Exservan Side Effects Center

Last updated on RxList: 7/6/2022
Exservan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Exservan?

Exservan (riluzole) is a benzothiazole class drug used to treat amyotrophic lateral sclerosis (ALS).

What Are Side Effects of Exservan?

Common side effects of Exservan include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Exservan

The recommended dosage of Exservan is 50 mg twice daily, taken at least 1 hour before or 2 hours after a meal.

Exservan In Children

Safety and effectiveness of Exservan in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Exservan?

Exservan may interact with other medicines such as:

  • ciprofloxacin,
  • enoxacin,
  • fluvoxamine,
  • methoxsalen,
  • mexiletine,
  • oral contraceptives,
  • thiabendazole,
  • vemurafenib,
  • zileuton,
  • CYP1A2 inducers,
  • allopurinol,
  • methyldopa, and
  • sulfasalazine

Tell your doctor all medications and supplements you use and all vaccines you recently received.

Exservan During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Exservan; it may harm a fetus. It is unknown if Exservan passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Exservan (riluzole) Oral Film 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.

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.

QUESTION

The abbreviated term ADHD denotes the condition commonly known as: See Answer
Exservan Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described below and elsewhere in the labeling:

  • Hepatic Injury [see WARNINGS AND PRECAUTIONS]
  • Neutropenia [see WARNINGS AND PRECAUTIONS]
  • Interstitial Lung Disease [see WARNINGS AND PRECAUTIONS]

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.

Adverse Reactions In Controlled Clinical Trials Of Riluzole Tablets

In the placebo-controlled clinical trials in patients with ALS (Study 1 and 2), a total of 313 patients received riluzole tablets 50 mg twice daily [see Clinical Studies]. The most common adverse reactions in the riluzole-treated patients (in at least 5% of patients and more frequently than on placebo) were asthenia, nausea, decreased lung function, hypertension, and abdominal pain. The most common adverse reactions leading to discontinuation in the riluzoletreated patients were nausea, abdominal pain, constipation, and elevated ALT.

There was no difference in rates of adverse reactions leading to discontinuation in females and males. However, the incidence of dizziness was higher in females (11%) than in males (4%). The adverse reaction profile was similar in older and younger patients. There were insufficient data to determine if there were differences in the adverse reaction profile in different races.

Table 1 lists adverse reactions that occurred in at least 2% of riluzole treated patients (50 mg twice daily) in pooled Study 1 and 2, and at a higher rate than placebo.

Table 1: Adverse Reactions in Pooled Placebo-Controlled Trials (Studies 1 and 2) in Patients with ALS

RILUZOLE Tablets50 mg twice daily
(N=313) %
Placebo
(N=320) %
Asthenia1912
Nausea1611
Decreased lung function109
Hypertension54
Abdominal pain54
Vomiting42
Arthralgia43
Dizziness43
Dry mouth43
Insomnia43
Pruritus43
Tachycardia31
Flatulence32
Increased cough32
Peripheral edema32
Urinary tract infection32
Circumoral paresthesia20
Somnolence21
Vertigo21
Eczema21

Additional Adverse Reaction With EXSERVAN

In an open-label pharmacokinetic study in healthy subjects (n=32), oral hypoesthesia was observed in 38% of subjects taking EXSERVAN, compared to no subjects taking riluzole tablets, under fasting conditions.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of riluzole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Acute hepatitis and icteric toxic hepatitis [see WARNINGS AND PRECAUTIONS]
  • Renal tubular impairment
  • Pancreatitis

Read the entire FDA prescribing information for Exservan (Riluzole Oral Film)

SLIDESHOW

Brain Food Pictures: What to Eat to Boost Focus See Slideshow

© Exservan Patient Information is supplied by Cerner Multum, Inc. and Exservan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors