Drug Safety Information for DORYX (Doxycycline hyclate)

Safety-related Labeling Changes for VIBRA-TABS (DOXYCYCLINE HYCLATE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for DORYX (DOXYCYCLINE HYCLATE) Rx Drug: FDA Link

Safety-related Labeling Changes for DORYX (DOXYCYCLINE HYCLATE) Rx Drug: FDA Link

Safety-related Labeling Changes for DORYX MPC (DOXYCYCLINE HYCLATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ACTICLATE (DOXYCYCLINE HYCLATE) Rx Drug: FDA Link

Adverse Drug Reactions for DORYX* (Doxycycline hyclate)

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 DORYX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug hypersensitivity170
2Nausea*131
3Pain120
4Dyspnoea97
5Vomiting*91
6Headache*89
7Dizziness*87
8Fatigue83
9Anxiety*81
10Rash78
11Drug ineffective70
12Diarrhoea70
13Chest pain65
14Depression*62
15Arthralgia61
16Abdominal pain55
17Asthenia53
18Pyrexia53
19Deep vein thrombosis49
20Pulmonary embolism48

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

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

Reason # of FDA Reports
1Acne*605
2Product used for unknown indication594
3Rosacea111
4Infection111
5Lyme disease*98
6Sinusitis*80
7Bronchitis*70
8Acne cystic*70
9Lower respiratory tract infection56
10Malaria prophylaxis56

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


Types of Adverse Events for DORYX

Total Reports Filed with FDA: 9030


Number of FDA Adverse Event Reports by Patient Age for DORYX

Total Reports Filed with FDA: 9030*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Doxycycline hyclate (Doxy-lemmon, Morgidox, Doxy 200, Alodox, Doxycyclate hyclate, Doxteric, Vibramycin hyclate, Acticlate, Doxychel hyclate, Ocudox, Doryx, Doxy 100, Doxycycline hyclate, Vibra-tabs, Atridox, Periostat)

Charts are based on 9030 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 DORYX 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.