Priftin Side Effects
Generic Name: rifapentine
Please note - some side effects for Priftin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Priftin - for the Consumer
Priftin
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Priftin:
Seek medical attention right away if any of these SEVERE side effects occur when using Priftin:Acne; constipation; decreased appetite; diarrhea; discoloration of body fluids (red or orange); dizziness; headache; increased sweating; nausea; stomach pain; upset stomach; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody stools; fever; frequent or painful urination; irregular heartbeat; joint pain or swelling; severe or persistent diarrhea; stomach pain or cramps; symptoms of infection (eg, fever, chills, sore throat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite; general body discomfort); unusual tiredness or weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopPriftin Side Effects - for the Professional
Priftin
Serious and Otherwise Important Adverse Reactions
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
- Hypersensitivity [see Contraindications (4.1)]
- Hepatotoxicity [see Warnings and Precautions (5.4)]
- Hyperbilirubinemia [see Warnings and Precautions (5.5)]
- Discoloration of Body Fluids [see Warnings and Precautions (5.6)]
- Porphyria [see Warnings and Precautions (5.7)]
- Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.8)]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Priftin in a randomized, open label, active-controlled trial of patients with pulmonary tuberculosis, excluding those with HIV-infection. The population consisted of primarily of male subjects with a mean age of 37 ± 11 years. In the initial 2 month phase of treatment (60 days), 361 patients received rifapentine 600 mg twice a week in combination with daily isoniazid, pyrazinamide, and ethambutol and 361 subjects received rifampin in combination with isoniazid, pyrazinamide and ethambutol all administered daily. Ethambutol was discontinued when drug susceptibly testing was completed. During the 4 month continuation phase, 321 patients in the rifapentine group continued to receive rifapentine 600 mg dosed once weekly with isoniazid and 307 patients in the rifampin arm received twice weekly rifampin and isoniazid. Both treatment groups received pyridoxine (Vitamin B6) over the 6 month treatment period.
Twenty-two deaths occurred in the study (eleven in the rifampin combination therapy group and eleven in the rifapentine combination therapy group).
In the study, 18/361 (5.0%) rifampin combination therapy patients discontinued the study due to an adverse reaction compared to 11/361 (3.0%) rifapentine combination therapy patients. Three patients (two rifampin combination therapy patients and one rifapentine combination therapy patient) were discontinued in the Initial Phase as a result of hepatitis with increased liver function tests (ALT, AST, LDH, and bilirubin). Concomitant medications for all three patients included isoniazid, pyrazinamide, ethambutol, and pyridoxine. The two rifampin patients and one rifapentine patient recovered without sequelae.
As shown in Table 1, hyperuricemia was the most frequently reported reaction and was most likely related to the pyrazinamide since only two cases were reported in the Continuation Phase when this drug was no longer included in the treatment regimen.
Seven patients had adverse reactions associated with an overdose. In the rifampin combination group these reactions included hematuria, anorexia, back pain, arthralgia, and myalgia. In the rifapentine combination group these reactions included hematuria, neutropenia, hyperglycemia, ALT increased, hyperuricemia, pruritus, and arthritis.
The following table (Table 1) presents treatment-emergent adverse reactions associated with the use of any of the four drugs in the regimens (rifapentine/rifampin, isoniazid, pyrazinamide, or ethambutol) which occurred in ≥1% of patients during treatment and post-treatment through the first three months of follow-up.
| Initial Phase* | Continuation Phase† | Total‡ | ||||
|---|---|---|---|---|---|---|
| System Organ Class Preferred Term | Rifapentine Combination (N=361) N(%) |
Rifampin Combination (N=361) N(%) |
Rifapentine Combination (N=304) N(%) |
Rifampin Combination (N=317) N(%) |
Rifapentine Combination (N=361) N(%) |
Rifampin Combination (N=361) N(%) |
| Note: ≥1% refers to rifapentine in the TOTAL column. | ||||||
|
||||||
| RENAL & URINARY | ||||||
| Pyuria | 39 (10.8)_ | 56 (15.5) | 47 (14.8) | 36 (11.8) | 78 (21.6) | 83 (23.0) |
| Proteinuria | 36 (10.0) | 53 (14.7) | 14 (4.4) | 27 (8.9) | 47 (13.0) | 71 (19.7) |
| Hematuria | 39 (10.8) | 38 (10.5) | 32 (10.1) | 27 (8.9) | 64 (17.7) | 61 (16.9) |
| Urinary Tract Infection | 32 (8.9) | 24 (6.6) | 23 (7.3) | 10 (3.3) | 48 (13.3) | 32 (8.9) |
| Urinary Casts | 20 (5.5) | 22 (6.1) | 11 (3.5) | 7 (2.3) | 29 (8.0) | 28 (7.8) |
| Cystitis | 5 (1.4) | 6 (1.7) | 1 (0.3) | 1 (0.3) | 6 (1.7) | 7 (1.9) |
| METABOLIC & NUTRITIONAL | ||||||
| Hyperuricemia | 115 (31.9) | 83 (23.0) | 0 (0.0) | 2 (0.7) | 115 (31.9) | 83 (23.0) |
| Hyperkalemia | 14 (3.9) | 22 (6.1) | 20 (6.3) | 21 (6.9) | 33 (9.1) | 41 (11.4) |
| Hypoglycemia | 22 (6.1) | 27 (7.5) | 15 (4.7) | 11 (3.6) | 36 (10.0) | 35 (9.7) |
| Nonprotein Nitrogen Increased | 4 (1.1) | 3 (0.8) | 10 (3.2) | 15 (4.9) | 14 (3.9) | 17 (4.7) |
| Hyperglycemia | 10 (2.8) | 8 (2.2) | 4 (1.3) | 2 (0.7) | 13 (3.6) | 9 (2.5) |
| LDH Increased | 5 (1.4) | 7 (1.9) | 0 (0.0) | 2 (0.7) | 5 (1.4) | 9 (2.5) |
| Hyperphosphatemia | 2 (0.6) | 1 (0.3) | 3 (0.9) | 5 (1.6) | 5 (1.4) | 6 (1.7) |
| HEMATOLOGIC | ||||||
| Anemia | 41 (11.4) | 41 (11.4) | 5 (1.6) | 10 (3.3) | 44 (12.2) | 51 (14.1) |
| Lymphopenia | 38 (10.5) | 37 (10.2) | 10 (3.2) | 9 (3.0) | 46 (12.7) | 45 (12.5) |
| Neutropenia | 22 (6.1) | 21 (5.8) | 27 (8.5) | 24 (7.9) | 45 (12.5) | 41 (11.4) |
| Leukopenia | 16 (4.4) | 11 (3.0) | 11 (3.5) | 9 (3.0) | 24 (6.6) | 17 (4.7) |
| Leukocytosis | 6 (1.7) | 13 (3.6) | 5 (1.6) | 2 (0.7) | 11 (3.0) | 15 (4.2) |
| Neutrophilia | 5 (1.4) | 11 (3.0) | 4 (1.3) | 2 (0.7) | 9 (2.5) | 13 (3.6) |
| Thrombocytosis | 20 (5.5) | 13 (3.6) | 1 (0.3) | 0 (0.0) | 20 (5.5) | 13 (3.6) |
| Thrombocytopenia | 6 (1.7) | 6 (1.7) | 4 (1.3) | 6 (2.0) | 9 (2.5) | 11 (3.0) |
| Polycythemia | 3 (0.8) | 2 (0.6) | 5 (1.6) | 3 (1.0) | 8 (2.2) | 5 (1.4) |
| Lymphadenopathy | 4 (1.1) | 2 (0.6) | 0 (0.0) | 2 (0.7) | 4 (1.1) | 4 (1.1) |
| BODY AS A WHOLE - GENERAL | ||||||
| Back Pain | 15 (4.2) | 11 (3.0) | 11 (3.5) | 4 (1.3) | 25 (6.9) | 15 (4.2) |
| Pain | 14 (3.9) | 17 (4.7) | 8 (2.5) | 5 (1.6) | 22 (6.1) | 22 (6.1) |
| Chest Pain | 10 (2.8) | 11 (3.0) | 10 (3.2) | 5 (1.6) | 20 (5.5) | 16 (4.4) |
| Injury Accident | 5 (1.4) | 5 (1.4) | 12 (3.8) | 14 (4.6) | 17 (4.7) | 17 (4.7) |
| Abdominal Pain | 3 (0.8) | 3 (0.8) | 4 (1.3) | 4 (1.3) | 7 (1.9) | 7 (1.9) |
| Fever | 5 (1.4) | 7 (1.9) | 1 (0.3) | 1 (0.3) | 5 (1.4) | 7 (1.9) |
| Fatigue | 3 (0.8) | 1 (0.3) | 1 (0.3) | 3 (1.0) | 4 (1.1) | 4 (1.1) |
| Edema Dependent | 4 (1.1) | 1 (0.3) | 0 (0.0) | 1 (0.3) | 4 (1.1) | 2 (0.6) |
| DERMATOLOGIC | ||||||
| Rash | 15 (4.2) | 26 (7.2) | 8 (2.5) | 8 (2.6) | 22 (6.1) | 33 (9.1) |
| Sweating Increased | 19 (5.3) | 18 (5.0) | 5 (1.6) | 4 (1.3) | 23 (6.4) | 22 (6.1) |
| Pruritus | 10 (2.8) | 16 (4.4) | 3 (0.9) | 0 (0.0) | 13 (3.6) | 16 (4.4) |
| Acne | 9 (2.5) | 5 (1.4) | 0 (0.0) | 3 (1.0) | 9 (2.5) | 8 (2.2) |
| Skin Disorder | 2 (0.6) | 3 (0.8) | 3 (0.9) | 5 (1.6) | 5 (1.4) | 8 (2.2) |
| Rash Maculopapular | 6 (1.7) | 3 (0.8) | 0 (0.0) | 1 (0.3) | 6 (1.7) | 4 (1.1) |
| Eczema | 2 (0.6) | 2 (0.6) | 3 (0.9) | 2 (0.7) | 4 (1.1) | 3 (0.8) |
| RESPIRATORY | ||||||
| Hemoptysis | 27 (7.5) | 20 (5.5) | 6 (1.9) | 6 (2.0) | 30 (8.3) | 25 (6.9) |
| Coughing | 21 (5.8) | 8 (2.2) | 9 (2.8) | 11 (3.6) | 29 (8.0) | 17 (4.7) |
| Upper Respiratory Tract Infection | 5 (1.4) | 9 (2.5) | 12 (3.8) | 15 (4.9) | 17 (4.7) | 22 (6.1) |
| Bronchitis | 1 (0.3) | 1 (0.3) | 8 (2.5) | 1 (0.3) | 9 (2.5) | 2 (0.6) |
| Pharyngitis | 5 (1.4) | 0 (0.0) | 2 (0.6) | 5 (1.6) | 7 (1.9) | 5 (1.4) |
| Epistaxis | 2 (0.6) | 2 (0.6) | 3 (0.9) | 1 (0.3) | 5 (1.4) | 3 (0.8) |
| Pleuritis | 4 (1.1) | 1 (0.3) | 0 (0.0) | 1 (0.3) | 4 (1.1) | 2 (0.6) |
| GASTROINTESTINAL | ||||||
| Dyspepsia | 6 (1.7) | 11 (3.0) | 4 (1.3) | 6 (2.0) | 10 (2.8) | 17 (4.7) |
| Vomiting | 6 (1.7) | 14 (3.9) | 3 (0.9) | 3 (1.0) | 9 (2.5) | 17 (4.7) |
| Nausea | 7 (1.9) | 3 (0.8) | 2 (0.6) | 1 (0.3) | 9 (2.5) | 4 (1.1) |
| Constipation | 6 (1.7) | 1 (0.3) | 2 (0.6) | 1 (0.3) | 7 (1.9) | 2 (0.6) |
| Diarrhea | 5 (1.4) | 2 (0.6) | 2 (0.6) | 0 (0.0) | 7 (1.9) | 2 (0.6) |
| Hemorrhoids | 4 (1.1) | 0 (0.0) | 1 (0.3) | 0 (0.0) | 5 (1.4) | 0 (0.0) |
| INFECTIOUS DISEASE | ||||||
| Influenza | 9 (2.5) | 8 (2.2) | 22 (6.9) | 12 (3.9) | 28 (7.8) | 20 (5.5) |
| Infection Tuberculosis | 0 (0.0) | 5 (1.4) | 9 (2.8) | 4 (1.3) | 9 (2.5) | 9 (2.5) |
| Infection | 1 (0.3) | 2 (0.6) | 4 (1.3) | 4 (1.3) | 5 (1.4) | 6 (1.7) |
| Herpes Zoster | 2 (0.6) | 0 (0.0) | 2 (0.6) | 3 (1.0) | 4 (1.1) | 3 (0.8) |
| HEPATIC & BILIARY | ||||||
| ALT Increased | 18 (5.0) | 23 (6.4) | 7 (2.2) | 10 (3.3) | 25 (6.9) | 32 (8.9) |
| AST Increased | 15 (4.2) | 18 (5.0) | 7 (2.2) | 8 (2.6) | 21 (5.8) | 26 (7.2) |
| NEUROLOGIC | ||||||
| Headache | 11 (3.0) | 13 (3.6) | 3 (0.9) | 7 (2.3) | 14 (3.9) | 20 (5.5) |
| Dizziness | 5 (1.4) | 5 (1.4) | 1 (0.3) | 1 (0.3) | 6 (1.7) | 6 (1.7) |
| Tremor | 3 (0.8) | 1 (0.3) | 2 (0.6) | 0 (0.0) | 5 (1.4) | 1 (0.3) |
| PSYCHIATRIC | ||||||
| Anorexia | 14 (3.9) | 18 (5.0) | 8 (2.5) | 6 (2.0) | 21 (5.8) | 22 (6.1) |
| Insomnia | 2 (0.6) | 2 (0.6) | 2 (0.6) | 2 (0.7) | 4 (1.1) | 4 (1.1) |
| MUSCULOSKELETAL | ||||||
| Arthralgia | 13 (3.6) | 13 (3.6) | 3 (0.9) | 5 (1.6) | 16 (4.4) | 18 (5.0) |
| Arthritis | 4 (1.1) | 5 (1.4) | 1 (0.3) | 0 (0.0) | 4 (1.1) | 5 (1.4) |
| Arthrosis | 4 (1.1) | 1 (0.3) | 0 (0.0) | 1 (0.3) | 4 (1.1) | 2 (0.6) |
| Gout | 3 (0.8) | 1 (0.3) | 1 (0.3) | 0 (0.0) | 4 (1.1) | 1 (0.3) |
| CARDIOVASCULAR | ||||||
| Hypertension | 3 (0.8) | 5 (1.4) | 3 (0.9) | 2 (0.7) | 6 (1.7) | 7 (1.9) |
| OPHTHALMOLOGIC | ||||||
| Conjuctivitis | 8 (2.2) | 2 (0.6) | 1 (0.3) | 1 (0.3) | 9 (2.5) | 3 (0.8) |
In addition to the adverse reactions reported in Table 1, adverse reactions were reported post-treatment during the 3 month through 24 month follow-up period. Although the protocol for this study specified collection of serious adverse reactions during this period, some non-serious adverse reactions were reported as well. For the rifapentine combination group these included the following: hematuria, infection tuberculosis, proteinuria, urinary casts, hyperkalemia, hypoglycemia, injury accident, skin disorder, respiratory disorder, stupor, prostatic disorder.
Treatment-emergent adverse reactions reported during treatment and post-treatment through the first three months of follow-up in <1% of the rifapentine combination therapy patients are presented below by body system in order of frequency.
Renal & Urinary: urethral disorder, dysuria, pyelonephritis, urinary incontinence, urination disorder.
Metabolic & Nutritional: weight decrease, BUN increased, diabetes mellitus, alkaline phosphatase increased, hypophosphatemia, hypercalcemia, hypovolemia, weight increase.
Hematologic: lymphocytosis, hematoma, purpura, anemia hypochromic, anemia normocytic, thrombosis.
Body as a Whole - General: laboratory test abnormal, edema legs, asthenia, edema face, abscess, edema peripheral, malaise.
Dermatologic: skin ulceraction, urticaria, dry skin, furunculosis, skin discoloration, dermatitis fungal, nail disorder, alopecia, rash erythematous.
Respiratory: abnormal breath sounds, pneumothorax, pneumonia, pleural effusion, rhinitis, dyspnea, pneumonitis, sinusitis, sputum increased, pulmonary fibrosis, upper respiratory congestion, asthma, chest x-ray abnormal, bronchospasm, laryngeal edema, laryngitis, respiratory disorder.
Gastrointestinal: tooth disorder, gastroenteritis, gastritis, esophagitis, cheilitis, dry mouth, pancreatitis, proctitis, salivary gland enlargement, tenesmus, gastrointestinal disorder not specified.
Infectious Disease: infection fungal, infection parasitic, infection protozoan.
Hepatic & Biliary: bilirubinemia, hepatomegaly, jaundice.
Neurologic: somnolence, seizure not specified, dysphonia, hypoesthesia, torticollis, hypertonia, hyporeflexia, meningitis, migraine headache, stupor.
Psychiatric: anxiety, confusion, drug abuse, aggressive reaction, agitation.
Musculoskeletal: myalgia, myositis, bone fracture, muscle weakness, muscle spasm.
Cardiovascular: syncope, tachycardia, palpitation, hypotension orthostatic, pericarditis.
Reproductive Disorders: penis disorder, vaginitis, vaginal hemorrhage, cervical smear test positive, leukorrhea, mastitis male, prostatic disorder.
Hearing & Vestibular: ear disorder not specified, otitis media, earache, otitis externa, tympanic membrane perforation.
Ophthalmologic: eye pain, eye abnormality.
Neoplasms: pulmonary carcinoma, neoplasm not specified, carcinoma, lipoma.
Vascular (Extracardiac): thrombophlebitis deep, vascular disorder, vasodilation.
Special Senses Other: taste loss.
Pregnancy, puerperium and perinatal conditions: abortion
In another randomized, open-label trial in 1075 HIV seronegative and seropositive patients with pulmonary tuberculosis the overall adverse event rate did not differ substantially from the previous trial. Patients who had completed an initial 2 month phase of treatment with 4 drugs were randomly assigned to receive either rifapentine 600 mg and isoniazid once weekly or rifampin and isoniazid twice weekly for the 4 month continuation phase.
In the rifapentine arm, 502 HIV seronegative and 36 HIV seropositive patients were randomized and in the rifampin arm 502 HIV seronegative and 35 HIV seropositive patients were randomized to treatment.
The death rate among all study participants was 71/1075 (6.6%) and did not differ between the two treatment groups (6.5% for the rifapentine combination regimen compared to 6.7% for the rifampin combination regimen; P = 0.87).
There were 526 treatment-emergent adverse events regardless of causality reported from 251 patients treated with the rifapentine combination regimen and 513 adverse events reported from 248 patients treated with the rifampin combination regimen. On both study arms the most frequently reported adverse events were hyperglycemia, pneumonia, liver toxicity, and death and were consistent with concurrent underlying conditions that included alcohol abuse, pancreatitis and HIV.
There was a greater percentage of patients in the rifampin combination arm who developed hepatic adverse events (35/513; 6.8 %) compared to 20/526 (3.8%) in the rifapentine combination arm. The types of other adverse events were similar between the treatment arms.
Hyperuricemia was not reported as an adverse reaction in this study of continuation phase therapy. In the previous study which evaluated initial therapy containing pyrazinamide, hyperuricemia was reported in 32% of rifapentine and 23% of rifampin combination treated patients.
TopSide Effects by Body System - for Healthcare Professionals
General
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
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
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
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
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
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
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
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
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.
Gastrointestinal
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
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
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
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
Ocular side effects have included conjunctivitis (2.5%). Eye pain and eye abnormality have been reported in less than 1% of patients.
Psychiatric
Psychiatric side effects have included anxiety, confusion, drug abuse, aggressive reaction, and agitation in less than 1% of patients.
Oncologic
Oncologic side effects have included pulmonary carcinoma, neoplasm not specified, carcinoma, and lipoma in less than 1% of patients.
Renal
Renal side effects have included increased BUN (less than 1%).
TopMore Priftin resources
- Priftin Prescribing Information (FDA)
- Priftin Concise Consumer Information (Cerner Multum)
- Priftin Monograph (AHFS DI)
- Priftin MedFacts Consumer Leaflet (Wolters Kluwer)
- Priftin Advanced Consumer (Micromedex) - Includes Dosage Information
- Rifapentine Professional Patient Advice (Wolters Kluwer)
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