Drug Safety Information for TETRACYCLINE HYDROCHLORIDE (Tetracycline hydrochloride)

Adverse Drug Reactions for TETRACYCLINE HYDROCHLORIDE* (Tetracycline 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 TETRACYCLINE HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug hypersensitivity428
2Nausea*116
3Pain97
4Depression87
5Vomiting*86
6Rash*85
7Headache80
8Dyspnoea78
9Fatigue76
10Dizziness*75
11Anxiety73
12Tooth discolouration68
13Diarrhoea*64
14Drug ineffective60
15Pain in extremity58
16Abdominal pain58
17Weight decreased56
18Asthenia53
19Injury51
20Back pain51

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

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

Reason # of FDA Reports
1Acne*886
2Product used for unknown indication537
3Rosacea224
4Amoebiasis125
5Infection*67
6Folliculitis59
7Rash57
8Eye infection54
9Ill-defined disorder41
10Cough40

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


Types of Adverse Events for TETRACYCLINE HYDROCHLORIDE

Total Reports Filed with FDA: 10150


Number of FDA Adverse Event Reports by Patient Age for TETRACYCLINE HYDROCHLORIDE

Total Reports Filed with FDA: 10150*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tetracycline hydrochloride (Tetraciclina, Tetracycline, Tetra, Achromycin)

Charts are based on 10150 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.

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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.