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OFF LABEL USE side effect

What is OFF LABEL USE ?
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Drugs associated with OFF LABEL USE

ACETAMINOPHEN  ADARTREL  ADDERALL  ADVAIR  ALTABAX  ARAVA  ARIMIDEX  ARIXTRA  AVANDIA  AVASTIN  AVELOX  AVODART  BIPERIDEN  CLOBETASOL  CLOMID  CONIVAPTAN  COREG  CUBICIN  CYTOTEC  DAIVOBET  DANOL  DAYTRANA  DIPRIVAN  DOXIL  DURAGESIC  DUROGESIC  EFAVIRENZ  ENBREL  ERTACZO  FENTANYL  FINIBAX  FLAGYL  FLIXOTIDE  FLONASE  FORTEO  FORTUM  FOSAMAX  HEXABRIX  IMITREX  INVANZ  ISOTRETINOIN  ITRIZOLE  KENALOG  KETOCONAZOLE  LANTUS  LEVAQUIN  LOTRONEX  LOVAZA  LYRICA  MISOPROSTOL  NEURONTIN  OLMESARTAN  OMACOR  ORENCIA  ORTHO  PENTASA  PROGRAF  PROPRANOLOL  REBIF  RISPERDAL  RISPERIDONE  RYTHMOL  SEROQUEL  SIMDAX  SINGULAIR  STROMECTOL  TOPAMAX  TRACLEER  TYLENOL  VALTREX  VELCADE  VENTAVIS  VERAMYST  VERAPAMIL  VYVANSE  WELLBUTRIN  ZANAFLEX  ZEVALIN  


OFF LABEL USE : Lantus Side Effects Report #5661627-2
Consumer or non-health professional from BRAZIL reported LANTUS problem on Mar 06, 2008. Male patient, 76 years of age, weighting 172.0 lb, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: off label use, somnolence, . LANTUS dosage: unknown. During the same period patient was treated with HUMALOG, PLAVIX, ANCORON, ALLOPURINOL, PROSCAR, DIGOXIN, LIPITOR, SERETIDE. Patient recovered.

OFF LABEL USE : Ortho Side Effects Report #5683825-4
ORTHO EVRA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 17, 2008. Female patient, weighting 200.0 lb, was diagnosed with menometrorrhagia and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, peripheral ischaemia, venous thrombosis, . ORTHO EVRA dosage: unknown. During the same period patient was treated with ALTACE, PROTONIX. Patient was hospitalized. Patient recovered.

OFF LABEL USE : Ortho Side Effects Report #5621285-X
Consumer or non-health professional from UNITED STATES reported ORTHO EVRA problem on Jan 31, 2008. Female patient, 22 years of age, was diagnosed with menorrhagia and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, vaginal haemorrhage, withdrawal bleed, . ORTHO EVRA dosage: unknown. Patient recovered.

OFF LABEL USE : Ortho Side Effects Report #5622944-5
ORTHO EVRA problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 01, 2008. Female patient was diagnosed with dysmenorrhoea and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pleural effusion, respiratory failure, . ORTHO EVRA dosage: unknown. Patient died on 07/15/2005.

OFF LABEL USE : Lyrica Side Effects Report #5623545-5
Physician from FRANCE reported LYRICA problem on Feb 01, 2008. Female patient was diagnosed with fibromyalgia and was treated with LYRICA. After drug was administered, patient experienced the following problems/side effects: off label use, syncope vasovagal, . LYRICA dosage: unknown. Patient was hospitalized. Patient recovered.

OFF LABEL USE : Simdax Side Effects Report #5628489-0
SIMDAX problem was reported by a Physician from SPAIN on Feb 11, 2008. Male patient, child 2 years of age, was diagnosed with congestive cardiomyopathy and was treated with SIMDAX. After drug was administered, patient experienced the following problems/side effects: off label use, ventricular tachycardia, . SIMDAX dosage: unknown. During the same period patient was treated with DOPAMINA, MILRINONA. Patient recovered.

OFF LABEL USE : Avelox Side Effects Report #5629489-7
Pharmacist from UNITED STATES reported AVELOX problem on Jan 31, 2008. Female patient was treated with AVELOX. After drug was administered, patient experienced the following problems/side effects: off label use, . AVELOX dosage: unknown. Patient recovered.

OFF LABEL USE : Ortho Side Effects Report #5630195-3
ORTHO EVRA problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 06, 2008. Female patient, weighting 72.53 lb, was diagnosed with dysmenorrhoea and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pleural effusion, respiratory failure, . ORTHO EVRA dosage: unknown. Patient died on 07/15/2005.

OFF LABEL USE : Duragesic Side Effects Report #5632738-2
Consumer or non-health professional from UNITED STATES reported DURAGESIC problem on Feb 12, 2008. Male patient, 17 years of age, was diagnosed with toothache and was treated with DURAGESIC. After drug was administered, patient experienced the following problems/side effects: off label use, unevaluable event, . DURAGESIC dosage: unknown. Patient died.

OFF LABEL USE : Duragesic Side Effects Report #5634388-0
DURAGESIC problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 12, 2008. Male patient, weighting 120.0 lb, was diagnosed with pain in extremity and was treated with DURAGESIC. After drug was administered, patient experienced the following problems/side effects: off label use, overdose, . DURAGESIC dosage: unknown. During the same period patient was treated with TYLENOL. Patient was hospitalized. Patient died on 01/27/1993.

OFF LABEL USE : Clomid Side Effects Report #5640620-X
Pharmacist from UNITED KINGDOM reported CLOMID problem on Feb 18, 2008. Male patient was treated with CLOMID. After drug was administered, patient experienced the following problems/side effects: off label use, overdose, renal failure acute, . CLOMID dosage: unknown. Patient recovered.

OFF LABEL USE : Fentanyl Side Effects Report #5640768-X
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 16, 2008. Male patient, 23 years of age, weighting 150.0 lb, was diagnosed with procedural pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: off label use, procedural pain, surgery, . FENTANYL dosage: unknown. Patient was hospitalized. Patient recovered.

OFF LABEL USE : Adartrel Side Effects Report #5583070-7
Health Professional from UNITED KINGDOM reported ADARTREL problem on Jan 03, 2008. Male patient was diagnosed with parkinson's disease and was treated with ADARTREL. After drug was administered, patient experienced the following problems/side effects: off label use, parkinson's disease, . ADARTREL dosage: 2MG PER DAY. During the same period patient was treated with REQUIP. Patient recovered.

OFF LABEL USE : Ortho Side Effects Report #5588908-5
ORTHO EVRA problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 04, 2008. Female patient, weighting 200.0 lb, was diagnosed with menometrorrhagia and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, peripheral ischaemia, venous thrombosis, . ORTHO EVRA dosage: unknown. During the same period patient was treated with ALTACE, PROTONIX. Patient was hospitalized. Patient recovered.

OFF LABEL USE : Avastin Side Effects Report #5606866-1
Health Professional from UNITED KINGDOM reported AVASTIN problem on Jan 14, 2008. Female patient, 41 years of age, was diagnosed with glaucoma and was treated with AVASTIN. After drug was administered, patient experienced the following problems/side effects: off label use, toe amputation, . AVASTIN dosage: 2.5 MG, UNK. Patient recovered.

OFF LABEL USE : Enbrel Side Effects Report #5610695-2
ENBREL problem was reported by a Consumer or non-health professional from IRELAND on Jan 30, 2008. Female patient was treated with ENBREL. After drug was administered, patient experienced the following problems/side effects: off label use, . ENBREL dosage: unknown. Patient recovered.

OFF LABEL USE : Seroquel Side Effects Report #5566753-4
Consumer or non-health professional from UNITED STATES reported SEROQUEL problem on Dec 18, 2007. Female patient was treated with SEROQUEL. After drug was administered, patient experienced the following problems/side effects: off label use, . SEROQUEL dosage: unknown. Patient recovered.

OFF LABEL USE : Tracleer Side Effects Report #5574090-7
TRACLEER problem was reported by a Physician from FRANCE on Dec 14, 2007. Male patient, 68 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: off label use, pneumonia, . TRACLEER dosage: 125 MG,BID,ORAL; 62.5 MG,BID,ORAL. During the same period patient was treated with DIURETICS. Patient died on 02/01/2007.

OFF LABEL USE : Ortho Side Effects Report #5574392-4
Consumer or non-health professional from UNITED STATES reported ORTHO EVRA problem on Dec 14, 2007. Female patient was diagnosed with dysmenorrhoea and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pleural effusion, respiratory failure, . ORTHO EVRA dosage: unknown. Patient died on 07/15/2005.

OFF LABEL USE : Hexabrix Side Effects Report #5575986-2
HEXABRIX problem was reported by a Health Professional from FRANCE on Dec 17, 2007. Female patient was diagnosed with spinal myelogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: off label use, status epilepticus, . HEXABRIX dosage: unknown. Patient recovered.

OFF LABEL USE : Lovaza Side Effects Report #5588544-0
Consumer or non-health professional from UNITED STATES reported LOVAZA problem on Aug 20, 2007. Male patient, 43 years of age, was diagnosed with blood cholesterol increased and was treated with LOVAZA. After drug was administered, patient experienced the following problems/side effects: off label use, therapeutic response unexpected, . LOVAZA dosage: unknown. Patient recovered.

OFF LABEL USE : Lovaza Side Effects Report #5588919-X
LOVAZA problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 05, 2007. Male patient, 73 years of age, was diagnosed with blood cholesterol, blood triglycerides increased and was treated with LOVAZA. After drug was administered, patient experienced the following problems/side effects: off label use, onychoclasis, . LOVAZA dosage: unknown. During the same period patient was treated with TRICOR. Patient recovered.

OFF LABEL USE : Lovaza Side Effects Report #5588930-9
Consumer or non-health professional from UNITED STATES reported LOVAZA problem on Sept 21, 2007. Female patient, 62 years of age, weighting 157.0 lb, was diagnosed with blood cholesterol increased and was treated with LOVAZA. After drug was administered, patient experienced the following problems/side effects: off label use, therapeutic response unexpected, . LOVAZA dosage: unknown. During the same period patient was treated with FOLIC ACID, KLONOPIN, PROZAC, NEXIUM, CRESTOR. Patient recovered.

OFF LABEL USE : Lovaza Side Effects Report #5588936-X
LOVAZA problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 27, 2007. Female patient, 65 years of age, weighting 132.0 lb, was diagnosed with blood cholesterol increased, blood pressure and was treated with LOVAZA. After drug was administered, patient experienced the following problems/side effects: off label use, weight increased, . LOVAZA dosage: unknown. During the same period patient was treated with TOPROL, FLAXSEED OIL. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5597024-8
Physician from UNITED STATES reported VYVANSE problem on Dec 14, 2007. Male patient, 15 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, tic, . VYVANSE dosage: 50 MG, 1X/DAY:QD, ORAL ; 50 MG, 1X/DAY:QD, ORAL. During the same period patient was treated with LAMICTAL, ALBUTEROL, KLONOPIN, SINGULAIR, TENEX. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5597039-X
VYVANSE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 15, 2007. Male patient was diagnosed with disturbance in attention, energy increased and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, restlessness, . VYVANSE dosage: 50 MG. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5597225-9
Physician from UNITED STATES reported VYVANSE problem on Oct 23, 2007. Male patient, 16 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, vision blurred, . VYVANSE dosage: 30 MG, 1X/DAY:QD. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5597245-4
VYVANSE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 02, 2007. Male patient, child 5 years of age, weighting 50.04 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, tic, . VYVANSE dosage: 30 MG, 1X/DAY:QD, ORAL. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5597276-4
Health Professional from UNITED STATES reported VYVANSE problem on Nov 12, 2007. Male patient, child 5 years of age, weighting 54.90 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, vomiting, . VYVANSE dosage: 30 MG, 1X/DAY:QD, ORAL. During the same period patient was treated with SINGULAIR. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5597335-6
VYVANSE problem was reported by a Physician from UNITED STATES on Oct 05, 2007. Male patient, child 5 years of age, was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, psychotic disorder, . VYVANSE dosage: 30 MG, ORAL. During the same period patient was treated with ADDERALL. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5597764-0
Health Professional from UNITED STATES reported VYVANSE problem on Oct 02, 2007. Male patient, 45 years of age, weighting 205.0 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, vision blurred, . VYVANSE dosage: 30 MG, 1X/DAY:QD, ORAL. Patient recovered.

OFF LABEL USE : Singulair Side Effects Report #5511996-9
SINGULAIR problem was reported by a Physician from SPAIN on Oct 30, 2007. Female patient, 40 years of age, was diagnosed with asthma, nasal polyps and was treated with SINGULAIR. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary eosinophilia, . SINGULAIR dosage: unknown. During the same period patient was treated with ALBUTEROL SULPHATE. Patient recovered.

OFF LABEL USE : Arimidex Side Effects Report #5518501-1
Consumer or non-health professional from BRAZIL reported ARIMIDEX problem on Nov 07, 2007. Female patient, 65 years of age, weighting 114.6 lb, was diagnosed with ovarian cancer, bronchitis, hypertension, dyspepsia, nausea and was treated with ARIMIDEX. After drug was administered, patient experienced the following problems/side effects: off label use, vaginal haemorrhage, . ARIMIDEX dosage: unknown. During the same period patient was treated with CARDIZEM, MONOCORDIL, SOLMALGIN CARDIO, CELESTAMINE, NORVASC, OMEPRAZOLE, PLASIL. Patient recovered.

OFF LABEL USE : Ortho Side Effects Report #5526255-8
ORTHO EVRA problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 15, 2007. Female patient was diagnosed with dysmenorrhoea and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pleural effusion, respiratory failure, . ORTHO EVRA dosage: unknown. Patient died on 07/15/2005.

OFF LABEL USE : Arixtra Side Effects Report #5527355-9
Physician from GERMANY reported ARIXTRA problem on Nov 21, 2007. Female patient was diagnosed with peripheral arterial occlusive disease and was treated with ARIXTRA. After drug was administered, patient experienced the following problems/side effects: off label use, vascular occlusion, . ARIXTRA dosage: unknown. During the same period patient was treated with PLAVIX. Patient recovered.

OFF LABEL USE : Fosamax Side Effects Report #5570808-8
FOSAMAX problem was reported by a Physician from UNITED STATES on Apr 30, 2007. Female patient, 76 years of age, weighting 140.0 lb, was diagnosed with arthritis and was treated with FOSAMAX. After drug was administered, patient experienced the following problems/side effects: off label use, osteonecrosis, . FOSAMAX dosage: 70 MG/WKY/PO. During the same period patient was treated with NORVASC, TOPROL, ZOCOR, ZOLOFT. Patient recovered.

OFF LABEL USE : Arava Side Effects Report #5474391-7
Physician from TURKEY reported ARAVA problem on Sept 21, 2007. Female patient, 75 years of age, weighting 165.3 lb, was diagnosed with hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: off label use, pruritus, wound, . ARAVA dosage: unknown. During the same period patient was treated with CALCIUM WITH VITAMIN D, FOSAMAX, DELTACORTRIL, TENSINOR, COZAAR, DIAMICRON, PROSEK, HYZAAR. Patient recovered.

OFF LABEL USE : Cytotec Side Effects Report #5475222-1
CYTOTEC problem was reported by a Consumer or non-health professional from NORWAY on Sept 20, 2007. Female patient was diagnosed with abortion induced and was treated with CYTOTEC. After drug was administered, patient experienced the following problems/side effects: off label use, . CYTOTEC dosage: DAILY DOSE:.8MG-FREQ:ONCE. During the same period patient was treated with MIFEPRISTONE, CODEINE PHOSPHATE AND ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

OFF LABEL USE : Cytotec Side Effects Report #5475223-3
Consumer or non-health professional from NORWAY reported CYTOTEC problem on Sept 20, 2007. Female patient was diagnosed with abortion induced and was treated with CYTOTEC. After drug was administered, patient experienced the following problems/side effects: off label use, . CYTOTEC dosage: DAILY DOSE:.8MG-FREQ:ONCE. During the same period patient was treated with MIFEPRISTONE, CODEINE PHOSPHATE AND ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

OFF LABEL USE : Cytotec Side Effects Report #5477495-8
CYTOTEC problem was reported by a Pharmacist from UNITED KINGDOM on Sept 25, 2007. Female patient, weighting 198.4 lb, was diagnosed with abortion induced and was treated with CYTOTEC. After drug was administered, patient experienced the following problems/side effects: off label use, therapeutic response delayed, . CYTOTEC dosage: unknown. During the same period patient was treated with MIFEPRISTONE. Patient recovered.

OFF LABEL USE : Daytrana Side Effects Report #5490332-0
Consumer or non-health professional from UNITED STATES reported DAYTRANA problem on Oct 04, 2007. Male patient, child 4 years of age, weighting 42.99 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with DAYTRANA. After drug was administered, patient experienced the following problems/side effects: off label use, pneumonia, . DAYTRANA dosage: 15 MG, 1X/DAY:QD, TRANSDERMAL. During the same period patient was treated with SINGULAIR, NASONEX, ALBUTEROL, FLOVENT, STRATTERA, TENEX. Patient was hospitalized. Patient recovered.

OFF LABEL USE : Arava Side Effects Report #5499200-1
ARAVA problem was reported by a Physician from TURKEY on Oct 18, 2007. Female patient, 75 years of age, weighting 165.3 lb, was diagnosed with hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: off label use, pruritus, wound, . ARAVA dosage: unknown. During the same period patient was treated with CALCIUM WITH VITAMIN D, FOSAMAX, DELTACORTRIL, TENSINOR, COZAAR, DIAMICRON, PROSEK, HYZAAR. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5500644-X
Physician from UNITED STATES reported VYVANSE problem on Aug 02, 2007. Female patient was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, somnolence, . VYVANSE dosage: unknown. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5500664-5
VYVANSE problem was reported by a Physician from UNITED STATES on Aug 02, 2007. Female patient was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, somnolence, . VYVANSE dosage: unknown. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5500665-7
Physician from UNITED STATES reported VYVANSE problem on Aug 02, 2007. Female patient was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, somnolence, . VYVANSE dosage: unknown. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5500668-2
VYVANSE problem was reported by a Physician from UNITED STATES on Aug 02, 2007. Female patient was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, somnolence, . VYVANSE dosage: unknown. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5500670-0
Physician from UNITED STATES reported VYVANSE problem on Aug 02, 2007. Female patient was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, somnolence, . VYVANSE dosage: unknown. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5501660-4
VYVANSE problem was reported by a Consumer or non-health professional from UNITED STATES on July 25, 2007. Female patient, 16 years of age, weighting 160.1 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, rash erythematous, . VYVANSE dosage: 30 MG, 1X/DAY;QD; ORAL. During the same period patient was treated with ABILIFY, LAMICTAL, FLUOXETINE. Patient recovered.

OFF LABEL USE : Vyvanse Side Effects Report #5501671-9
Consumer or non-health professional from UNITED STATES reported VYVANSE problem on Aug 06, 2007. Male patient, 13 years of age, weighting 50.04 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, somnolence, . VYVANSE dosage: 30 MG, 1X/DAY, QD; ORAL. During the same period patient was treated with PROPRANOLOL, RISPERDAL. Patient recovered.

OFF LABEL USE : Finibax Side Effects Report #5502111-6
FINIBAX problem was reported by a Health Professional from JAPAN on Oct 19, 2007. Male patient was diagnosed with prostate cancer and was treated with FINIBAX. After drug was administered, patient experienced the following problems/side effects: off label use, prostate cancer, . FINIBAX dosage: unknown. During the same period patient was treated with HONVAN, CONCENTRATED RED CELLS, FRESH FROZEN PLASMA, OMEPRAL, LASIX. Patient died on 09/14/2007.

OFF LABEL USE : Singulair Side Effects Report #5502424-8
Physician from SPAIN reported SINGULAIR problem on Oct 23, 2007. Female patient, 41 years of age, was diagnosed with asthma, nasal polyps and was treated with SINGULAIR. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary eosinophilia, . SINGULAIR dosage: unknown. During the same period patient was treated with BUDESONIDE. Patient recovered.

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