Rilutek Side Effects
Generic Name: riluzole
Please note - some side effects for Rilutek may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Rilutek - for the Consumer
Rilutek
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 Rilutek:
Seek medical attention right away if any of these SEVERE side effects occur when using Rilutek:Abnormal skin sensations around the mouth; cough; diarrhea; dizziness; drowsiness; feeling of a whirling motion; headache; loss of appetite; muscle weakness; nausea; stomach pain; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems; fast or irregular heartbeat; fever, chills, or sore throat; frequent or painful urination; pneumonia; swelling of the hands or feet; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .
TopRilutek Side Effects - for the Professional
Rilutek
The most commonly observed AEs associated with the use of Rilutek more frequently than placebo treated patients were: asthenia, nausea, dizziness, decreased lung function, diarrhea, abdominal pain, pneumonia, vomiting, vertigo, circumoral paresthesia, anorexia, and somnolence. Asthenia, nausea, dizziness, diarrhea, anorexia, vertigo, somnolence, and circumoral paresthesia were dose related.
Approximately 14% (n = 141) of the 982 individuals with ALS who received Rilutek in pre-marketing clinical trials discontinued treatment because of an adverse experience. Of those patients who discontinued due to adverse events, the most commonly reported were: nausea, abdominal pain, constipation, and ALT elevations. In a dose response study in ALS patients, the rates of discontinuation of Rilutek for asthenia, nausea, abdominal pain, and ALT elevation were dose related.
Incidence in Controlled ALS Clinical Studies
Table 1 lists treatment-emergent signs and symptoms that occurred in at least 2% of patients with ALS treated with Rilutek (n=794) participating in placebo-controlled trials and were numerically greater in the patients treated with Rilutek 100 mg/day than with placebo or for which a dose response relationship is suggested.
The prescriber should be aware that these figures cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and non-drug factors to the AE incidences in the population studied.
| Body System / Adverse Event* |
Riluzole 50 mg/day (N=237) |
Riluzole 100 mg/day (N=313) |
Riluzole 200 mg/day (N=244) |
Placebo (N=320) |
|---|---|---|---|---|
|
||||
| Body as a Whole | ||||
| Asthenia | 14.8 | 19.2 | 20.1 | 12.2 |
| Headache | 8.0 | 7.3 | 7.0 | 6.6 |
| Abdominal pain | 6.8 | 5.1 | 7.8 | 3.8 |
| Back pain | 1.7 | 3.2 | 4.1 | 2.5 |
| Aggravation reaction | 0.4 | 1.3 | 2.0 | 0.9 |
| Malaise | 0.4 | 0.6 | 1.2 | 0.0 |
| Digestive | ||||
| Nausea | 12.2 | 16.3 | 20.5 | 10.6 |
| Vomiting | 4.2 | 4.2 | 4.5 | 1.6 |
| Dyspepsia | 2.5 | 3.8 | 6.1 | 5.0 |
| Anorexia | 3.8 | 3.2 | 8.6 | 3.8 |
| Diarrhea | 5.5 | 2.9 | 9.0 | 3.1 |
| Flatulence | 2.5 | 2.6 | 2.0 | 1.9 |
| Stomatitis | 0.8 | 1.0 | 1.2 | 0.0 |
| Tooth disorder | 0.0 | 1.0 | 1.2 | 0.3 |
| Oral Moniliasis | 0.4 | 0.6 | 1.2 | 0.3 |
| Nervous | ||||
| Hypertonia | 5.9 | 6.1 | 5.3 | 5.9 |
| Depression | 4.2 | 4.5 | 6.1 | 5.0 |
| Dizziness | 5.1 | 3.8 | 12.7 | 2.5 |
| Dry mouth | 3.0 | 3.5 | 2.0 | 3.4 |
| Insomnia | 2.1 | 3.5 | 2.9 | 3.4 |
| Somnolence | 0.8 | 1.9 | 4.1 | 1.3 |
| Vertigo | 2.5 | 1.9 | 4.5 | 0.9 |
| Circumoral paresthesia | 1.3 | 1.6 | 3.3 | 0.0 |
| Skin and Appendages | ||||
| Pruritus | 3.8 | 3.8 | 2.5 | 3.1 |
| Eczema | 0.8 | 1.6 | 1.6 | 0.6 |
| Alopecia | 0.0 | 1.0 | 1.2 | 0.6 |
| Exfoliative dermatitis | 0.0 | 0.6 | 1.2 | 0.0 |
| Respiratory | ||||
| Decreased lung function | 13.1 | 10.2 | 16.0 | 9.4 |
| Rhinitis | 8.9 | 6.4 | 7.8 | 6.3 |
| Increased cough | 2.1 | 2.6 | 3.7 | 1.6 |
| Sinusitis | 0.4 | 1.0 | 1.6 | 0.9 |
| Cardiovascular | ||||
| Hypertension | 6.8 | 5.1 | 3.3 | 4.1 |
| Tachycardia | 1.3 | 2.6 | 2.0 | 1.3 |
| Phlebitis | 0.4 | 1.0 | 0.8 | 0.3 |
| Palpitation | 0.4 | 0.6 | 1.2 | 0.9 |
| Postural hypotension | 0.8 | 0.0 | 1.6 | 0.6 |
| Metabolic and Nutritional Disorders | ||||
| Weight loss | 4.6 | 4.8 | 3.7 | 4.7 |
| Peripheral edema | 4.2 | 2.9 | 3.3 | 2.2 |
| Musculoskeletal System | ||||
| Arthralgia | 5.1 | 3.5 | 1.6 | 3.4 |
| Urogenital System | ||||
| Urinary tract infection | 2.5 | 2.6 | 4.5 | 2.2 |
| Dysuria | 0.0 | 1.0 | 1.2 | 0.3 |
Other Adverse Events Observed
Other events which occurred in more than 2% of patients treated with Rilutek 100 mg/day but equally or more frequently in the placebo group included: accidental injury, apnea, bronchitis, constipation, death, dysphagia, dyspnea, flu syndrome, heart arrest, increased sputum, pneumonia, and respiratory disorder.
The overall adverse event profile for Rilutek was similar between females and males, and was independent of age. Because the largest non-white racial subgroup was only 2% of patients exposed to Rilutek (18/794) in placebo-controlled trials, there are insufficient data to support a statement regarding the distribution of adverse experience reports by race. In ALS studies, dizziness did occur more commonly in females (11%) than in males (4%). There was not a difference between females and males in the rates of discontinuation of Rilutek for individual adverse experiences.
Other Adverse Events Observed During All Clinical Trials
Rilutek has been administered to 1713 individuals during all clinical trials, some of which were placebo-controlled. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified COSTART dictionary terminology. The frequencies presented represent the proportion of the 1713 individuals exposed to Rilutek who experienced an event of the type cited on at least one occasion while receiving Rilutek. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug.
Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare adverse events are those occurring in fewer than 1/1000 patients.
Body as a Whole: Frequent: Hostility1. Infrequent: Abscess1, sepsis1, photosensitivity reaction1, cellulitis, face edema1, hernia, peritonitis, attempted suicide, injection site reaction, chills1, flu syndrome, intentional injury, enlarged abdomen, neoplasm. Rare: Acrodynia, hypothermia, moniliasis1, rheumatoid arthritis.
Digestive System: Infrequent: Increased appetite, intestinal obstruction1, fecal impaction, gastrointestinal hemorrhage, gastrointestinal ulceration, gastritis1, fecal incontinence, jaundice, hepatitis, glossitis, gum hemorrhage1, pancreatitis, tenesmus, esophageal stenosis. Rare: Cheilitis1, cholecystitis, hematemesis, melena1, biliary pain, proctitis, pseudomembranous enterocolitis, enlarged salivary gland, tongue discoloration, tooth caries.
Nervous System: Frequent: Agitation1, tremor. Infrequent: Hallucinations, personality disorder1, abnormal thinking1, coma, paranoid reaction1, manic reaction, ataxia, extrapyramidal syndrome, hypokinesia, urinary retention, emotional lability, delusions, apathy, hypesthesia, incoordination, confusion1, convulsion, leg cramps, amnesia, dysarthria, increased libido, stupor, subdural hematoma, abnormal gait, delirium, depersonalization, facial paralysis, hemiplegia, decreased libido, myoclonus. Rare: Abnormal dreams, acute brain syndrome, CNS depression, dementia, cerebral embolism, euphoria1, hypotonia, ileus1, peripheral neuritis, psychosis1, psychotic depression, schizophrenic reaction, trismus, wristdrop.
Skin and Appendages: Infrequent: Skin ulceration, urticaria, psoriasis, seborrhea1, skin disorder, fungal dermatitis1. Rare: Anaphylactoid reaction, angioedema, contact dermatitis, erythema multiforme, furunculosis1, skin moniliasis, skin granuloma, skin nodule.
Respiratory System: Infrequent: Hiccup, pleural disorder1, asthma, epistaxis, hemoptysis, yawn, hyperventilation1, lung edema1, hypoventilation1, lung carcinoma, hypoxia, laryngitis, pleural effusion, pneumothorax1, respiratory moniliasis, stridor, interstitial lung disease, hypersensitivity pneumonitis.
Cardiovascular System: Infrequent: Syncope1, hypotension, heart failure, migraine, peripheral vascular disease, angina pectoris1, myocardial infarction1, ventricular extrasystoles, cerebral hemorrhage, atrial fibrillation1, bundle branch block, congestive heart failure, pericarditis, lower extremity embolus, myocardial ischemia1, shock1. Rare: Bradycardia, cerebral ischemia, hemorrhage, mesenteric artery occlusion, subarachnoid hemorrhage, supraventricular tachycardia1, thrombosis, ventricular fibrillation, ventricular tachycardia.
Metabolic and Nutritional Disorders: Infrequent: Gout1, respiratory acidosis, edema, thirst1, hypokalemia, hyponatremia, weight gain1. Rare: Generalized edema, hypercalcemia, hypercholesteremia.
Endocrine System: Infrequent: Diabetes mellitus, thyroid neoplasia. Rare: Diabetes insipidus, parathyroid disorder.
Hemic and Lymphatic System: Infrequent: Anemia1, leukocytosis, leukopenia, ecchymosis. Rare: Neutropenia, aplastic anemia, cyanosis, hypochromic anemia, iron deficiency anemia, lymphadenopathy, petechiae1, purpura.
Musculoskeletal System: Infrequent: Arthrosis, myasthenia1, bone neoplasm. Rare: Bone necrosis, osteoporosis, tetany.
Special Senses: Infrequent: Amblyopia, ophthalmitis. Rare: Blepharitis, cataract, deafness, diplopia1, ear pain, glaucoma, hyperacusis, photophobia, taste loss, vestibular disorder.
Urogenital System: Infrequent: Urinary urgency, urine abnormality, urinary incontinence, kidney calculus, hematuria, impotence, prostate carcinoma, kidney pain, metrorrhagia, priapism. Rare: Amenorrhea, breast abscess, breast pain, nephritis1, nocturia, pyelonephritis, enlarged uterine fibroids, uterine hemorrhage, vaginal moniliasis.
Laboratory Tests: Infrequent: Increased gamma glutamyl transferase, abnormal liver function/tests, increased alkaline phosphatase, positive direct Coombs test, increased gamma globulins. Rare: increased lactic dehydrogenase.
- 1
- = AE frequency ≤ to placebo
Side Effects by Body System
Hepatic
Hepatic side effects including elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and jaundice have been reported.
At least one elevation in ALT has occurred in 50% of patients receiving riluzole. An ALT greater than 5 times the upper limit of normal has occurred in approximately 2% of patients. These elevations tend to occur within the first 3 months of treatment, are usually transient if less than 5 times the upper limit of normal, and may return to normal within 2 to 6 months if therapy is continued. There is little experience in the management of patients whose ALT exceeds 5 times the upper limit of normal. The manufacturer recommends discontinuing the drug if ALT exceeds 10 times the upper limit of normal or if jaundice occurs.
In one patient receiving riluzole for epilepsy and concurrently taking phenobarbital and carbamazepine, clinical jaundice developed four months after starting riluzole (ALT 26 X ULN, AST 17 X ULN, and bilirubin 11 X ULN). Liver function tests returned to normal 7 weeks after discontinuing riluzole therapy.
Gastrointestinal
Gastrointestinal side effects have included nausea (16.3%), abdominal pain (5.1%), vomiting (4.2%), anorexia (3.2%), and diarrhea (2.9%). Two cases of pancreatitis have also been reported.
Most gastrointestinal side effects have been dose-related. Nausea and abdominal pain commonly resulted in discontinuation of riluzole during clinical trials.
Musculoskeletal
Musculoskeletal side effects including asthenia (which appears to be dose-related) (19.2%) and muscle stiffness have been reported.
Nervous system
Nervous system side effects appear to be dose-related. Dizziness occurred more frequently in female patients.
Nervous system side effects including dizziness (3.8%), vertigo (1.9%), circumoral paresthesias (1.6%) and somnolence (1.9%) have been reported.
Hematologic
Hematologic side effects including anemia and neutropenia (absolute neutrophil count less than 500/mm3) have rarely been reported. A case of methemoglobinemia has also been reported.
Cardiovascular
Cardiovascular side effects including mild to moderate increases in blood pressure have been reported.
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