Pretomanid Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 17, 2024.

Applies to pretomanid: oral tablet.

Precautions

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.

If your symptoms do not improve or if they get worse, call your doctor.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Check with your doctor right away if you have any changes to your eyes, such as redness, itching, swelling, or vision changes while you are using this medicine. Your doctor may want you to have your eyes checked by an eye doctor.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Lactic acidosis may occur in some patients. Check with your doctor right away if you have fast breathing, trouble breathing, nausea and vomiting, lightheadedness, severe weakness, tiredness, or confusion while using this medicine.

Avoid drinking alcohol while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of pretomanid

Along with its needed effects, pretomanid 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 pretomanid:

Other side effects of pretomanid

Some side effects of pretomanid 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:

For healthcare professionals

Applies to pretomanid: oral tablet.

General adverse events

The following adverse reactions were reported in patients receiving the combination regimen of pretomanid, bedaquiline, and linezolid, unless otherwise specified.

The manufacturer product information for bedaquiline and linezolid should be consulted for associated adverse reactions.^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, ECG QT prolongation
• Uncommon (0.1% to 1%): Hypotension, palpitations, sinus tachycardia

Bedaquiline:

• Frequency not reported: QT prolongation

Hypertension included increased blood pressure and hypertension.

Dermatologic

• Very common (10% or more): Acne (up to 29%), rash (up to 19%), pruritus (up to 16%)
• Common (1% to 10%): Dry skin, alopecia
• Uncommon (0.1% to 1%): Allergic dermatitis, skin hyperpigmentation

Acne included acne and acneiform dermatitis.

Rash included rash, erythematous rash, maculopapular rash, papular rash, vesicular rash, and nodular rash.

Pruritus included pruritus, generalized pruritus, and pruritic rash.

Gastrointestinal

• Very common (10% or more): Nausea (up to 30%), vomiting (up to 26%), dyspepsia (up to 19%), abdominal pain (up to 14%)
• Common (1% to 10%): Diarrhea, constipation, gastritis, gastroesophageal reflux disease, pancreatitis, oral candidiasis
• Uncommon (0.1% to 1%): Abdominal distension, glossodynia, hematemesis

Abdominal pain included abdominal pain, lower abdominal pain, upper abdominal pain, and abdominal tenderness.

Gastritis included gastritis and chronic gastritis.

Pancreatitis included pancreatitis and hemorrhagic pancreatitis.

Oral candidiasis included oral candidiasis, oral fungal infection, and angular cheilitis.

Genitourinary

• Uncommon (0.1% to 1%): Albumin present in urine, erectile dysfunction, metrorrhagia

Hematologic

• Very common (10% or more): Anemia (up to 37%), myelosuppression (up to 29%)
• Common (1% to 10%): Leukopenia, neutropenia, thrombocytopenia, decreased hemoglobin, decreased absolute neutrophil count, decreased platelets
• Uncommon (0.1% to 1%): Lymphopenia, pancytopenia
• Frequency not reported: Hematopoietic cytopenia

Linezolid:

• Frequency not reported: Myelosuppression

Anemia included anemia and decreased hemoglobin.

Myelosuppression included anemia, leukopenia, thrombocytopenia, and pancytopenia.

Neutropenia included neutropenia and decreased neutrophil count.

Thrombocytopenia included thrombocytopenia and decreased platelet count.

The most common hematopoietic cytopenia was anemia. In 1 study, most cytopenias started after 2 weeks of therapy. Cytopenias that were considered serious occurred in 3 patients, neutropenia in 1 patient and anemia in 2 patients; all 3 serious adverse reactions lead to interruption of linezolid or all components of the combination regimen, and all resolved.

Decreased hemoglobin (up to 7.9 mg/dL), decreased absolute neutrophil count (up to 749/mm3), and decreased platelets (up to 49,999/mm3) have been reported in up to 4%, up to 4%, and up to 1% of patients, respectively.

According to some authorities, anemia, leukopenia, neutropenia, thrombocytopenia, lymphopenia, and pancytopenia were considered to be attributed to linezolid.

Hepatic

• Very common (10% or more): Increased transaminases (up to 28%), liver-related adverse reaction (up to 26%), increased GGT (up to 13%)
• Common (1% to 10%): Increased ALT, increased AST, increased total bilirubin, hyperbilirubinemia
• Uncommon (0.1% to 1%): Hepatomegaly, jaundice

Increased transaminases included increased ALT, increased AST, drug-induced liver injury, increased hepatic enzyme, abnormal hepatic function, increased liver function test, and increased transaminases.

Hyperbilirubinemia included hyperbilirubinemia and increased blood bilirubin.

Increased ALT (greater than 3 to 5 times the upper limit of normal [3 to 5 x ULN]: up to 8%; greater than 5 to 8 x ULN: up to 4%; greater than 8 x ULN: up to 2%), increased AST (greater than 3 to 5 x ULN: up to 5%; greater than 5 to 8 x ULN: up to 2%; greater than 8 x ULN: up to 2%), and increased total bilirubin (greater than 1 to 2 x ULN: up to 5%; greater than 2 x ULN: up to 2%) have been reported.

Metabolic

• Very common (10% or more): Decreased appetite (up to 16%)
• Common (1% to 10%): Hyperamylasemia, hypoglycemia, abnormal loss of weight, hyperlipasemia, lactic acidosis, hypomagnesemia
• Uncommon (0.1% to 1%): Increased blood uric acid, dehydration, hypocalcemia, hypovolemia
• Frequency not reported: Hyperglycemia, hypokalemia, hyperkalemia, hyponatremia, hypophosphatemia

Linezolid:

• Frequency not reported: Lactic acidosis

Hyperamylasemia included increased amylase and hyperamylasemia.

Hyperlipasemia included hyperlipasemia and increased lipase. Increased lipase (greater than 2 x ULN) has been reported in up to 5% of patients.

Lactic acidosis included lactic acidosis and acidosis.

According to some authorities, lactic acidosis was considered to be attributed to linezolid.

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (up to 22%)
• Common (1% to 10%): Muscle spasms, increased blood creatine phosphokinase
• Uncommon (0.1% to 1%): Increased blood creatine phosphokinase MB

Musculoskeletal pain included arthralgia, back pain, costochondritis, myalgia, pain in extremity, and musculoskeletal pain.

Muscle spasms included muscle spasms and musculoskeletal stiffness.

Nervous system

• Very common (10% or more): Peripheral neuropathy (up to 81%), headache (up to 22%)
• Common (1% to 10%): Dysgeusia, dizziness
• Frequency not reported: Seizure

Linezolid:

• Frequency not reported: Peripheral neuropathy

Peripheral neuropathy included burning sensation, hypoesthesia, hyporeflexia, peripheral neuropathy, paresthesia, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, polyneuropathy, and sensory disturbance.

In 1 study, peripheral neuropathy was reported in 81% of patients; most cases (64%) occurred after 8 weeks of therapy and led to dosing interruption, dose reduction, or discontinuation of linezolid. Severe, moderate, and mild peripheral neuropathy occurred in 22%, 32%, and 26% of patients, respectively; no adverse reaction related to peripheral neuropathy resulted in discontinuation of the entire study regimen.

According to some authorities, peripheral neuropathy was considered to be attributed to linezolid.

Ocular

• Common (1% to 10%): Visual impairment, eye irritation, eye pain, optic neuropathy, dry eye
• Uncommon (0.1% to 1%): Lens disorder, eye pruritus, eye swelling, papilledema, presbyopia

Linezolid:

• Frequency not reported: Optic neuropathy

Visual impairment included blurred vision, reduced visual acuity, and visual impairment.

Optic neuropathy included optic neuropathy and optic neuritis.

In 1 study, 2 patients (2%) developed optic neuropathy after 16 weeks of therapy. Both were serious, confirmed on retinal examination as optic neuropathy/neuritis, and led to discontinuation of linezolid; both adverse reactions resolved.

According to some authorities, optic neuropathy was considered to be attributed to linezolid.

Other

• Common (1% to 10%): Fatigue, increased blood alkaline phosphatase
• Uncommon (0.1% to 1%): Malaise, deafness

Fatigue included fatigue and asthenia.

Psychiatric

• Common (1% to 10%): Insomnia
• Uncommon (0.1% to 1%): Anxiety, depression

Renal

• Common (1% to 10%): Increased blood creatinine, increased blood urea
• Uncommon (0.1% to 1%): Decreased renal CrCl

Respiratory

• Very common (10% or more): Pleuritic pain (up to 14%), hemoptysis (up to 11%)
• Common (1% to 10%): Cough
• Uncommon (0.1% to 1%): Epistaxis

Cough included cough and productive cough.

See also:

Further information

Pretomanid side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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