What the label lists and what reports show
Trientine side effects
Trientine's FDA label lists its adverse reactions in its own words. FAERS holds 478 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 treatment noncompliance (32 reports).
- Generic listed
Check it at the source: the trientine FDA label on DailyMed (effective September 1, 2020, Bausch Health US LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsClinical experience with Syprine has been limited. The following adverse reactions have been reported in a clinical study in patients with Wilson’s disease who were on therapy with trientine hydrochloride: iron deficiency, systemic lupus erythematosus (see CLINICAL PHARMACOLOGY ). In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis. Syprine is not indicated for treatment of biliary cirrhosis, but in one study of 4 patients treated with trientine hydrochloride for primary biliary cirrhosis, the following adverse reactions were reported: heartburn; epigastric pain and tenderness; thickening, fissuring and flaking of the skin; hypochromic microcytic anemia; acute gastritis; aphthoid ulcers; abdominal pain; melena; anorexia; malaise; cramps; muscle pain; weakness; rhabdomyolysis. …
Table 3: Common Adverse Reactions Adverse reactions that occurred in >5% of CUVRIOR-treated patients and greater than in patients who continued to receive penicillamine. from a Clinical Study of CUVRIOR in Adult…
This table is printed in the CUVRIOR label published by Orphalan SA of June 19, 2025; the label quoted above does not print one.
| Adverse Reaction | CUVRIOR (N=26) n (%) | Penicillamine (N=27) n (%) |
|---|---|---|
| Abdominal pain Abdominal pain is composed of several similar terms | 5 (19%) | 1 (4%) |
| Change of bowel habits Includes constipation, abnormal feces, soft feces | 4 (15%) | 0 |
| Rash Rash is composed of several similar terms | 3 (12%) | 0 |
| Alopecia | 2 (8%) | 1 (4%) |
| Mood swings | 2 (8%) | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Bausch Health US LLC, effective September 1, 2020 (SPL set c34f77a7-996b-4470-b5df-d946a7fe5dbe), via openFDA; the full label on DailyMed
What do FAERS reports show?
478 reports list trientine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 28 are coded as a death and 93 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 16 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Trientine: 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