vomiting
Uncommon (0.1% to 1%): Clostridium difficile colitis, oral candidiasis, abdominal pain, constipation, abdominal discomfort, dry mouth, dyspepsia, upper abdominal pain, flatulence, gastroesophageal reflux disease, hematochezia, retching[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, peripheral neuropathy
Uncommon (0.1% to 1%): Somnolence, dysgeusia, tremor, hypoesthesia, paresthesia
Frequency not reported: VIIth nerve paralysis[Ref]

Hematologic

Common (1% to 10%): Decreased hemoglobin, decreased platelet count
Uncommon (0.1% to 1%): Decreased absolute neutrophil count, lymphadenopathy, decreased WBC count
Frequency not reported: Anemia[Ref]

Decreased hemoglobin (less than 10.1 g/dL in males; less than 9 g/dL in females), platelet count (less than 112 x 10[3]/mm3), and absolute neutrophil count (less than 0.8 x 10[3]/mm3) were reported in 3.1%, 2.3%, and 0.5% of patients, respectively.[Ref]

Dermatologic

Common (1% to 10%): Generalized pruritus
Uncommon (0.1% to 1%): Dermatophytosis, pruritus, urticaria, hyperhidrosis, rash, alopecia, erythematous rash, generalized rash, acne, allergic pruritus, maculopapular rash, popular rash, pruritic rash
Frequency not reported: Dermatitis[Ref]

Other

Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Fungal infection, abscess, flushing, hot flush, chills, pyrexia, peripheral edema, grip strength decreased

Local

Common (1% to 10%): Infusion site reactions (phlebitis)
Uncommon (0.1% to 1%): Infusion-related reactions, infusion site pain[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Bradycardia
Frequency not reported: Palpitations, tachycardia, hypertension[Ref]

Hepatic

Uncommon (0.1% to 1%): Elevated hepatic transaminases[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia, sleep disorder, anxiety, nightmare, irritability[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Drug hypersensitivity

Musculoskeletal

Uncommon (0.1% to 1%): Arthralgia, muscle spasms, back pain, limb discomfort, neck pain

Metabolic

Uncommon (0.1% to 1%): Dehydration, inadequately controlled diabetes mellitus, hyperkalemia

Ocular

Uncommon (0.1% to 1%): Optic nerve disorders, blurred vision, vitreous floaters
Frequency not reported: Asthenopia, visual impairment[Ref]

Respiratory

Uncommon (0.1% to 1%): Respiratory tract infection, cough, nasal dryness, pulmonary congestion

Genitourinary

Uncommon (0.1% to 1%): Vulvovaginal mycotic infection, vulvovaginal candidiasis, abnormal urine odor, vulvovaginal pruritus

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Sivextro (tedizolid)." Cubist Pharmaceuticals Inc, Lexington, MA.

Further information

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.

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