Rifapentine Side Effects
Some side effects of rifapentine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to rifapentine: oral tablet
Along with its needed effects, rifapentine 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 as soon as possible if any of the following side effects occur while taking rifapentine:More common
- Blood in urine
- joint pain
- lower back or side pain
- swelling of feet or lower legs
- Aggressive reaction
- black, tarry stools
- blood in stools
- pinpoint red spots on skin
- severe abdominal or stomach pain
- sore throat and fever
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
- severe or continuing headaches
- increase in blood pressure
Some side effects of rifapentine 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:Less common
- loss of appetite
This medicine commonly causes reddish-orange to reddish-brown discoloration of urine, stools, saliva, sputum, sweat, and tears. This side effect does not usually need medical attention.
For Healthcare Professionals
Applies to rifapentine: oral tablet
In general, there are no data concerning the adverse effects of rifapentine in monotherapy. The following adverse effects have been reported during treatment in the intensive phase (i.e., rifapentine 2 times a week and isoniazid, pyrazinamide and ethambutol daily for 2 months) and the continuation phase (i.e., rifapentine and isoniazid once a week for 4 months) in a clinical study in which 361 patients were randomized to the rifapentine regimen.
Hematologic side effects have included neutropenia (12.5%), lymphopenia (12.7%), anemia (12.2%), leukopenia (6.6%), thrombocytosis (5.5%), leukocytosis (3%), neutrophilia (2.5%), thrombocytopenia (2.5%), polycythemia (2.2%), and lymphadenopathy (1.1%). Lymphocytosis, hematoma, purpura, hypochromic anemia, normocytic anemia, and thrombosis have been reported in less than 1% of patients.
Metabolic side effects have included hyperuricemia (31.9), hypoglycemia (10%), hyperkalemia (9.1%), increased nonprotein nitrogen (3.9%), hyperglycemia (3.6%), increased lactate dehydrogenase (1.4%), and hyperphosphatemia (1.4%). Weight decrease, diabetes mellitus, increased alkaline phosphatase, hypophosphatemia, hypercalcemia, hypovolemia, and weight increase have been reported in less than 1% of patients.
Hyperuricemia was most likely related to pyrazinamide as only 2 cases were reported during the continuation phase, when pyrazinamide was no longer part of the regimen.
Genitourinary side effects have included proteinuria (13%), pyuria (21.6%), urinary tract infection (13.3%), urinary casts (8%), cystitis (1.7%), and hematuria (17.7%). Urethral disorder, dysuria, pyelonephritis, urinary incontinence, urination disorder, penis disorder, vaginitis, vaginal hemorrhage, positive cervical smear test, leukorrhea, male mastitis, prostatic disorder, and abortion have been reported in less than 1% of patients.
Respiratory side effects have included hemoptysis (8.3%), coughing (8%), upper respiratory tract infection (4.7%), bronchitis (2.5%), pharyngitis (1.9%), epistaxis (1.4%), and pleuritis (1.1%). Abnormal breath sounds, pneumothorax, pneumonia, pleural effusion, rhinitis, dyspnea, pneumonitis, sinusitis, increased sputum, pulmonary fibrosis, upper respiratory congestion, asthma, abnormal chest x-ray, bronchospasm, laryngeal edema, laryngitis, and respiratory disorder have been reported in less than 1% of patients.
Immunologic side effects have included influenza (7.8%), tuberculosis infection (2.5%), infection (1.4%), and herpes zoster (1.1%). Fungal infection, parasitic infection, and protozoan infection have been reported in less than 1% of patients.
Hepatic side effects have included elevated ALT (6.9%) and AST (5.8%). Bilirubinemia, hepatomegaly, jaundice, and hepatitis have been reported in less than 1% of patients.
Other side effects have included back pain (6.9%), pain (6.1%), chest pain (5.5%), accident injury (4.7%), abdominal pain (1.9%), fever (1.4%), fatigue (1.1%), dependent edema (1.1%), at least one case of influenza-like syndrome, and orange-red discoloration of body tissues and/or fluids (e.g., skin, teeth, tongue, urine, tears, sputum, saliva, feces, sweat, and cerebral spinal fluid). Abnormal laboratory test, legs edema, asthenia, face edema, abscess, peripheral edema, malaise, ear disorder not specified, otitis media, earache, otitis externa, and tympanic membrane perforation have been reported in less than 1% of patients.
Dermatologic side effects have included increased sweating (6.4%), rash (6.1%), pruritus (3.6%), acne (2.5%), skin disorder (1.4%), maculopapular rash (1.7%), and eczema (1.1%). Skin ulceration, urticaria, dry skin, furunculosis, skin discoloration, fungal dermatitis, nail disorder, alopecia, and erythematous rash have been reported in less than 1% of patients.
Clostridium difficile should be suspected in any patient who develops persistent or severe diarrhea following rifapentine therapy.
Gastrointestinal side effects have included anorexia (5.8%), nausea (2.5%), vomiting (2.5%), dyspepsia (2.8%), constipation (1.9%), diarrhea (1.9%), and hemorrhoids (1.4%). Tooth disorder, gastroenteritis, gastritis, esophagitis, cheilitis, dry mouth, pancreatitis, proctitis, salivary gland enlargement, tenesmus, and gastrointestinal disorder not specified have been reported in less than 1% of patients. Clostridium difficile associated diarrhea has been reported with almost all antibiotics, including the rifamycins.
Nervous system side effects have included headache (3.9%), dizziness (1.7%), tremor (1.4%), and insomnia (1.1%). Somnolence, seizure not specified, dysphonia, hypoesthesia, torticollis, hypertonia, hyporeflexia, meningitis, migraine headache, stupor, and taste loss have been reported in less than 1% of patients.
Musculoskeletal side effects have included arthralgia (4.4%), arthritis (1.1%), arthrosis (1.1%), and gout (1.1%). Myalgia, myositis, bone fracture, muscle weakness, and muscle spasm have been reported in less than 1% of patients.
Cardiovascular side effects have included hypertension (1.7%). Syncope, tachycardia, palpitation, orthostatic hypotension, pericarditis, deep thrombophlebitis, vascular disorder, and vasodilation have been reported in less than 1% of patients.
Ocular side effects have included conjunctivitis (2.5%). Eye pain and eye abnormality have been reported in less than 1% of patients.
Psychiatric side effects have included anxiety, confusion, drug abuse, aggressive reaction, and agitation in less than 1% of patients.
Oncologic side effects have included pulmonary carcinoma, neoplasm not specified, carcinoma, and lipoma in less than 1% of patients.
Renal side effects have included increased BUN (less than 1%).
More about rifapentine
- Other brands: Priftin
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