What the label lists and what reports show
Bisoprolol side effects
Bisoprolol's FDA label lists its adverse reactions in its own words. FAERS holds 135,060 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 dyspnoea (9,172 reports).
- Generic listed
Check it at the source: the bisoprolol FDA label on DailyMed (effective March 11, 2026, Micro Labs Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsSafety data are available in more than 30,000 patients or volunteers. Frequency estimates and rates of withdrawal of therapy for adverse events were derived from two U.S. placebo-controlled studies. In Study A, doses of 5, 10, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5 to 20 mg of bisoprolol fumarate; 132 received placebo. Withdrawal of therapy for adverse events was 3.3% for patients receiving bisoprolol fumarate and 6.8% for patients on placebo. Withdrawals were less than 1% for either bradycardia or fatigue/lack of energy. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Placebo (n=132) % | 5-20 mg (n=273) % | 2.5-40 mg (n=404) % |
|---|---|---|---|
| Skin increased sweating | 1.5 | 0.7 | 1.0 |
| Musculoskeletal arthralgia | 2.3 | 2.2 | 2.7 |
| Autonomic Nervous System dry mouth | 1.5 | 0.7 | 1.3 |
| Heart Rate/Rhythm bradycardia | 0 | 0.4 | 0.5 |
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, Micro Labs Limited, effective March 11, 2026 (SPL set c3ee566c-74c4-45f4-a947-526a7313e326), via openFDA; the full label on DailyMed
What do FAERS reports show?
135,060 reports list bisoprolol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 14,918 are coded as a death and 74,816 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, 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: 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