Drug Safety Information for MONODOX (Doxycycline)

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

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 MONODOX (DOXYCYCLINE) 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 ORACEA (DOXYCYCLINE) Rx Drug: FDA Link

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

Adverse Drug Reactions for MONODOX* (Doxycycline)

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 MONODOX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*839
2Haemorrhage734
3Pain726
4Vomiting*615
5Headache*590
6Dyspnoea576
7Abortion incomplete552
8Dizziness*548
9Diarrhoea547
10Fatigue510
11Anxiety*489
12Anaemia484
13Pyrexia448
14Rash437
15Drug ineffective405
16Abdominal pain404
17Asthenia382
18Drug hypersensitivity346
19Depression340
20Malaise304

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

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

Reason # of FDA Reports
1Product used for unknown indication4436
2Acne*1891
3Rosacea*1327
4Urinary tract infection*732
5Infection640
6Lyme disease*588
7Lower respiratory tract infection540
8Sinusitis*442
9Malaria prophylaxis426
10Prophylaxis323

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


Types of Adverse Events for MONODOX

Total Reports Filed with FDA: 60774


Number of FDA Adverse Event Reports by Patient Age for MONODOX

Total Reports Filed with FDA: 60774*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Doxycycline (Doxy-caps, Doxal, Doxycycline calcium, Doxy, Doxychel, Nicazeldoxykit, Adoxa, Nordox, Doxycycline, Vibramycin, Monodox, Oracea)

Charts are based on 60774 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 MONODOX 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.