Miplyffa Side Effects

Generic name: arimoclomol

Medically reviewed by Drugs.com. Last updated on Nov 10, 2024.

Note: This document provides detailed information about Miplyffa.

Applies to arimoclomol: oral capsules Side Effects associated with arimoclomol. Some dosage forms listed on this page may not apply specifically to the brand name Miplyffa.

Applies to arimoclomol: oral capsules.

Side effects include:

Most common adverse reactions (≥15%): upper respiratory tract infection, diarrhea, and decreased weight.

For healthcare professionals

Applies to arimoclomol: oral capsule.

General adverse events

The most common adverse reactions associated with this drug in combination with miglustat were upper respiratory tract infection, diarrhea, and decreased weight.^[Ref]

Dermatologic

• Very common (10% or more): Urticaria (12%)
• Common (1% to 10%): Angioedema, progressive urticaria

Urticaria included 1 patient (3%) who reported urticaria alone and 2 patients (6%) who reported both urticaria and angioedema. The reactions occurred within the first 2 months of therapy.

Gastrointestinal

• Very common (10% or more): Diarrhea (23%)

Hematologic

• Frequency not reported: Thrombocytopenia

Thrombocytopenia was present at baseline in 2 patients and persisted throughout the trial. In 1 patient, thrombocytopenia developed and resolved during the trial.

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions

Hypersensitivity reactions included urticaria and angioedema.

Metabolic

• Very common (10% or more): Decreased appetite (12%)

Nervous system

• Very common (10% or more): Tremor (12%), headache (12%), seizure (12%)

Other

• Very common (10% or more): Decreased weight (15%)

Decreased weight occurred in 4 patients and resolved in 3 patients. The mean duration of decreased weight was 33 days and ranged from 22 to 60 days. In 1 patient, 2 separate instances of weight loss occurred during the trial, lasting 22 and 24 days, respectively. The mean weight loss was about 6% from baseline in all patients; use of this drug was not interrupted in any patient.

Renal

• Frequency not reported: Increased serum creatinine

Across clinical trials in patients with Niemann-Pick disease type C, healthy subjects, and patients with other diseases, serum creatinine increased about 10% to 20% compared to baseline; these increases mainly occurred during the first month of therapy, were not associated with changes in glomerular function, and were reversible upon discontinuation of therapy.

Respiratory

• Very common (10% or more): Upper respiratory tract infection (31%), lower respiratory tract infection (12%)

Upper respiratory tract infection included upper respiratory tract infection and rhinitis.

See also:

Further information

Miplyffa side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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