Applies to pretomanid: oral tablet.
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:
More common
- Abdominal or stomach pain or tenderness
- black, tarry, stools
- bleeding gums
- blindness
- blood in the urine or stools
- blurred vision
- burning, numbness, tingling, or painful sensations
- chills
- clay colored stools
- cough
- dark urine
- decreased appetite
- decreased vision
- eye pain
- fever
- headache
- itching or skin rash
- loss of appetite
- lower back or side pain
- nausea and vomiting
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- sore throat
- swelling of the feet or lower legs
- troubled breathing with exertion
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- weakness in the arms, hands, legs, or feet
- yellow eyes or skin
Less common
- Chest pain
- coma
- decreased urine output
- dizziness
- drowsiness
- dry mouth
- fast or irregular heartbeat
- increased thirst
- irregular heartbeat
- mood or mental changes
- muscle pain or cramps
- muscle spasms (tetany) or twitching
- numbness or tingling in the hands, feet, or lips
- seizures
- swelling of the face, ankles, or hands
- swollen glands
- trembling
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:
More common
- Acid or sour stomach
- belching
- blemishes on the skin
- heartburn
- indigestion
- pimples
- stomach discomfort, upset, or pain
Less common
- Bloating
- change in taste
- constipation
- diarrhea
- dry skin
- loss of taste
- pains in the stomach, side, or abdomen, possibly radiating to the back
- trouble sleeping
For Healthcare Professionals
Applies to pretomanid: oral tablet.
General
When this drug is used with bedaquiline and linezolid, the respective manufacturer product information should be consulted for associated side effects.
Overall, patients who used linezolid 600 mg twice a day had a similar safety profile to those who used 1200 mg once a day.[Ref]
Nervous system
Very common (10% or more): Peripheral neuropathy (burning sensation, hypoesthesia, hyporeflexia, peripheral neuropathy, paresthesia, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy; 81%), headache (28%)
Frequency not reported: Dysgeusia, dizziness, seizure
Linezolid:
-Frequency not reported: Peripheral neuropathy[Ref]
Most reports of peripheral neuropathy (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 side effect related to peripheral neuropathy resulted in discontinuation of the entire study regimen.[Ref]
Dermatologic
Very common (10% or more): Acne (acne, acneiform dermatitis; 39%), rash (rash, erythematous rash, maculopapular rash, papular rash, vesicular rash; 21%), pruritus (pruritus, generalized pruritus, pruritic rash; 20%)
Common (1% to 10%): Dry skin[Ref]
Hematologic
Very common (10% or more): Anemia (37%)
Common (1% to 10%): Neutropenia, thrombocytopenia, decreased hemoglobin, decreased absolute neutrophil count, decreased platelets
Frequency not reported: Leukopenia, hematopoietic cytopenia, myelosuppression (including anemia, leukopenia, thrombocytopenia, pancytopenia)
Linezolid:
-Frequency not reported: Myelosuppression[Ref]
The most common hematopoietic cytopenia was anemia. 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 side effects lead to interruption of linezolid or all components of the combination regimen and all resolved.
Decreased hemoglobin (up to 7.9 mg/dL), absolute neutrophil count (up to 749/mm3), and platelets (up to 49,999/mm3) have been reported in 6%, 5%, and 2% of patients, respectively.[Ref]
Gastrointestinal
Increased lipase (greater than 2 times the upper limit of normal [2 x ULN]) has been reported in 5% of patients.[Ref]
Very common (10% or more): Nausea (37%), vomiting (34%), dyspepsia (24%), abdominal pain (abdominal pain, lower abdominal pain, upper abdominal pain, abdominal tenderness; 19%), diarrhea (10%)
Common (1% to 10%): Constipation, gastritis, increased lipase
Frequency not reported: Pancreatitis[Ref]
Musculoskeletal
Very common (10% or more): Musculoskeletal pain (arthralgia, back pain, costochondritis, myalgia, pain in extremity; 29%)
Frequency not reported: Increased blood creatine phosphokinase[Ref]
Hepatic
Very common (10% or more): Increased transaminases (increased ALT, increased AST, drug-induced liver injury, increased hepatic enzyme, abnormal hepatic function, increased liver function test, increased transaminases; 28%), increased GGT (17%)
Common (1% to 10%): Increased ALT, increased AST, increased total bilirubin[Ref]
Increased ALT (greater than 3 and up to 5 x ULN: 6%; greater than 5 and up to 8 x ULN: 5%; greater than 8 x ULN: 1%), AST (greater than 3 and up to 5 x ULN: 6%; greater than 5 and up to 8 x ULN: 2%; greater than 8 x ULN: 1%), and total bilirubin (greater than 1 and up to 2 x ULN: 6%; greater than 2 x ULN: 2%) have been reported.[Ref]
Metabolic
Very common (10% or more): Decreased appetite (22%), hyperamylasemia (increased amylase, hyperamylasemia; 14%), hypoglycemia (11%), abnormal loss of weight (10%)
Common (1% to 10%): Hyperlipasemia (hyperlipasemia, increased lipase)
Frequency not reported: Hypomagnesemia, hyperglycemia, hypokalemia, hyperkalemia, hyponatremia, lactic acidosis
Linezolid:
-Frequency not reported: Lactic acidosis[Ref]
Respiratory
Very common (10% or more): Pleuritic pain (19%), lower respiratory tract infection (bronchitis, influenza, lower respiratory tract infection, pneumonia; 15%), hemoptysis (13%), cough (cough, productive cough; 12%)[Ref]
Ocular
Very common (10% or more): Visual impairment (blurred vision, reduced visual acuity, visual impairment; 12%)
Frequency not reported: Optic neuropathy
Linezolid:
-Frequency not reported: Optic neuropathy[Ref]
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 side effects resolved.[Ref]
Cardiovascular
Common (1% to 10%): Hypertension (increased blood pressure, hypertension), ECG QT prolonged
Bedaquiline:
-Frequency not reported: QT prolongation[Ref]
Psychiatric
Common (1% to 10%): Insomnia[Ref]
Other
Frequency not reported: Increased blood alkaline phosphatase[Ref]
Renal
Frequency not reported: Increased blood creatinine[Ref]
