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Adverse Event Report
Field-by-field reference
Report
Safety Report ID
6408854-4
transmissiondateformat
102
transmissiondate
25/05/2010
serious
1
seriousnessother
1
receivedateformat
102
Date Received
21/10/2009
receiptdateformat
102
Date Last Updated
06/10/2009
fulfillexpeditecriteria
1
companynumb
980108-107050098
Primary Source
reportercountry
UNITED STATES
qualification
1
Sender
senderorganization
FDA-Public Use
Receiver
-
Patient
Onset Age
88
Unit of Onset Age
years
Sex
Female
Contents
Reaction
1)
2)
Drug
1)
2)
3)
openFDA Info on Medication
4)
5)
openFDA Info on Medication
Reaction
1)
Reaction
ELECTROCARDIOGRAM QT PROLONGED
2)
Reaction
TORSADE DE POINTES
Drug
1)
drugcharacterization
1
medicinalproduct
LEVAQUIN
drugauthorizationnumb
020635
drugadministrationroute
041
drugindication
BRONCHITIS
drugtreatmentduration
5
drugtreatmentdurationunit
804
2)
drugcharacterization
2
medicinalproduct
PROCAINAMIDE HCL
drugadministrationroute
041
drugindication
ATRIAL FIBRILLATION
3)
drugcharacterization
2
medicinalproduct
ALBUTEROL
drugadministrationroute
055
drugindication
BRONCHITIS
openFDA Info on Medication
Application Number
ANDA210948, ANDA213657, ANDA211397, ANDA208804, ANDA072894, ANDA207046, ANDA2088 ...
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Brand Name
ALBUTEROL
Generic Name
ALBUTEROL SULFATE, ALBUTEROL
Manufacturers
Nivagen Pharmaceuticals Inc, Aurobindo Pharma Limited, Virtus Pharmaceuticals LL ...
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product_ndc
75834-273, 75834-274, 59651-333, 59651-334, 69543-290, 69543-291, 69238-1344, 69 ...
Show All
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Active Ingredients
ALBUTEROL SULFATE
RXCUI
197316, 197318
spl_id
5b89a3bb-e3bb-421d-89f7-f180e01a1b4d, d3cb4534-a60a-4476-928c-6eb52ac01cf8, b9cd ...
Show All
spl_set_id
b735e92d-eb1a-6fc1-e053-2995a90afce2, ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6, 3f81 ...
Show All
Package NDC
75834-273-01, 75834-274-01, 59651-333-01, 59651-333-05, 59651-334-01, 59651-334- ...
Show All
UNII
021SEF3731
4)
drugcharacterization
2
medicinalproduct
CORTICOSTEROIDS
drugindication
DRUG USE FOR UNKNOWN INDICATION
5)
drugcharacterization
2
medicinalproduct
FUROSEMIDE
drugadministrationroute
065
drugindication
DRUG USE FOR UNKNOWN INDICATION
openFDA Info on Medication
Application Number
ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ...
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Brand Name
TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ...
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Generic Name
FUROSEMIDE
Manufacturers
IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ...
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product_ndc
70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ...
Show All
Product Type
HUMAN PRESCRIPTION DRUG
RXCUI
310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ...
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spl_id
29531d06-4e7f-4e26-93d0-1d98e58966d2, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ...
Show All
spl_set_id
a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ...
Show All
Package NDC
70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ...
Show All
Route
INTRAMUSCULAR, INTRAVENOUS, ORAL
Active Ingredients
FUROSEMIDE
NUI
N0000175366, N0000175590
Physiologic/Pharmacodynamic Effect
Increased Diuresis at Loop of Henle [PE]
Established Pharmacologic Class
Loop Diuretic [EPC]
UNII
7LXU5N7ZO5
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