What the label lists and what reports show
Bisoprolol and hydrochlorothiazide side effects
Bisoprolol and hydrochlorothiazide's FDA label: “Bisoprolol Fumarate In clinical trials, the most frequently reported laboratory change was an increase in serum triglycerides, but this was not a consistent finding.” FAERS holds 614 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 headache (50 reports).
- Generic listed
Check it at the source: the bisoprolol and hydrochlorothiazide FDA label on DailyMed (effective August 11, 2026, Teva Pharmaceuticals USA, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsBisoprolol Fumarate In clinical trials, the most frequently reported laboratory change was an increase in serum triglycerides, but this was not a consistent finding.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Placebo b (n=144) % | B2.5-40/H6.25 b (n=252) % | Placebo b (n=144) % | B2.5-10/H6.25 b (n=221) % |
|---|---|---|---|---|
| bradycardia | 0.7 | 1.1 | 0.7 | 0.9 |
| arrhythmia | 1.4 | 0.4 | 0.0 | 0.0 |
| peripheral ischemia | 0.9 | 0.7 | 0.9 | 0.4 |
| chest pain | 0.7 | 1.8 | 0.7 | 0.9 |
| bronchospasm | 0.0 | 0.0 | 0.0 | 0.0 |
| cough | 1.0 | 2.2 | 0.7 | 1.5 |
| rhinitis | 2.0 | 0.7 | 0.7 | 0.9 |
| URI | 2.3 | 2.1 | 0.0 | 0.0 |
| asthenia | 0.0 | 0.0 | 0.0 | 0.0 |
| fatigue | 2.7 | 4.6 | 1.7 | 3.0 |
| peripheral edema | 0.7 | 1.1 | 0.7 | 0.9 |
| dizziness | 1.8 | 5.1 | 1.8 | 3.2 |
| headache | 4.7 | 4.5 | 2.7 | 0.4 |
| muscle cramps | 0.7 | 1.2 | 0.7 | 1.1 |
| myalgia | 1.4 | 2.4 | 0.0 | 0.0 |
| insomnia | 2.4 | 1.1 | 2.0 | 1.2 |
| somnolence | 0.7 | 1.1 | 0.7 | 0.9 |
| loss of libido | 1.2 | 0.4 | 1.2 | 0.4 |
| impotence | 0.7 | 1.1 | 0.7 | 1.1 |
| diarrhea | 1.4 | 4.3 | 1.2 | 1.1 |
| nausea | 0.9 | 1.1 | 0.9 | 0.9 |
| dyspepsia | 0.7 | 1.2 | 0.7 | 0.9 |
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.
From the label: adverse reactions, continuedBisoprolol Fumarate and Hydrochlorothiazide Tablets Bisoprolol fumarate/HCTZ 6.25 mg is well tolerated in most patients. Most adverse effects (AEs) have been mild and transient. In more than 65,000 patients treated worldwide with bisoprolol fumarate, occurrences of bronchospasm have been rare. Discontinuation rates for AEs were similar for bisoprolol fumarate/HCTZ 6.25 mg and placebo-treated patients. In the United States, 252 patients received bisoprolol fumarate (2.5, 5, 10, or 40 mg)/HCTZ 6.25 mg and 144 patients received placebo in two controlled trials. In Study 1, bisoprolol fumarate 5/HCTZ 6.25 mg was administered for 4 weeks. In Study 2, bisoprolol fumarate 2.5, 10, or 40/HCTZ 6.25 mg was administered for 12 weeks.
Source: FDA drug label, Teva Pharmaceuticals USA, Inc., effective August 11, 2026 (SPL set 27d52b23-e3e2-4339-b00e-cd0fec43ffbb), via openFDA; the full label on DailyMed
What do FAERS reports show?
614 reports list bisoprolol and hydrochlorothiazide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 53 are coded as a death and 262 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 20 reactions below, 14 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bisoprolol and hydrochlorothiazide: 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