Amlodipine vs Hydrochlorothiazide: side effects in FDA adverse event reports
At a glance
| Amlodipine | Hydrochlorothiazide | |
|---|---|---|
| Drug class | – | Thiazide Diuretic |
| Brand names | Katerzia | – |
| FAERS reports | 267,918 | 144,362 |
| Serious | 77% | 67% |
| Death outcome | 29,515 | 10,118 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Amlodipine | Hydrochlorothiazide | Label screen (A / B) |
|---|---|---|---|
| Nephrogenic anaemia | 961 · PRR 20.0 | 531 · PRR 18.5 | Not in label — unassessed / Likely indication confounding |
| Hyperparathyroidism secondary | 546 · PRR 21.3 | 270 · PRR 17.2 | Not in label — unassessed / Not in label — unassessed |
| Rebound acid hypersecretion | 347 · PRR 9.9 | 263 · PRR 13.5 | Not in label — unassessed / Not in label — unassessed |
| Personality disorder | 193 · PRR 6.1 | 195 · PRR 11.5 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder | 166 · PRR 11.3 | 183 · PRR 23.6 | Not in label — unassessed / Not in label — unassessed |
| Carotid artery thrombosis | 164 · PRR 18.4 | 183 · PRR 39.5 | Not in label — unassessed / Not in label — unassessed |
| Chronic kidney disease-mineral and bone disorder | 221 · PRR 20.0 | 124 · PRR 18.8 | 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 Hydrochlorothiazide
- Vasculitis — n=630, PRR 8.2 Labeled adverse reaction
- Tension headache — n=434, PRR 16.2 Labeled (related wording)
- Respiratory symptom — n=149, PRR 8.1 Labeled (related wording)
- Pulmonary vasculitis — n=131, PRR 47.7 Labeled (related wording)
Common questions
Which has more reported side effects, Amlodipine or Hydrochlorothiazide?
Amlodipine has 267,918 FAERS reports and Hydrochlorothiazide 144,362. 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 67%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Amlodipine and Hydrochlorothiazide share?
Both drugs carry disproportionality signals for nephrogenic anaemia, hyperparathyroidism secondary, rebound acid hypersecretion, personality disorder, adjustment disorder. Shared signals often reflect a shared drug class or the condition both are used for.
Is Amlodipine or Hydrochlorothiazide 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.