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Rilutek

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Rilutek

Rilutek

Rilutek Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Rilutek (riluzole) is a benzothiazole drug indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Rilutek is available as a generic. Rilutek extends survival and/or time to tracheostomy. Side effects include but are not limited to: asthenia, nausea, dizziness, decreased lung function and diarrhea.

Rilutek is available as 50mg tablets; the dose is 50 mg every 12 hours. No increased benefit can be expected from higher daily doses, but adverse events are increased. There have been no clinical studies designed to evaluate the interaction of Rilutek with other drugs. As with all drugs, the potential for integration by a variety of mechanisms is a possibility. Rilutek should be prescribed with care in patients with current evidence or history of abnormal liver function. Rilutek should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women should not breast feed during treatment. The safety and efficacy of Rilutek in the pediatric population has not been done.

Our Rilutek (riluzole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Rilutek in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using riluzole and call your doctor at once if you have a serious side effect such as:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms;
  • chest discomfort, dry cough, trouble breathing;
  • cough with yellow or green mucus; or
  • stabbing chest pain, feeling short of breath.

Less serious side effects may include:

  • dizziness, spinning sensation;
  • muscle stiffness;
  • weakness, drowsiness;
  • numbness or tingly feeling in or around your mouth;
  • mild nausea, diarrhea, stomach pain, constipation;
  • headache; or
  • runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Rilutek (Riluzole) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Rilutek Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, tiredness, nausea, vomiting, diarrhea, loss of appetite, stomach pain, or numbness/tingling around the mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, chills, cough, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious signs of liver problems occur: yellowing eyes/skin, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Rilutek (Riluzole)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rilutek FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most commonly observed AEs associated with the use of RILUTEK (riluzole) 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 (riluzole) in premarketing 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 (riluzole) 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 (riluzole) (n=794) participating in placebo-controlled trials and were numerically greater in the patients treated with RILUTEK (riluzole) 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.

Table 1: Adverse Events Occurring in Placebo-Controlled Clinical Trials

Body System /
Adverse Event
Percentage of patients reporting events
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 (riluzole) 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 (riluzole) 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 (riluzole) (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 (riluzole) for individual adverse experiences.

Other Adverse Events Observed During All Clinical Trials

RILUTEK (riluzole) 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 (riluzole) who experienced an event of the type cited on at least one occasion while receiving RILUTEK (riluzole) . 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.

* = AE frequency ≤ to placebo

Body as a Whole: Frequent: Hostility*. Infrequent: Abscess*, sepsis*, photosensitivity reaction*, cellulitis, face edema*, hernia, peritonitis, attempted suicide, injection site reaction, chills*, flu syndrome, intentional injury, enlarged abdomen, neoplasm. Rare: Acrodynia, hypothermia, moniliasis*, rheumatoid arthritis.

Digestive System: Infrequent: Increased appetite, intestinal obstruction*, fecal impaction, gastrointestinal hemorrhage, gastrointestinal ulceration, gastritis*, fecal incontinence, jaundice, hepatitis, glossitis, gum hemorrhage*, pancreatitis, tenesmus, esophageal stenosis. Rare: Cheilitis*, cholecystitis, hematemesis, melena*, biliary pain, proctitis, pseudomembranous enterocolitis, enlarged salivary gland, tongue discoloration, tooth caries.

Immune System Disorders: Infrequent: Anaphylactoid reaction and anaphylaxis.

Nervous System: Frequent: Agitation*, tremor. Infrequent: Hallucinations, personality disorder*, abnormal thinking*, coma, paranoid reaction*, manic reaction, ataxia, extrapyramidal syndrome, hypokinesia, urinary retention, emotional lability, delusions, apathy, hypesthesia, incoordination, confusion*, 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, euphoria*, hypotonia, ileus*, peripheral neuritis, psychosis*, psychotic depression, schizophrenic reaction, trismus, wristdrop.

Skin and Appendages: Infrequent: Skin ulceration, urticaria, psoriasis, seborrhea*, skin disorder, fungal dermatitis*. Rare: Angioedema, contact dermatitis, erythema multiforme, furunculosis*, skin moniliasis, skin granuloma, skin nodule.

Respiratory System: Infrequent: Hiccup, pleural disorder*, asthma, epistaxis, hemoptysis, yawn, hyperventilation*, lung edema*, hypoventilation*, lung carcinoma, hypoxia, laryngitis, pleural effusion, pneumothorax*, respiratory moniliasis, stridor.

Cardiovascular System: Infrequent: Syncope*, hypotension, heart failure, migraine, peripheral vascular disease, angina pectoris*, myocardial infarction*, ventricular extrasystoles, cerebral hemorrhage, atrial fibrillation*, bundle branch block, congestive heart failure, pericarditis, lower extremity embolus, myocardial ischemia*, shock*. Rare: Bradycardia, cerebral ischemia, hemorrhage, mesenteric artery occlusion, subarachnoid hemorrhage, supraventricular tachycardia*, thrombosis, ventricular fibrillation, ventricular tachycardia.

Metabolic and Nutritional Disorders: Infrequent: Gout*, respiratory acidosis, edema, thirst*, hypokalemia, hyponatremia, weight gain*. Rare: Generalized edema, hypercalcemia, hypercholesteremia.

Endocrine System: Infrequent: Diabetes mellitus, thyroid neoplasia. Rare: Diabetes insipidus, parathyroid disorder.

Hemic and Lymphatic System: Infrequent: Anemia*, leukocytosis, leukopenia, ecchymosis. Rare: Neutropenia, aplastic anemia, cyanosis, hypochromic anemia, iron deficiency anemia, lymphadenopathy, petechiae*, purpura.

Musculoskeletal System: Infrequent: Arthrosis, myasthenia*, bone neoplasm. Rare: Bone necrosis, osteoporosis, tetany.

Special Senses: Infrequent: Amblyopia, ophthalmitis. Rare: Blepharitis, cataract, deafness, diplopia*, 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, nephritis*, 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.

* = AE frequency ≤ to placebo

Read the entire FDA prescribing information for Rilutek (Riluzole) »

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Rilutek - User Reviews

Rilutek User Reviews

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Here is a collection of user reviews for the medication Rilutek sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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