Ojjaara Side Effects
Generic name: momelotinib
Medically reviewed by Drugs.com. Last updated on Jan 29, 2024.
Note: This document provides detailed information about Ojjaara.
Applies to momelotinib: oral tablet Side Effects associated with momelotinib. Some dosage forms listed on this page may not apply specifically to the brand name Ojjaara.
Applies to momelotinib: oral tablet.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment and for 1 week after the last dose. If you think you have become pregnant, tell your doctor right away.
This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections (eg, hepatitis B). Avoid being near people who are sick or have infections while you are using this medicine. 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 clipper.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may increase your risk of serious heart or blood vessel problems, including heart attack or stroke. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.
Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing. These may be symptoms of serious blood clots (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis).
This medicine may increase your risk of cancer (eg, lymphoma, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin.
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 Ojjaara
Along with its needed effects, momelotinib (the active ingredient contained in Ojjaara) 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 momelotinib:
More common side effects
- black, tarry stools
- bladder pain
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the stools
- bloody or cloudy urine
- blurred vision
- chest pain or tightness
- confusion
- coughing up blood
- cough or hoarseness
- diarrhea
- difficult, burning, or painful urination
- difficulty in breathing or swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fainting
- fast, slow, or irregular heartbeat
- fever or chills
- frequent urge to urinate
- headache
- increased menstrual flow or vaginal bleeding
- loss of taste or smell
- lower back or side pain
- muscle or body aches
- nausea or vomiting
- nosebleeds
- pale skin
- paralysis
- pinpoint red spots on the skin
- prolonged bleeding from cuts
- rapid weight gain
- red or dark brown urine
- sore throat
- stuffy or runny nose
- sweating
- tingling of the hands or feet
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Less common side effects
- blue lips, fingernails, or skin
- burning, numbness, tingling, or painful sensations
- decreased urine output
- dilated neck veins
- nerve pain
- swelling of the face, fingers, feet, or lower legs
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
Incidence not known
- anxiety
- chest discomfort
- dark urine
- difficulty in speaking
- double vision
- general feeling of illness
- inability to move the arms, legs, or facial muscles
- inability to speak
- loss of appetite
- pain, redness, or swelling in the arm or leg
- pain or discomfort in the arms, jaw, back, or neck
- pains in the chest, groin, or legs, especially the calves of legs
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- severe headaches of sudden onset
- shiny bump
- slow speech
- stomach pain, severe
- sudden loss of coordination
- sudden onset of slurred speech
- sudden vision changes
- swollen glands
- white, yellow or waxy scar-like area
- yellow eyes or skin
Other side effects of Ojjaara
Some side effects of momelotinib 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 side effects
- back pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- itching skin
- pain in the arms or legs
Less common side effects
- feeling of warmth
- redness of the face, neck, arms and occasionally, upper chest
For healthcare professionals
Applies to momelotinib: oral tablet.
General adverse events
Serious adverse reactions occurred in up to 35% of patients and the most common of these reactions included bacterial and viral infections, hemorrhage, acute kidney injury, pneumonia, pyrexia, thrombosis, diarrhea, fatigue, syncope, thrombocytopenia, dizziness, heart failure, arrhythmia, respiratory failure, and renal and urinary tract infection. The most common fatal adverse reaction was viral infection.
The most common adverse reaction leading to the drug discontinuation or requiring dosage reduction and/or treatment interruption were viral infection, bacterial infection, dizziness, fatigue, diarrhea, elevated liver enzymes, pneumonia, abdominal pain, hypotension, thrombocytopenia, neutropenia, and thrombocytopenia.[Ref]
Cardiovascular
- Very common (10% or more): Hemorrhage (up to 22%), hypotension (up to 14%)
- Common (1% to 10%): Thrombosis, arrhythmia, heart failure, hematoma, flushing[Ref]
Dermatologic
- Very common (10% or more): Rash (up to 12%), pruritus (11%)[Ref]
Cases of rash requiring hospitalization have been reported. Rash included maculo-papular rash, erythematous rash, drug eruption, follicular rash, macular rash, and pustular rash.[Ref]
Gastrointestinal
- Very common (10% or more): Diarrhea (up to 22%), nausea (up to 20%), abdominal pain (up to 18%)
- Common (1% to 10%): Vomiting, constipation, oral herpes[Ref]
Genitourinary
- Very common (10% or more): Urinary tract infection (12%)[Ref]
Hematologic
- Very common (10% or more): Thrombocytopenia (up to 28%)
- Common (1% to 10%): Neutropenia[Ref]
Thrombocytopenia included decreased platelet count.
Neutropenia included decreased neutrophil count.[Ref]
Hepatic
- Very common (10% or more): Elevated liver enzymes (up to 11%), increased ALT and AST (20%)
- Common (1% to 10%): Transaminase elevations
- Frequency not reported: Reversible drug-induced liver injury[Ref]
Metabolic
- Common (1% to 10%): Vitamin B1 deficiency[Ref]
Musculoskeletal
- Very common (10% or more): Pain in extremity (up to 12%)
- Common (1% to 10%): Back pain, arthralgia[Ref]
Nervous system
- Very common (10% or more): Dizziness (up to 24%), headache (up to 11%)
- Common (1% to 10%): Syncope, paresthesia, peripheral neuropathy, vertigo
- Frequency not reported: Neuralgia, peripheral motor neuropathy, polyneuropathy[Ref]
Peripheral neuropathy included peripheral sensory neuropathy, peripheral motor neuropathy, peripheral neuropathy, peripheral sensorimotor neuropathy, neuralgia, and polyneuropathy.[Ref]
Ocular
- Common (1% to 10%): Blurred vision[Ref]
Other
- Very common (10% or more): Infections (39.5%), fatigue (up to 22%), bacterial infection (up to 21%), pyrexia (up to 12%), renal and urinary tract infection (up to 12%), peripheral edema (up to 11%), asthenia (10.9%)
- Common (1% to 10%): Viral infection (excludes opportunistic infections), contusion
- Frequency not reported: Fungal infections (excludes opportunistic infections)[Ref]
Infections included urinary tract infection, upper respiratory tract infection, COVID-19, herpes zoster; excludes opportunistic infections.[Ref]
Renal
- Very common (10% or more): Renal infection (12%)
- Common (1% to 10%): Acute kidney injury, cystitis[Ref]
Respiratory
- Very common (10% or more): Cough (up to 14%)
- Common (1% to 10%): Pneumonia, respiratory failure, upper respiratory tract infection, nasopharyngitis, COVID-19, bronchitis[Ref]
See also:
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References
1. (2023) "Product Information. Ojjaara (momelotinib)." GlaxoSmithKline
2. (2024) "Product Information. Omjjara (momelotinib)." GlaxoSmithKline Australia Pty Ltd
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Further information
Ojjaara 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.