New Data Shows Blood Pressure Reduction Therapy with BENICAR(R) and BENICAR HCT(R) Effectively Reduces Blood Pressure in Elderly Patients to Target Blood Pressure
... trial, occurrence of drug-related AEs included:
dizziness (3.4 percent), hypotension (2.2 percent), and/or ... of the treatment population. The most common were
dizziness (8 patients, 4.5%) diarrhea (4 patients, 2.2%), ... regimens, headache (4 patients, 2.4%) and
dizziness (4 patients, 2.4%) were reported for OM 40 mg ...
Powerful New Efficacy Data in Moderate and Severe Hypertensive Patients Supports FDA Approval of AVALIDE(R) (Irbesartan-Hydrochlorothiazide) as the First Combination Therapy for Initial Use in Patients Likely to Need Multiple Drugs to Achieve Their Blood
... syncope (0% vs. 0%),
hypotension (0.6% vs. 0%),
dizziness (3.6% vs. 4.0%), headache (4.3% vs.
6.6%), ... were:
hypotension (0.9% vs. 0% and 0%),
dizziness (3.0% vs. 3.8% and 1.0%),
headache (5.5% vs. 3.8% ... received adjunctive antihypertensives):
dizziness (10.2% vs 6.0%), ...
RAPAFLO(TM) (silodosin) Provides Rapid and Sustained Benign Prostatic Hyperplasia (BPH) Symptom Relief in as Little as Three Days
... and 1.5%, respectively). In addition, the incidence of treatment-related
dizziness was only slightly higher among RAPAFLO(TM)- than placebo-treated patients ... adverse event was dizziness. The incidence of treatment-related
dizziness was low and only slightly higher among RAPAFLO(TM) than placebo-treated ...
New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting
... that were more frequent than with placebo are nausea (28% vs. 18%),
dizziness (25% vs. 24%), somnolence (22% vs. 9%), insomnia (17% vs. 12%), asthenia ... vs. 31%), extrapyramidal syndrome (28% vs. 26%), insomnia (27% vs. 22%),
dizziness (26% vs. 25%), accidental injury (17% vs. 15%), hallucinations (17% vs. ...
Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multiple Myeloma
... and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and
dizziness (excluding vertigo) (each 17%), pain in limb and abdominal pain (each ... vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%),
dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in ...
More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies
... are pregnant, as it may cause fetal harm. Some women reported fatigue and
dizziness with Femara. Until you know how it affects you, use caution before driving ... edema (21%), malignant neoplasm aggravated (20%), headache (19%),
dizziness (excluding vertigo) (18%), insomnia (16%), decreased weight (16%), back ...
New England Journal of Medicine Publishes Phase III Results of VELCADE(R) (Bortezomib) for Injection in Previously Untreated Multiple Myeloma Patients
... vs 10%), rash (19% vs 7%), back pain (17% vs 18%),
pneumonia (16% vs 11%),
dizziness (16% vs 11%), dyspnea (15% vs 13%),
headache (14% vs 10%), pain in ... and insomnia (each 20%), rash (18%), arthralgia (17%),
neutropenia and
dizziness (excluding vertigo) (each 17%), pain in limb and
abdominal pain (each ...
New Study Shows BENICAR(R) (olmesartan medoxomil) Reverses Blood Vessel Damage Independent of Blood Pressure Lowering
... of patients treated with BENICAR and more frequently than placebo was
dizziness (3% vs 1%) -- AEs reported in > 2% of patients taking BENICAR HCT and ... than placebo included nausea (3% vs 0%), hyperuricemia (4% vs 2%),
dizziness (9% vs 2%), and upper respiratory tract infection (7% vs 0%)
Dosing and ...
New Data Shows 45 Percent of Patients with Stage 1 Hypertension Reached Normotension with BENICAR(R) and BENICAR HCT(R)
... of patients treated with BENICAR and more
frequently than placebo was
dizziness (3 percent vs 1 percent). AEs
reported in > 2 percent of patients taking ... nausea (3 percent vs 0 percent), hyperuricemia (4
percent vs 2 percent),
dizziness (9 percent vs 2 percent), and upper
respiratory tract infection (7 percent ...
U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
... 8%; placebo: 0%),
salivary hypersecretion (ABILIFY: 6%; placebo: 0%) and
dizziness (ABILIFY:
5%; placebo: 1%). Four common adverse reactions had a ... blurred vision (8% vs 0%), salivary hypersecretion (6% vs 0%), and
dizziness (5% vs 1%) -- Adult patients with agitation associated with bipolar ...
AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
... (9%-44% vs 3%-13%), sedation (30% vs
8%), somnolence (18%-28% vs 7%-8%),
dizziness (11%-18% vs 5%-7%),
constipation (8%- 10% vs 3%-4%), SGPT increase (5% vs ... 5%), dyspepsia (5% vs 2%), sedation
(13% vs 7%), somnolence (12% vs 4%),
dizziness (10% vs 4%), and orthostatic
hypotension (7% vs 5%).
In long-term ...
European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
... percent of patients reported central nervous system
symptoms (including
dizziness [28.1%], insomnia [16.3%], impaired
concentration [8.3%], somnolence ... weeks in patients receiving efavirenz + emtricitabine +
tenofovir DF were
dizziness (8%), nausea (8%), diarrhea (7%), fatigue (7%),
headache (5%), rash (5%), ...
Bristol-Myers Squibb and Gilead Sciences Expand Their Alliance to Include Commercialization of ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Europe
... percent of patients reported central nervous system
symptoms (including
dizziness [28.1%], insomnia [16.3%], impaired
concentration [8.3%], somnolence ... weeks in patients receiving efavirenz + emtricitabine +
tenofovir DF were
dizziness (8%), nausea (8%), diarrhea (7%), fatigue (7%),
headache (5%), rash (5%), ...
SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia
... (9%-44% vs 3%-13%), sedation (30% vs
8%), somnolence (18%-28% vs 7%-8%),
dizziness (11%-18% vs 5%-7%),
constipation (8%- 10% vs 3%-4%), SGPT increase (5% vs ... 5%), dyspepsia (5% vs 2%), sedation
(13% vs 7%), somnolence (12% vs 4%),
dizziness (10% vs 4%), headache (7% vs
5%), and orthostatic hypotension (7% vs 5%). ...
European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
... percent of patients reported central nervous system
symptoms (including
dizziness [28.1%], insomnia [16.3%], impaired
concentration [8.3%], somnolence ... weeks in patients receiving efavirenz + emtricitabine +
tenofovir DF were
dizziness (8%), nausea (8%), diarrhea (7%), fatigue (7%),
headache (5%), rash (5%), ...
Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
... percent of patients reported central nervous system
symptoms (including
dizziness [28.1%], insomnia [16.3%], impaired
concentration [8.3%], somnolence ... weeks in patients receiving efavirenz + emtricitabine +
tenofovir DF were
dizziness (8%), nausea (8%), diarrhea (7%), fatigue (7%),
headache (5%), rash (5%), ...
New Data Suggest Cymbalta(R) Reduced Pain in Fibromyalgia Patients With and Without Depression
... all
of their medical conditions. Patients taking Cymbalta may experience
dizziness or fainting upon
standing. The most common side effects of Cymbalta ... dry mouth and constipation -- For DPNP: Nausea, somnolence (sleepiness),
dizziness and constipation -- For GAD: Nausea, fatigue, dry mouth, somnolence ...
R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent
... 0 0% 3 2%
-------------------------------- --- --- --- ---
Diarrhea, nausea, vomiting,
dizziness 1 1% 7 5%
--------------------------- --- --- --- ---
Increase ...
Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma
... provider right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting, or symptoms of low blood pressure (such as
dizziness or faintness). If you or your child is under stress, such as with surgery, after surgery, or trauma, you may need steroids by mouth again.
...
ASMANEX(R) (Mometasone Furoate Dry Powder Inhaler) Now Approved in Japan for the Treatment of Bronchial Asthma in Adult Patients
... provider right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting, or symptoms of low blood pressure (such as
dizziness or faintness). If you or your child is under stress, such as with surgery, after surgery, or trauma, you may need steroids by mouth again.
Avoid ...
Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial
... 21 14%
Neutropenia
(ANC <1500) 1 1% 6 4% 1 1%
Diarrhea, nausea,
vomiting,
dizziness 1 1% 5 3% 9 6%
Increase in Blood
Pressure 2 1% 4 3% 6 4%
...
Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types
... to Femara or any of its ingredients. You should not take Femara if you are pregnant as it may cause fetal harm. Some women reported fatigue and
dizziness with Femara. Until you know how it affects you, use caution before driving or operating machinery. Some patients taking Femara had an increase in ...
Video: UCB Launches Vimpat(R) in the U.S. for Add-On Treatment of Epilepsy in Adults
... second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Treatment with lacosamide has been associated with
dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar ...
Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)
... vs. 10% and 34% vs. 13%), fatigue (28% vs. 21% and 33% vs. 20%), diarrhea (25% vs. 17% and 33% vs. 21%), dyspepsia (17% vs. 9% and 21% vs. 6%), and
dizziness (19% vs. 10% and 18% vs. 10%). Rash was generally mild to moderate in both studies; only 2 patients (1 in each CAPACITY study) receiving pirfenidone ...
Ongoing Landmark ROADMAP Study Demonstrates Significant Improvement in Blood Pressure Control at One Year, According to Blinded Results
... with BENICAR was similar to placebo-- The only AE that occurred in >1% of patients treated with BENICAR(R) and more frequently than placebo was
dizziness (3% vs 1%)
Dosing and Administration
No initial dosage adjustments are recommended with BENICAR in elderly or in ...
New Data Shows AZOR(R) (amlodipine and olmesartan medoxomil) Significantly Improves 24-Hour Ambulatory Blood Pressure
... treatment because of drug-related adverse events. In this trial, occurrence of drug-related AEs included: peripheral edema (2.2 percent) and
dizziness (1.1 percent).
High blood pressure can cause permanent changes to blood vessels and the heart that may create serious problems elsewhere in the ...
Generic Substitutes Less Effective/Safe Than Branded Medications in Treating Lower Urinary Tract Symptoms
... to generic medications, the IPSS and PVR rates increased and Qmax decreased. In addition, the men experienced several new side effects, including
dizziness (4.6 percent), nasal congestion (3.2 percent) and ejaculatory dysfunction (3.6 percent) for those switching alpha blockers, and ejaculatory ...
Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)
... therapy due to retrograde ejaculation were low. The second most commonly-reported adverse event was dizziness. The incidence of treatment-related
dizziness was low and only slightly higher among RAPAFLO(TM) than placebo-treated patients.
Previously presented data included information that in ...
Ascenta Therapeutics Announces Positive Preliminary Results with AT-101 in Docetaxel Refractory Prostate Cancer
... or greater) adverse events included fatigue (50 percent), diarrhea (27 percent), nausea, anorexia, and neutropenia (all 23 percent), vomiting and
dizziness (18 percent). The most common Grade 3/4 toxicity was neutropenia (23 percent) and was the only Grade 3/4 adverse event that occurred in more than ...
Video: Zometa(R) Reduces Risk of Breast Cancer Recurrence in Premenopausal Women, Study in The New England Journal of Medicine Reports
... (24%), myalgia (23%), anorexia (22%), cough (22%), arthralgia (21%), lower-limb edema (21%), malignant neoplasm aggravated (20%), headache (19%),
dizziness (excluding vertigo) (18%), insomnia (16%), decreased weight (16%), back pain (15%) and paresthesia (15%).
Caution is advised when ...
Cymbalta(R) Significantly Reduced Osteoarthritis Knee Pain in New Study
... with their doctor before stopping
Cymbalta or changing the dose and if they are pregnant or nursing.
Patients taking Cymbalta may experience
dizziness or fainting upon
standing. The most common side effects of Cymbalta include nausea, dry mouth,
sleepiness and constipation.
This is not a ...
Idenix Pharmaceuticals Initiates Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)
... evaluating doses ranging from 5 to 100 mg/day, IDX184 was safe and well-tolerated; the most common adverse event reported in this study was
dizziness and it was more frequently reported in subjects receiving placebo.
2008 Financial Guidance
Idenix today reported that it ended 2008 with ...
Video: Femara(R) First Aromatase Inhibitor to Indicate Survival Benefit Versus Tamoxifen When Taken for Five Years After Breast Cancer Surgery
... to Femara or any of its ingredients. You should not take Femara if you are pregnant as it may cause fetal harm. Some women reported fatigue and
dizziness with Femara. Until you know how it affects you, use caution before driving or operating machinery. Some patients taking Femara had an increase in ...
Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
... (n=105)
Dysgeusia 6% 17% 17%
Sedation / Somnolence 3% 7% 6%
dizziness 8% 6% 5%
Throat irritation 1% 0% 4%
Fatigue ...
Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients
... adverse reactions (greater than or equal to 5 percent
higher patient incidence in Nplate versus placebo) were Arthralgia (26
percent, 20 percent),
dizziness (17 percent, 0 percent), Insomnia (16 percent,
7 percent), Myalgia (14 percent, 2 percent), Pain in Extremity (13 percent, 5
percent) , Abdominal ...
Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study of Milnacipran for the Management of Fibromyalgia
... period of the placebo-controlled trial included nausea (37% vs. 21% placebo), constipation (15% vs. 4% placebo), hot flush (11% vs. 4% placebo),
dizziness (11% vs. 5% placebo), hyperhidrosis (8% vs. 1% placebo), palpitations (7% vs. 3% placebo), tachycardia (5% vs. 1% placebo), and hypertension (5% vs. ...
Phase III Data Demonstrate Efficacy and Tolerability of Carisbamate as an Adjunctive Therapy for Partial Onset Seizures
... was well tolerated, with minimal central nervous
system-related adverse events and a low discontinuation rate. The most common
adverse events were
dizziness and somnolence. The rate of treatment-emergent
adverse events resulting in discontinuation from carisbamate was 3% in each
study. Results showed that ...
Lilly Withdraws Application for Additional U.S. Indication for Cymbalta(R) for Chronic Pain
... their doctor before stopping
Duloxetine or changing the dose and if they are pregnant or nursing.
Patients taking Duloxetine may experience
dizziness or fainting upon
standing. The most common side effects of Duloxetine include nausea, dry
mouth, sleepiness, and constipation. This is not a complete ...
Orexigen(R) Therapeutics Presents Data on Its Proprietary Formulation of Naltrexone Sustained Release (SR) Used in Contrave(R)
... Phase 3 trials. In
study NB-301 (N=1,689 evaluable patients), the trial with dosing most
similar to the Phase 2 NB-201 trial, nausea, headache, or
dizziness were
all less frequent than in the prior Phase 2 trial, as was the overall rate
of early discontinuation due to any adverse event (13.8% versus ...
New Data Show Efficacy of Zebinix(TM) in the Treatment of Epilepsy
... to 58% of patients
with partial seizures do not achieve seizure control with current
antiepileptic drugs.(9)
Furthermore, adverse events, such as
dizziness and somnolence, are
highly prevalent with existing anti-epileptic agents and may affect as many
as 97% of patients.(10) Hence, there is a need for ...