Drug Safety Information for TARCEVA (Erlotinib hydrochloride)

Safety-related Labeling Changes for TARCEVA (ERLOTINIB HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for TARCEVA* (Erlotinib hydrochloride)

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 TARCEVA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death13357
2Rash2702
3Diarrhoea*2338
4Neoplasm malignant1944
5Nausea1166
6Disease progression1156
7Fatigue1055
8Dyspnoea1017
9Vomiting888
10Decreased appetite876
11Off label use788
12Dehydration786
13Pneumonia771
14Asthenia752
15Incorrect dose administered683
16Anaemia645
17Pyrexia631
18Pleural effusion540
19Malaise505
20Weight decreased500

* This side effect also appears in "Top 10 Side Effects of TARCEVA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking TARCEVA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Non-small cell lung cancer17794
2Lung neoplasm malignant*12017
3Malignant respiratory tract neoplasm6926
4Product used for unknown indication5952
5Pancreatic carcinoma5481
6Lung adenocarcinoma3675
7Lung carcinoma cell type unspecified stage 02809
8Pancreatic carcinoma metastatic1294
9Adenocarcinoma pancreas1211
10Hepatic neoplasm malignant1072

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for TARCEVA

Total Reports Filed with FDA: 81385


Number of FDA Adverse Event Reports by Patient Age for TARCEVA

Total Reports Filed with FDA: 81385*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Erlotinib hydrochloride (Erlotinib , Erlotinib, Osi-774, Erlotinib hcl, Tarceva)

Charts are based on 81385 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 TARCEVA 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.