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

Summary

More frequent side effects include: diarrhea. Continue reading for a comprehensive list of adverse effects.

Applies to tedizolid: oral tablet. Other dosage forms:

• intravenous powder for solution

Serious side effects of Sivextro

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

• Blurred vision
• chest tightness
• diarrhea
• dizziness
• fast, slow, pounding, or irregular heartbeat or pulse
• fever
• headache
• hives or welts, itching, or skin rash
• hoarseness
• irritation
• itching of the vagina or genitals
• joint pain, stiffness, or swelling
• nervousness
• pale skin
• pounding in the ears
• redness of the skin
• severe stomach cramps and pain
• sore mouth or tongue
• stomach tenderness
• swelling of the eyelids, face, lips, hands, or feet
• thick, white vaginal discharge with mild or no odor
• trouble breathing or swallowing
• unusual bleeding or bruising
• unusual tiredness or weakness
• watery or severe diarrhea, which may also be bloody
• white patches in the mouth or on the tongue

Incidence not known

• Black, tarry stools
• blood in the urine or stools
• chills
• cough
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on the skin

Other side effects of Sivextro

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:

More common

• Nausea

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• double vision
• feeling of warmth
• feeling that you cannot keep your eyes open
• increased sensitivity of the eyes to light
• redness of the face, neck, arms, and occasionally, upper chest
• seeing floating spots before the eyes
• sore neck, shoulders, or back
• sore, tired, burning, or itching eyes
• trouble concentrating
• trouble sleeping
• vomiting
• watery or dry eyes

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%): Clostridioides 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 3.4%, 2.1%, and 0.4% 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/injection-related side effects (including but not limited to phlebitis, injection/infusion-site pain, injection/infusion-site swelling, injection-site reaction, injection-site erythema, injection-site induration, infusion-related reaction), 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

Frequency not reported: Increased ALT, increased AST, increased GGT, abnormal liver function tests^[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