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What the label lists and what reports show

Triheptanoin side effects

Triheptanoin's FDA label: “Most common adverse reactions are (≥10%): abdominal pain, diarrhea, vomiting, and nausea.” FAERS holds 528 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 vomiting (86 reports).

  • No generic listed

Check it at the source: the triheptanoin FDA label on DailyMed (effective June 10, 2025, Ultragenyx Pharmaceutical 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 DOJOLVI?

Feeding tube problems. Feeding tubes may not work as well or stop working over time when taking DOJOLVI. Do not use DOJOLVI in feeding tubes made of polyvinyl chloride (PVC). Check the feeding tube to make sure it is working properly and not breaking down. Intestinal absorption problems in patients with pancreatic insufficiency. If you have pancreatic insufficiency, consult with your healthcare provider as it may affect how well DOJOLVI works. The most common side effects of DOJOLVI include: stomach (abdominal) pain diarrhea vomiting nausea These are not all the possible side effects of DOJOLVI. Call your healthcare provider for medical advice about side effects. You may report side effects to Ultragenyx at 1-888-756-8657 or FDA at 1-800-FDA-1088.

Source: FDA drug label, Ultragenyx Pharmaceutical Inc., effective June 10, 2025 (SPL set 4cfeb8bd-143e-4dd7-bc34-b0bcda02460d), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions are (≥10%): abdominal pain, diarrhea, vomiting, and nausea.

From the label: adverse reactions, continued

Most common adverse reactions are (≥10%): abdominal pain, diarrhea, vomiting, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ultragenyx Pharmaceutical Inc. at 1-888-756-8657 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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 population included 79 patients with LC-FAOD exposed to DOJOLVI in two studies: one open-label 78-week study of DOJOLVI in 29 patients (Study 1) followed by an open-label extension study (Study 2). Twenty-four patients from Study 1 continued into Study 2. Patients ranged from 4 months to 63 years of age and the population was 52% male. Of the 79 patients, 87% were White, 5% were Black or African-American, 4% were Asian, and 4% other. The daily dosage of DOJOLVI ranged between 12% and 41% DCI (which corresponds to 0.7 g/kg/day to 6.0 g/kg/day for pediatric patients and 0.5 g/kg/day to 1.3 g/kg/day for adult patients) for a mean duration of 23 months. …

Source: FDA drug label, Ultragenyx Pharmaceutical Inc., effective June 10, 2025 (SPL set 4cfeb8bd-143e-4dd7-bc34-b0bcda02460d), via openFDA; the full label on DailyMed

What do FAERS reports show?

528 reports list triheptanoin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 68 are coded as a death and 260 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 21 reactions below, 6 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.

Reports received each year

The 25 most reported reactions

  • Vomiting (named in the label)86
  • Diarrhoea (named in the label)72
  • Rhabdomyolysis55
  • Off Label Use (a use or a product term, not a reaction)50
  • Abdominal Pain Upper (named in the label)40
  • Abdominal Discomfort (named in the label)35
  • Blood Creatine Phosphokinase Increased35
  • Death (an outcome recorded in the report)33
  • Nausea (named in the label)29
  • Gastrointestinal Disorder24
  • Hospitalisation (an outcome recorded in the report)24
  • Illness24
  • Abdominal Pain (named in the label)20
  • Metabolic Disorder19
  • Product Dose Omission Issue (a use or a product term, not a reaction)16
  • Malaise14
  • Decreased Appetite13
  • Gastroenteritis Viral13
  • Viral Infection13
  • Cardiac Disorder12
  • Cardiac Failure12
  • Dehydration12
  • Drug Intolerance12
  • Myalgia12
  • Asthenia11

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

What next?

Triheptanoin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions