What the label lists and what reports show

Acoramidis side effects

Acoramidis's FDA label lists its adverse reactions in its own words. FAERS holds 306 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (54 reports).

No generic listed

Check it at the source: the acoramidis FDA label on DailyMed (effective June 29, 2026, BridgeBio Pharma, Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of ATTRUBY?
The most common side effects of ATTRUBY were mild and include: stomach-area (abdominal) pain diarrhea These are not all of the possible side effects of ATTRUBY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Source: FDA drug label, BridgeBio Pharma, Inc., effective June 29, 2026 (SPL set 913552ef-875d-4cb7-bf05-a7d20a394c38), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions
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. …

Source: FDA drug label, BridgeBio Pharma, Inc., effective June 29, 2026 (SPL set 913552ef-875d-4cb7-bf05-a7d20a394c38), via openFDA; the full label on DailyMed

What do FAERS reports show?

306 reports list acoramidis among the medicines taken, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 35 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

Diarrhoea (named in the label)54
Fatigue22
Dizziness19
Blood Creatinine Increased16
Nausea15
Abdominal Discomfort14
Asthenia14
Dyspnoea12
Product Dose Omission Issue (a use or a product term, not a reaction)12
Abdominal Pain Upper10
Rash10
Weight Decreased10
Dysphagia8
Wrong Technique In Product Usage Process (a use or a product term, not a reaction)8
Death (an outcome recorded in the report)7
Gastrointestinal Disorder7
Product Packaging Difficult To Open7
Product Storage Error7
Pruritus7
Dyspepsia6
Gait Disturbance6
Glomerular Filtration Rate Decreased6
Malaise6
Vomiting6
Abdominal Pain (named in the label)5

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Acoramidis: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions