Drug Safety Information for AMOXIL (Amoxicillin)

Safety-related Labeling Changes for AMOXIL (AMOXICILLIN) Rx Drug: FDA Link

Safety-related Labeling Changes for AUGMENTIN '250' (AMOXICILLIN; CLAVULANATE POTASSIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for AUGMENTIN '500' (AMOXICILLIN; CLAVULANATE POTASSIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for AUGMENTIN '250' (AMOXICILLIN; CLAVULANATE POTASSIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for AUGMENTIN '125' (AMOXICILLIN; CLAVULANATE POTASSIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for AUGMENTIN '875' (AMOXICILLIN; CLAVULANATE POTASSIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for AUGMENTIN '400' (AMOXICILLIN; CLAVULANATE POTASSIUM) Discontinued Drug: FDA Link

Safety-related Labeling Changes for AUGMENTIN '200' (AMOXICILLIN; CLAVULANATE POTASSIUM) Discontinued Drug: FDA Link

Safety-related Labeling Changes for AUGMENTIN '200' (AMOXICILLIN; CLAVULANATE POTASSIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for AUGMENTIN '400' (AMOXICILLIN; CLAVULANATE POTASSIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for AUGMENTIN ES-600 (AMOXICILLIN; CLAVULANATE POTASSIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for PREVPAC (AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE; LANSOPRAZOLE) Rx Drug: FDA Link

Safety-related Labeling Changes for AUGMENTIN XR (AMOXICILLIN; CLAVULANATE POTASSIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for MOXATAG (AMOXICILLIN) Discontinued Drug: FDA Link

Safety-related Labeling Changes for OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN (AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE) Rx Drug: FDA Link

Adverse Drug Reactions for AMOXIL* (Amoxicillin)

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 AMOXIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea1637
2Diarrhoea*1606
3Pyrexia1589
4Pain*1527
5Nausea*1420
6Vomiting1407
7Rash1264
8Anxiety*1131
9Pruritus1105
10Fatigue*1021
11Headache*938
12Dizziness*936
13Renal failure acute922
14Abdominal pain909
15Asthenia879
16Injury876
17Malaise856
18Drug interaction849
19Anaemia846
20Pneumonia821

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

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

Reason # of FDA Reports
1Product used for unknown indication11967
2Infection2219
3Sinusitis*2102
4Bronchitis*2095
5Helicobacter infection1999
6Urinary tract infection*1637
7Lower respiratory tract infection1557
8Upper respiratory tract infection*1540
9Prophylaxis1283
10Pneumonia*1092

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


Types of Adverse Events for AMOXIL

Total Reports Filed with FDA: 164542


Number of FDA Adverse Event Reports by Patient Age for AMOXIL

Total Reports Filed with FDA: 164542*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Amoxicillin (Utimox, Dispermox, Amoram, Augmentin, Amoxi, Polymox, Moxatag, Larotid, Penamox, Clamoxyl, Amoxicillin sodium, Amoxicillan, Flemoxin solutab, Wymox, Trimox, Amoxil, Amoxicillin)

Charts are based on 164542 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 AMOXIL 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.