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Tiglutik

Last reviewed on RxList: 5/26/2020
Tiglutik Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Tiglutik?

Tiglutik (riluzole) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

What Are Side Effects of Tiglutik?

Common side effects of Tiglutik include:

Dosage for Tiglutik

The recommended dosage of Tiglutik is 50 mg (10 mL), twice daily, taken orally, every 12 hours. Take at least 1 hour before or 2 hours after a meal.

What Drugs, Substances, or Supplements Interact with Tiglutik?

Tiglutik may interact with ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton, allopurinol, methyldopa, and sulfasalazine. Tell your doctor all medications and supplements you use.

Tiglutik During Pregnancy and Breastfeeding

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

Additional Information

Our Tiglutik (riluzole) Oral Suspension 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.

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Tiglutik Professional Information

SIDE EFFECTS

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

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 50 mg twice daily [see Clinical Studies]. The most common adverse reactions in 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 riluzole group were nausea, abdominal pain, constipation, and elevated ALT.

There was no difference in the rate of adverse reactions leading to discontinuation between 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 are insufficient data to assess racial differences in the adverse reaction profile.

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 on placebo.

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

  Riluzole Tablets
50 mg twice daily
(N=313)
Placebo
(N=320)
Asthenia 19% 12%
Nausea 16% 11%
Decreased lung function 10% 9%
Hypertension 5% 4%
Abdominal pain 5% 4%
Vomiting 4% 2%
Arthralgia 4% 3%
Dizziness 4% 3%
Dry mouth 4% 3%
Insomnia 4% 3%
Pruritus 4% 3%
Tachycardia 3% 1%
Flatulence 3% 2%
Increased cough 3% 2%
Peripheral edema 3% 2%
Urinary Tract Infection 3% 2%
Circumoral paresthesia 2% 0%
Somnolence 2% 1%
Vertigo 2% 1%
Eczema 2% 1%

Additional Adverse Reactions With TIGLUTIK

In an open-label pharmacokinetic study in healthy subjects (n=36), oral hypoesthesia was observed in 29% of subjects taking TIGLUTIK, compared to 6% in patients taking riluzole tablets, under fasting conditions.

Postmarketing Experience

The following adverse reactions have been identified during post-approval 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

Read the entire FDA prescribing information for Tiglutik (Riluzole Oral Suspension)

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

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