Applies to omadacycline: oral tablet. Other dosage forms:

• intravenous powder for solution

Serious side effects of Omadacycline

Along with its needed effects, omadacycline 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 omadacycline:

Less common

• Blurred vision
• dizziness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• hives, itching, 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
• sore mouth or tongue
• stomach pain
• swelling of the eyelids, face, lips, hands, or feet
• thick, white vaginal discharge with mild or no odor
• tightness in the chest
• troubled breathing or swallowing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• white patches in the mouth or on the tongue

Other side effects of Omadacycline

Some side effects of omadacycline 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
• vomiting

Less common

• Belching
• change or loss in taste
• constipation
• diarrhea
• feeling of constant movement of self or surroundings
• heartburn
• increased sweating
• indigestion
• mouth or throat pain
• sensation of spinning
• stomach discomfort or upset
• trouble sleeping
• unusual drowsiness, dullness, or feeling of sluggishness

For Healthcare Professionals

Applies to omadacycline: intravenous powder for injection, oral tablet.

General

In the community-acquired bacterial pneumonia clinical trial, serious side effects were reported in 6% of patients treated with this drug and 6.7% of patients treated with moxifloxacin; therapy was discontinued due to any side effect in 5.5% of patients treated with this drug and 7% of patients treated with moxifloxacin. In the pooled acute bacterial skin and skin structure infection trials, serious side effects were reported in 2.3% of patients treated with this drug and 1.9% of patients treated with comparator; therapy was discontinued due to side effects in 1.7% of patients treated with this drug and 1.5% of patients treated with comparator.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 30%), vomiting (up to 17%)

Common (1% to 10%): Diarrhea, constipation

Frequency not reported: Abdominal pain, dyspepsia, oral candidiasis, increased lipase^[Ref]

Local

Common (1% to 10%): Infusion site reactions (infusion site extravasation, pain, erythema, swelling, inflammation, irritation, peripheral swelling, skin induration)^[Ref]

Hepatic

Common (1% to 10%): Increased ALT, increased AST, increased GGT

Frequency not reported: Increased bilirubin^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Frequency not reported: Tachycardia, atrial fibrillation^[Ref]

Nervous system

Common (1% to 10%): Headache

Frequency not reported: Dysgeusia, lethargy, vertigo^[Ref]

Psychiatric

Common (1% to 10%): Insomnia^[Ref]

Other

In the community-acquired bacterial pneumonia clinical trial, mortality imbalance was observed with 8 deaths (2%) in patients treated with this drug compared to 4 deaths (1%) in patients treated with moxifloxacin. All deaths (both treatment groups) occurred in patients older than 65 years; most patients had multiple comorbidities. Causes of death varied and included worsening and/or complications of infection and underlying conditions. The cause of the mortality imbalance has not been established.

In acute bacterial skin and skin structure infection trials, 1 death (0.1%) was reported in patients treated with this drug and 3 deaths (0.4%) were reported in patients treated with linezolid.^[Ref]

Common (1% to 10%): Death

Frequency not reported: Fatigue, increased alkaline phosphatase, mortality imbalance^[Ref]

Hematologic

Frequency not reported: Anemia, thrombocytosis^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity^[Ref]

Dermatologic

Frequency not reported: Pruritus, erythema, hyperhidrosis, urticaria^[Ref]

Respiratory

Frequency not reported: Oropharyngeal pain^[Ref]

Musculoskeletal

Frequency not reported: Increased creatine phosphokinase^[Ref]

Genitourinary

Frequency not reported: Vulvovaginal mycotic infection^[Ref]