Drug Safety Information for EXTRA-STRENGTH AIM (Sodium monofluorophosphate)

Adverse Drug Reactions for EXTRA-STRENGTH AIM* (Sodium monofluorophosphate)

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 EXTRA-STRENGTH AIM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea256
2Vomiting243
3Pyrexia214
4Dyspnoea210
5Diarrhoea208
6Anaemia180
7Renal failure acute159
8Pneumonia154
9Fatigue152
10Hypotension148
11Pain139
12Asthenia133
13Malaise125
14Dehydration122
15Dizziness121
16Haemoglobin decreased121
17Drug ineffective115
18Decreased appetite112
19Rash111
20Renal failure111

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

Top 10 Reasons for Taking EXTRA-STRENGTH AIM
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication2511
2Constipation611
3Prophylaxis360
4Colonoscopy286
5Dry mouth256
6Osteoporosis193
7Rheumatoid arthritis149
8Dental cleaning95
9Plasmapheresis94
10Sensitivity of teeth93

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


Types of Adverse Events for EXTRA-STRENGTH AIM

Total Reports Filed with FDA: 23045


Number of FDA Adverse Event Reports by Patient Age for EXTRA-STRENGTH AIM

Total Reports Filed with FDA: 23045*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sodium monofluorophosphate (Extra-strength aim, Regular, Biotene, Aim clinical, Amerfresh, Anti e-sirin, Apatite, Cavity protection, Clean and gentle, Cool ice, Denblan, Dental guardian, Dr. fresh oral care, Dr. fresh travel, E enzyme, Firefly pediatric, Go smile, Iodent fluoride mint, Level anticavity, Mckesson fluoride, Myntsmile, Natures gum balm, Nbf gingival, Newchito plus one, New doctor ag plus, Nuga tourcia, Plus white xtra, Sirinmedi one, Smartmouth, Vita fresh, Zohar toothpaste, Sparklefresh, Bee smart, Colgate optic white, Dawnmist fluoride, Esirin x, Glo science, Glo scinece, Medichoice fluoride, Navi amazon propol, Truly whitening, Dt fluoride, Beepropolis, Business class kit, Charm tex fluoride, Esopinio topaz phyto, First class kit, In-7-one, Morning fresh, Ology fluoride, Smarth, Topco, Us airways ron kit, Colgate toothpaste, Power white, Kroger company, Supersmile)

Charts are based on 23045 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 EXTRA-STRENGTH AIM 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.