Amlodipine vs Bisoprolol: side effects in FDA adverse event reports
At a glance
| Amlodipine | Bisoprolol | |
|---|---|---|
| Drug class | – | – |
| Brand names | Katerzia | Bisoprolol Fumarate |
| FAERS reports | 267,918 | 135,055 |
| Serious | 77% | 97% |
| Death outcome | 29,515 | 14,918 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Amlodipine | Bisoprolol | Label screen (A / B) |
|---|---|---|---|
| Diastolic dysfunction | 232 · PRR 6.2 | 285 · PRR 15.6 | Likely indication confounding / Not in label — unassessed |
| Carotid artery thrombosis | 164 · PRR 18.4 | 208 · PRR 49.9 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder | 166 · PRR 11.3 | 193 · PRR 26.8 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Amlodipine
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Bisoprolol
- Cardiac failure chronic — n=514, PRR 21.2 Labeled (related wording)
- Tension headache — n=431, PRR 17.2 Labeled (related wording)
Common questions
Which has more reported side effects, Amlodipine or Bisoprolol?
Amlodipine has 267,918 FAERS reports and Bisoprolol 135,055. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (77% vs 97%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Amlodipine and Bisoprolol share?
Both drugs carry disproportionality signals for diastolic dysfunction, carotid artery thrombosis, adjustment disorder. Shared signals often reflect a shared drug class or the condition both are used for.
Is Amlodipine or Bisoprolol safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.