Drug Safety Information for FEMARA (Letrozole)
Safety-related Labeling Changes for FEMARA (LETROZOLE) Rx Drug: FDA Link
Safety-related Labeling Changes for KISQALI FEMARA CO-PACK (COPACKAGED) (LETROZOLE; RIBOCICLIB SUCCINATE) Rx Drug: FDA Link
Adverse Drug Reactions for FEMARA* (Letrozole)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with FEMARA
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Arthralgia* | 654 |
2 | Neoplasm malignant | 637 |
3 | Fatigue* | 526 |
4 | Pain* | 492 |
5 | Death | 484 |
6 | Nausea | 456 |
7 | Osteonecrosis | 413 |
8 | Breast cancer | 409 |
9 | Dyspnoea | 396 |
10 | Diarrhoea | 340 |
11 | Headache | 313 |
12 | Dizziness | 309 |
13 | Pain in extremity* | 306 |
14 | Fall | 300 |
15 | Osteonecrosis of jaw | 292 |
16 | Bone pain | 279 |
17 | Asthenia | 277 |
18 | Metastases to bone | 273 |
19 | Vomiting | 270 |
20 | Back pain | 269 |
* This side effect also appears in "Top 10 Side Effects of FEMARA " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking FEMARA
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Breast cancer* | 13330 |
2 | Product used for unknown indication | 2666 |
3 | Breast cancer metastatic* | 2004 |
4 | Breast cancer female | 546 |
5 | Neoplasm malignant* | 422 |
6 | Breast cancer recurrent | 260 |
7 | Breast cancer stage iv | 160 |
8 | Metastases to bone | 149 |
9 | Ovulation induction | 102 |
10 | Breast cancer stage ii* | 87 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for FEMARA
Total Reports Filed with FDA: 48535
Number of FDA Adverse Event Reports by Patient Age for FEMARA
Total Reports Filed with FDA: 48535*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Letrozole (Cgs 20267, Femara, Letrozole)
Charts are based on 48535 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
Click to go back to search results and FEMARA Reviews and Review Summary .
Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.