Alendronate vs Raloxifene: side effects in FDA adverse event reports
At a glance
| Alendronate | Raloxifene | |
|---|---|---|
| Drug class | – | – |
| Brand names | Alendronate Sodium | Raloxifene Hydrochloride |
| FAERS reports | 100,301 | 14,516 |
| Serious | 78% | 57% |
| Death outcome | 11,882 | 560 |
| Boxed warning | No | Yes INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep ve |
Signals both drugs share
| Reaction | Alendronate | Raloxifene | Label screen (A / B) |
|---|---|---|---|
| Fracture delayed union | 439 · PRR 223.6 | 14 · PRR 24.1 | Labeled (related wording) / Not in label — unassessed |
| Low turnover osteopathy | 3,765 · PRR 3,302.6 | 52 · PRR 18.8 | Likely indication confounding / Likely indication confounding |
| Intramedullary rod insertion | 1,972 · PRR 4,997.2 | 28 · PRR 19.7 | Not in label — unassessed / Not in label — unassessed |
| Fracture nonunion | 911 · PRR 418.3 | 19 · PRR 20.2 | Likely indication confounding / Not in label — unassessed |
Labeled signals distinctive to Alendronate
- Femur fracture — n=11,361, PRR 120.9 Labeled adverse reaction
- Duodenal ulcer perforation — n=4,964, PRR 446.5 Labeled (related wording)
- Peripheral venous disease — n=1,436, PRR 117.6 Labeled (related wording)
Labeled signals distinctive to Raloxifene
- Endometrial cancer — n=94, PRR 64.3 Labeled adverse reaction
- Muscle cramp — n=86, PRR 72.5 Labeled (related wording)
- Retinal vein thrombosis — n=54, PRR 119.6 Labeled — boxed warning
- Embolism venous — n=49, PRR 23.7 Labeled (related wording)
- Retinal vein occlusion — n=45, PRR 23.2 Labeled adverse reaction
- Retinal vascular thrombosis — n=18, PRR 51.4 Labeled (related wording)
- No adverse drug effect — n=10, PRR 21.2 Labeled (related wording)
Common questions
Which has more reported side effects, Alendronate or Raloxifene?
Alendronate has 100,301 FAERS reports and Raloxifene 14,516. 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 (78% vs 57%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Alendronate and Raloxifene share?
Both drugs carry disproportionality signals for fracture delayed union, low turnover osteopathy, intramedullary rod insertion, fracture nonunion. Shared signals often reflect a shared drug class or the condition both are used for.
Is Alendronate or Raloxifene 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.