ACORAMIDIS: 234 Adverse Event Reports & Safety Profile
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Drug Class: Cytochrome P450 2C9 Inhibitors [MoA] · Route: ORAL · Manufacturer: BridgeBio Pharma, Inc. · FDA Application: 216540 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
Patent Expires: May 5, 2031 · First Report: 20150511 · Latest Report: 20250914
What Are the Most Common ACORAMIDIS Side Effects?
All ACORAMIDIS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Diarrhoea | 67 | 28.6% | 0 | 6 |
| Abdominal discomfort | 22 | 9.4% | 0 | 1 |
| Nausea | 16 | 6.8% | 0 | 1 |
| Blood creatinine increased | 15 | 6.4% | 0 | 3 |
| Fatigue | 14 | 6.0% | 0 | 1 |
| Acute kidney injury | 13 | 5.6% | 3 | 13 |
| Asthenia | 12 | 5.1% | 2 | 4 |
| Abdominal pain | 11 | 4.7% | 0 | 1 |
| Dizziness | 11 | 4.7% | 0 | 2 |
| Abdominal pain upper | 10 | 4.3% | 0 | 0 |
| Decreased appetite | 9 | 3.9% | 0 | 1 |
| Product dose omission issue | 9 | 3.9% | 0 | 2 |
| Fall | 8 | 3.4% | 1 | 5 |
| Arthralgia | 7 | 3.0% | 0 | 1 |
| Back pain | 7 | 3.0% | 0 | 1 |
| Cardiac failure | 7 | 3.0% | 1 | 4 |
| Dyspepsia | 7 | 3.0% | 0 | 0 |
| Dysphagia | 7 | 3.0% | 0 | 1 |
| Dyspnoea | 7 | 3.0% | 0 | 3 |
| Rash | 7 | 3.0% | 1 | 1 |
Who Reports ACORAMIDIS Side Effects? Age & Gender Data
Gender: 18.3% female, 81.7% male. Average age: 79.6 years. Most reports from: US. View detailed demographics →
Is ACORAMIDIS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2015 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 1 |
| 2020 | 1 | 0 | 1 |
| 2022 | 2 | 1 | 2 |
| 2023 | 9 | 0 | 9 |
| 2024 | 15 | 3 | 8 |
| 2025 | 73 | 3 | 8 |
What Is ACORAMIDIS Used For?
| Indication | Reports |
|---|---|
| Cardiac amyloidosis | 93 |
| Product used for unknown indication | 74 |
| Amyloidosis | 38 |
| Acquired attr amyloidosis | 6 |
ACORAMIDIS vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Cytochrome P450 2C9 Inhibitors [MoA]
Official FDA Label for ACORAMIDIS
Official prescribing information from the FDA-approved drug label.
Drug Description
ATTRUBY contains 356 mg acoramidis equivalent to 400 mg acoramidis HCl. Acoramidis HCl is a transthyretin stabilizer. The chemical name of acoramidis HCl is 3-[3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy]-4-fluorobenzoic acid hydrochloride. The molecular formula is C 15 H 18 FN 2 O 3 Cl, and the molecular weight is 328.77 g/mol. The structural formula is: Acoramidis HCl is a white to tan solid. The solubility of acoramidis is ≥ 12 micrograms/mL from pH 1.2 to 6.8 in aqueous media. ATTRUBY is supplied as a white, film-coated, oval tablet, contains 356 mg acoramidis, printed with the BridgeBio company logo followed by “ACOR” in black ink on one side. The inactive ingredients are croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film coating and printing ink contain black iron oxide, glyceryl monocaprylocaprate, hypromellose, polyvinyl alcohol, propylene glycol, talc, titanium dioxide, and vinyl alcohol graft copolymer.
Structural
Formula
FDA Approved Uses (Indications)
AND USAGE ATTRUBY is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. ATTRUBY is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. ( 1 , 2.1 )
Dosage & Administration
AND ADMINISTRATION The recommended dosage of ATTRUBY is 712 mg orally twice daily. ( 2.1 )
2.1 Recommended Dosage The recommended dosage of ATTRUBY is 712 mg orally twice daily (with or without food). Swallow tablets whole; do not cut, crush, or chew.
Contraindications
None. None. ( 4 ) To report SUSPECTED ADVERSE REACTIONS, contact BridgeBio Pharma Inc. at 1-844-550-2246 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Known Adverse Reactions
REACTIONS
6.1 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. The safety data reflect the exposure of 421 participants with ATTR-CM to ATTRUBY 712 mg (administered as two 356 mg tablets) administered orally twice daily in a randomized, double-blind, placebo-controlled trial of 30 months fixed treatment duration. The median duration of exposure to ATTRUBY in the safety population was 29 months. There was a higher frequency of gastrointestinal (GI) adverse reactions such as diarrhea 11.6% versus 7.6% and upper abdominal pain 5.5% versus 1.4% in the ATTRUBY versus placebo group, respectively. The majority of these GI adverse reactions were categorized as mild and resolved without drug discontinuation. A similar proportion of ATTRUBY-treated and placebo-treated participants discontinued study drug because of an adverse event (9.3% and 8.5%, respectively).
Laboratory Tests
Increase in Serum Creatinine and Decrease in eGFR Initiation of ATTRUBY causes an increase in serum creatinine and decrease in eGFR which generally occurs within 4 weeks of starting therapy and stabilizes. In a trial of adults with ATTR-CM, a mean increase in serum creatinine of 0.2 and 0.0 mg/dL and a mean decrease in eGFR of 8.2 and 0.7 mL/min/1.73 m 2 was observed in the ATTRUBY and placebo groups, respectively, at Day 28. The changes in serum creatinine and eGFR were reversible after treatment discontinuation.
Drug Interactions
INTERACTIONS UDP-glucuronosyltransferases (UGT) Inducers and Strong CYP3A Inducers Acoramidis is metabolized by UGT enzyme-mediated glucuronidation. Concomitant use of UGT inducers can potentially decrease acoramidis exposure. While acoramidis is not metabolized by CYP3A, strong CYP3A inducers can also induce UGT enzymes. Avoid concomitant use of ATTRUBY with UGT inducers and strong CYP3A inducers.
Sensitive
Cytochrome P450 2C9 (CYP2C9) substrates Acoramidis inhibits CYP2C9 and may result in an increase in CYP2C9 substrate concentrations when these drugs are co administered. Consider more frequent monitoring of patients for evidence of increased exposure (for example, signs of exposure related toxicity) when ATTRUBY is co administered with sensitive CYP2C9 substrates.