Drug Safety Information for MYCOBUTIN (Rifabutin)

FDA Safety-related Labeling Changes for MYCOBUTIN (RIFABUTIN) Rx Drug: Safety Information Link

Adverse Drug Reactions for MYCOBUTIN* (Rifabutin)

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 MYCOBUTIN
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Pyrexia	96
2	Drug interaction	62
3	Immune reconstitution syndrome	57
4	Neutropenia	53
5	Nausea	50
6	Mycobacterium avium complex infection	49
7	Uveitis	46
8	Anaemia	45
9	Pancytopenia	45
10	Thrombocytopenia	44
11	Diarrhoea	43
12	Vomiting	42
13	Leukopenia	39
14	Renal failure acute	37
15	Asthenia	34
16	Decreased appetite	34
17	White blood cell count decreased	33
18	Arthralgia	30
19	General physical health deterioration	28
20	Renal failure	27

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

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

	Reason	# of FDA Reports
1	Mycobacterium avium complex infection	769
2	Tuberculosis	415
3	Product used for unknown indication	322
4	Atypical mycobacterial infection	189
5	Mycobacterial infection	130
6	Pulmonary tuberculosis	121
7	Disseminated tuberculosis	105
8	Helicobacter infection	68
9	Atypical mycobacterial lymphadenitis	52
10	Lymph node tuberculosis	36

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

Types of Adverse Events for MYCOBUTIN

Total Reports Filed with FDA: 3974

Number of FDA Adverse Event Reports by Patient Age for MYCOBUTIN

Total Reports Filed with FDA: 3974*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Rifabutin (Ansatipin, Ansatipine, Rifabutin, Mycobutin)

Charts are based on 3974 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.

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.