Newsemia

• October 1, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: 6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain sizeAGRANULOCYTOSISallergic reactionand hepatic enzyme elevations (mostly consistent with cholestasis severe enough to require hospitalization)angina pectoris and arrhythmiaarthralgiaarthritisblood urea nitrogen (BUN) increasediplopiadysgeusiaerectile dysfunctionerythema multiformgastritishemolytic anemiahyperglycemiaHyperhidrosishypertoniahypoesthesiahypotensionit is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In postmarketing experience with benazepriljaundiceleukocytopeniamalaisemicturition disordermuscle spasmsmyalgianeutropenia. Rare reports in association with use of amlodipine: gingival hyperplasianocturiaorthostatic symptoms and hypotensionpancreatitisparesthesiapemphigusPeripheral Neuropathyphotosensitivity reactionpruritusrenal impairmentrhinitisserum creatinine increaseskin discolorationsyncopetachycardiathere have been rare reports of Stevens-Johnson syndromethrombocytopeniaurticariavasculitisvision impairmentVisual Impairment

Updated Date: Oct 1, 2018 EST

• September 28, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: a variety of other AEsabnormal lacrimationacnealopeciaangioedema. In additionanxiety/restlessnessastheniaback/neck painBisoprolol Fumarate In clinical trials worldwidebronchitisbronchospasmchest painclaudicationcold extremitiescongestive heart failureconstipationcutaneous vasculitis. Special Senses: Visual disturbancescystitisdecreased concentration/memory. Cardiovascular: Bradycardiadecreased hearingdepressiondermatitisdiarrheadizzinessdry mouth. Musculoskeletal: Arthralgiadyspepsiadyspneadyspnea on exertion. Gastrointestinal: Gastric/epigastric/abdominal painearacheeczemaedemaexfoliative dermatitis (very rarely)flushinggastritishave been reported. While in many cases it is not known whether a causal relationship exists between bisoprolol and these AEsheadachehyperesthesiahypoesthesiahypotensionin addition to those listed aboveinsomniamalaisemuscle crampsmuscle/joint painnauseaocular pain/pressureor in postmarketing experienceorthostatic hypotensionpalpitations and other rhythm disturbancesparesthesiapeptic ulcerPeyronie’s disease (very rarely)pharyngitispolyuria. General: Fatigueprurituspsoriasispurpurarenal colicrhinitissinusitisskin irritationsleep disturbance/vivid dreamssomnolencesweatingsyncopetaste abnormalities. Metabolic: Gout. Respiratory: Asthmathey are listed to alert the physician to a possible relationship. Central Nervous System: Unsteadinesstinnitustwitching/tremor. Skin: RashURI (upper respiratory infection). Genitourinary: Decreased libido/impotencevertigovomitingweight gain

Updated Date: Sep 28, 2018 EST

• September 27, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: Aggressionalterations in blood sugar levels (see PRECAUTIONS: Laboratory Tests) Gastrointestinal: inflammatory bowel disease (see WARNINGS: Inflammatory Bowel Disease)and arthralgia (see PRECAUTIONS: Information for Patients)anemiaarthritisbleeding and inflammation of the gumscalcification of tendons and ligamentsColitisdecreases in bone mineral density (see WARNINGS: Skeletal)depressiondizzinessDose Relationship Cheilitis and hypertriglyceridemia are usually dose related. Most adverse reactions reported in clinical trials were reversible when therapy was discontinued; howeverdrowsinessedemaelevations of CPK/rare reports of rhabdomyolysis (see PRECAUTIONS: Laboratory Tests) Neurological: pseudotumor cerebri (see WARNINGS: Pseudotumor Cerebri)emotional instability Of the patients reporting depressionesophagitis/esophageal ulcerationfatigueheadachehepatitis (see WARNINGS: Hepatotoxicity)ileitisincluding vasculitisinsomnialethargylymphadenopathymalaisemusculoskeletal symptoms (sometimes severe) including back painmyalgianauseanervousnessneutropeniaother nonspecific gastrointestinal symptoms Hematologic: allergic reactions (see PRECAUTIONS: Hypersensitivity)other types of bone abnormalitiespancreatitis (see WARNINGS: Lipids)paresthesiaspremature epiphyseal closurePsychosisrare reports of agranulocytosis (see PRECAUTIONS: Information for Patients). See PRECAUTIONS: Laboratory Tests for other hematological parameters. Musculoskeletal: skeletal hyperostosisseizuressome persisted after cessation of therapy (see WARNINGS and ADVERSE REACTIONS). Body as a Whole: allergic reactionsstrokestroke Endocrine/Metabolic: hypertriglyceridemia (see WARNINGS: Lipids)Suicidesuicide attemptssyncopesystemic hypersensitivity (see PRECAUTIONS: Hypersensitivity)tachycardiaTendonitisthrombocytopeniatransient pain in the chest (see PRECAUTIONS: Information for Patients)vascular thrombotic diseaseviolent behaviors (see WARNINGS: Psychiatric Disorders)weakness Psychiatric: suicidal ideationweight loss Cardiovascular: palpitation

Updated Date: Sep 27, 2018 EST

• September 27, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: Adverse Drug Reactions Reported in < 1% of Patients During Clinical Trials Digestive System: Gastritisagranulocytosis and pancytopenia. Nervous System: Depressionanorexiaanuriaaphthous ulcerations of the buccal mucosaaplastic anemiaazotemiabruisingcystitisdiplopia and optic neuritis. Skin and Appendages: Exfoliative dermatitisdisorientationdry mouth and blood in the stool. Increases in alkaline phosphatasedysuriaelectrocardiographic changes and supraventricular tachycardia. Genitourinary Tract: Renal failureflatulencegastrointestinal hemorrhagehematuriahemolytic anemiahemorrhageinsomniainterstitial nephritisjaundice and cholestatic hepatitisLDHlymphadenopathymalaisemastodynia and fever.metallic taste and pancreatitis (see PRECAUTIONS). Cardiovascular: Atrial fibrillationnephrosis and papillary necrosis (see WARNINGS). Hyper sensitivity: Angioedema (angioneurotic edema). Hematologic: Purpuraoliguriapeptic ulcer with/without perforationpersonality changepulmonary edemaseizures and trigeminal neuralgia. Special Senses: Burning tongueSGOTStevens-Johnson Syndrome and alopecia. Miscellaneous: AnaphylaxistachycardiathrombocytopeniaTOXIC EPIDERMAL NECROLYSISurticaria

Updated Date: Sep 27, 2018 EST

• September 25, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: abdominal painacneiform eruptionsaggravation/masking of infectionsallergic dermatitisAllergic Reactions anaphylactoid or hypersensitivity reactionsalopeciaamenorrheaanaphylaxisand occupational performance)angioedemaangioedema. Cardiovascular System bradycardiaangioneurotic edemaanorexia which may result in weight lossanxietyas in traumaaseptic necrosis of femoral and humeral headsatrophy and thinning of skinattentionbenign intracranial hypertensionbuffalo humpcardiac arrestcardiac arrhythmiascardiac enlargementcataracts (including posterior subcapsular cataracts)central serous chorioretinopathycirculatory collapseconcentrationcongestive heart failureconstipationcontact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.convulsionsdecreased carbohydrate and glucose tolerancedecreased resistance to infection (see WARNINGS: Infection)deliriumdementia (characterized by deficits in memory retentiondepressiondevelopment of cushingoid statediabetes mellitus (new onset or manifestations of latent)diarrheadizzinessdry scaly skinecchymoses and petechiae (bruising)ECG changes caused by potassium deficiencyedemaEEG abnormalitieselevation in serum liver enzyme levels (usually reversible upon discontinuation)emotional instability and irritabilityerythemaestablishment of secondary bacterialeuphoriaexophthalmosfacial edemafat embolismfluid retentionfungal and viral infectionsgastric irritationglaucomaglycosuriahallucinationsheadachehepatomegalyhiccupshirsutismhyperglycemiahypertension or aggravation of hypertensionhyperthyroidism (see WARNINGS: Endocrine)hypertrichosishypertrophic cardiomyopathy in premature infantshypokalemiahypokalemic alkalosishypotension or shock-like reactionhypothyroidismimmunosuppresionimpaired cognitionimpaired wound healingincidence of severe psychiatric symptomsincrease risk of fractureincreased appetite and weight gainincreased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatmentincreased intraocular pressure (see PRECAUTIONS: Ophthalmic)increased motor activityincreased or decreased motility and number of spermatozoaincreased requirements for insulin or oral hypoglycemic agents in diabeticsincreased sweatinginsomniaischemic neuropathyKarposi’s sarcoma (see PRECAUTIONS: General Precautions)life-threatening hypotensionlipids abnormallong-term memory lossloss of muscle masslupus erythematosus-like lesionsmalaisemaniamental speed and efficiencymetabolic alkalosismood swingsmoon facemuscle weaknessmyalgiasmyocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal)nauseanecrotizing angiitisnegative nitrogen balance caused by protein catabolismneuritisneuropathyneutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgiasoptic nerve damageoropharyngeal candidiasisosteopeniaosteoporosis (see PRECAUTIONS: Musculoskeletal)pancreatitispapilledema. Other abnormal fat depositsparesthesiapathologic fracture of long bonespeptic ulcer with possible perforation and hemorrhageperforation of the small and large intestine (particularly in patients with inflammatory bowel disease)perineal irritationpersonality changespostmenopausal bleeding or other menstrual irregularitiespotassium losspsychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditionspulmonary edemapurpurapyrexia. To report SUSPECTED ADVERSE EVENTSrashrestlessnessschizophreniasecondary adrenocortical and pituitary unresponsiveness (particularly in times of stresssevere tiredness or weakness)sodium retention with resulting edema. Gastrointestinal abdominal distentionsteroid myopathystriaesubcutaneous fat atrophysuppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patientssuppression of reactions to skin testssurgery or illness) (see WARNINGS: Endocrine)syncopetachycardiatelangiectasistendon rupture (particularly of the Achilles tendon)thin fragile skinthinning scalp hairthromboembolismthrombophlebitisulcerative esophagitisurticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgiasvasculitis. Dermatologic acneverbal memory lossvertebral compression fractures. Neurological/Psychiatric amnesiavertigovomiting. Hematologic anemiawithdrawn behavior. Ophthalmic blurred vision

Updated Date: Sep 25, 2018 EST

• September 25, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: about 16 in 100; constipation and sedationabout 33 in 100; dizzinessand dryness of eyes.Closeand tachycardia. Cases of sinus bradycardia and atrioventricular block have been reportedand urinary retention. Hematologic: Thrombocytopenia. Metabolic: Gynecomastiaand urticaria. Gastrointestinal: Abdominal painand vivid dreams or nightmares. Dermatological: Alopeciaand vomiting. Genitourinary: Decreased sexual activityand weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa. Ophthalmological: Accommodation disorderand withdrawal syndrome. Also reported were a weakly positive Coombs' test and increased sensitivity to alcohol. Cardiovascular: Bradycardiaangioneurotic edemaanorexiaanxietyblurred visionboth with and without the use of concomitant digitalis. Central Nervous System: Agitationburning of the eyesbut in many cases patients were receiving concomitant medication and a causal relationship has not been established. Body as a Whole: Fatiguecongestive heart failureconstipationdecreased lacrimationdeliriumdelusional perceptiondifficulty in micturitioneach about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochlorideelectrocardiographic abnormalities (i.e.erectile dysfunctionfeverhallucinations (including visual and auditory)headachehepatitishigh degree AV block and arrhythmias)hivesinsomniajunctional bradycardialoss of libidomalaisemental depressionmild transient abnormalities in liver function testsMost adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouthnauseanervousnessnocturiaoccurring in about 40 of 100 patients; drowsinessorthostatic symptomsother behavioral changespallorpalpitationsparesthesiaparotitisprurituspseudo-obstruction (including colonic pseudo-obstruction)rashRaynaud's phenomenonrestlessnesssalivary gland painsinus node arrestsleep disordersyncopetransient elevation of blood glucose or serum creatine phosphokinaseweakness

Updated Date: Sep 25, 2018 EST

• July 27, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: acute kidney failureacute renal failureallergic reactionamylase increasedand eye hemorrhage. Urogenital System Abnormal renal functionand procedural complication. Cardiovascular System Arrhythmiaand respiratory alkalosis. Musculoskeletal System Arthralgiaand rigors. Nervous System Agitationand sinusitis. Skin & Appendages Alopeciaand thrombocytopenia. Metabolic & Nutritional Disorders Acidosisand tremor. Respiratory System Asthmaand vaginal hemorrhage.and vasodilatation (flushing). Digestive System Anorexiaand veno-occlusive liver disease. Hemic & Lymphatic System Anemiaand vesiculobullous rash. Special Senses Conjunctivitisatelectasisatrial fibrillationbone painbradycardiacardiac arrestcardiomegalycell-mediated immunological reactioncellulitisclinical trials: Body as a Whole Abdomen enlargedcoagulation disordercomaconstipationconvulsioncoughdepressiondizzinessdry eyesdry mouth/nosedry skindysesthesiadyspepsiadysphagiaDystoniadysuriaecchymosiseructationface edemafecal incontinenceflatulencefluid overloadgraft-versus-host diseasegum/oral hemorrhagehallucinationshematemesishemoptysishemorrhageHemorrhoidshepatocellular damagehepatomegalyherpes simplexhiccuphyperchloremiahyperkalemiahypermagnesemiahyperphosphatemiahyperventilationhyponatremiahypophosphatemiahypoproteinemiaileusinfluenza-like symptomsinjection site inflammationKidney Failurelactate dehydrogenase increasedLess Common Adverse Events The following adverse events also have been reported in 2% to 10% of AmBisome-treated patients receiving chemotherapy or bone marrow transplantationliver function test abnormallung edemamaculopapular rashmalaisemucositismyalgianeck painnervousnessnonprotein nitrogen (NPN) increasedor who had HIV disease in six comparativeparesthesiapetechiapharyngitispneumoniapostural hypotensionprothrombin decreasedprothrombin increasedpurpurarectal disorderrespiratory failurerespiratory insufficiencyskin discolorationskin disorderskin ulcersomnolencestomatitisthinking abnormalitytoxic nephropathyulcerative stomatitisurinary incontinenceurticariavalvular heart diseasevascular disorder

Updated Date: Jul 27, 2018 EST

• July 25, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: allergic dermatitisanaphylactoid reactionanaphylaxisangioedema. Cardiovascular: Bradycardiaas in traumabowel/bladder dysfunctionbowel/bladder dysfunction (after intrathecal administration)calcinosis (following intra-articular or intra-lesional use)cardiac arrestcardiac arrhythmiascardiac enlargementCharcot-like arthropathycirculatory collapsecongestive heart failurecutaneous and subcutaneous atrophydecreased resistance to infectiondepressiondevelopment of cushingoid statedry scaly skinecchymoses and petechiaeedemaelevation in serum liver enzyme levels (usually reversible upon discontinuation)emotional instabilityerythemaeuphoriafat embolismfluid retentionglaucomaglycosuriaheadachehepatomegalyhiccupshirsutismhyperpigmentationhypertensionhypertrichosishypertrophic cardiomyopathy in premature infantshypokalemic alkalosishypopigmentationimpaired wound healingincreased appetiteincreased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatmentincreased intraocular pressureincreased or decreased motility and number of spermatozoaincreased requirements for insulin or oral hypoglycemic agents in diabetesincreased sweatinginfectioninjection site infections following non-sterile administration (see WARNINGS)insomnialoss of muscle massmalaisemanifestations of latent diabetes mellitusmeningitismenstrual irregularitiesmood swingsmoon facemuscle weaknessmyocardial rupture following recent myocardial infarction (see WARNINGS)nauseaneuritisneuropathyocular and periocular inflammation including allergic reactionsor illness)osteoporosispancreatitisparapareisis/paraplegiaparesthesiapathologic fracture of long bonespeptic ulcer with possible subsequent perforation and hemorrhageperforation of the small and large intestine (particularly in patients with inflammatory bowel disease)personality changesposterior subcapsular cataracts. Other: Abnormal fat depositspostinjection flare (following intra-articular use)potassium losspsychic disorderspulmonary edemarashresidue or slough at injection siterhinitissecondary adrenocortical and pituitary unresponsiveness (particularly in times of stressseizuressensory disturbances. Intranasal: Allergic reactionssodium retention. Gastrointestinal: Abdominal distentionsphenopalatine ganglion): blindness. Closesterile abscesssteroid myopathystriaesuppressed reactions to skin testssuppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patientssurgerysyncopetachycardiatemporary/permanent visual impairment including blindness. Miscellaneous injection sites (scalptemporary/permanent visual impairment including blindness. Ophthalmic: Increased intraocular pressuretendon ruptureThe following adverse reactions have been reported with DEPO-MEDROL or other corticosteroids: Allergic reactions: Allergic or hypersensitivity reactionsthin fragile skinthinning scalp hairthromboembolismthrombophlebitistonsillar faucesulcerative esophagitis. Metabolic: Negative nitrogen balance due to protein catabolism. Musculoskeletal: Aseptic necrosis of femoral and humeral headsurticaria. Endocrine: Decreased carbohydrate and glucose tolerancevasculitis. Dermatologic acnevertebral compression fractures. Neurologic/Psychiatric: Convulsionsvertigo. Ophthalmic: Exophthalmosesweight gain. The following adverse reactions have been reported with the following routes of administration: Intrathecal/Epidural: Arachnoiditis

Updated Date: Jul 25, 2018 EST

• July 20, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: (listed alphabeticallyabdominal painacneiform eruptionsaggravation/masking of infectionsallergic dermatitisalopeciaamenorrheaanaphylaxisand occupational performance)angioedemaangioedema. Cardiovascular System bradycardiaangioneurotic edemaanorexia which may result in weight lossanxietyas in traumaaseptic necrosis of femoral and humeral headsatrophy and thinning of skinattentionbenign intracranial hypertensionbuffalo humpcardiac arrestcardiac arrhythmiascardiac enlargementcataracts (including posterior subcapsular cataracts)central serous chorioretinopathycirculatory collapseconcentrationcongestive heart failureconstipationconvulsionsdecreased carbohydrate and glucose tolerancedecreased resistance to infection (see WARNINGS: Infection)deliriumdementia (characterized by deficits in memory retentiondepressiondevelopment of cushingoid statediabetes mellitus (new onset or manifestations of latent)diarrheadizzinessdry scaly skinecchymoses and petechiae (bruising)ECG changes caused by potassium deficiencyedemaEEG abnormalitieselevation in serum liver enzyme levels (usually reversible upon discontinuation)emotional instability and irritabilityerythemaestablishment of secondary bacterialeuphoriaexophthalmosfacial edemafat embolismfluid retentionfungal and viral infectionsgastric irritationglaucomaglycosuriahallucinationsheadachehepatomegalyhiccupshirsutismhyperglycemiahypertension or aggravation of hypertensionhyperthyroidism (see WARNINGS: Endocrine)hypertrichosishypertrophic cardiomyopathy in premature infantshypokalemiahypokalemic alkalosishypotension or shock-like reactionhypothyroidismimmunosuppressionimpaired cognitionimpaired wound healingincidence of severe psychiatric symptomsincrease risk of fractureincreased appetite and weight gainincreased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatmentincreased intraocular pressure (see PRECAUTIONS: Ophthalmic)increased motor activityincreased or decreased motility and number of spermatozoaincreased requirements for insulin or oral hypoglycemic agents in diabeticsincreased sweatinginsomniaischemic neuropathyKarposi’s sarcoma (see PRECAUTIONS: General Precautions)life-threatening hypotensionlipids abnormallong-term memory lossloss of muscle masslupus erythematosus-like lesionsmalaisemaniamental speed and efficiencymetabolic alkalosismood swingsmoon facemuscle weaknessmyalgiasmyocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal)nauseanecrotizing angiitisnegative nitrogen balance caused by protein catabolismneuritisneuropathyneutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgiasoptic nerve damageoropharyngeal candidiasisosteopeniaosteoporosis (see PRECAUTIONS: Musculoskeletal)pancreatitispapilledema. Other abnormal fat depositsparesthesiapathologic fracture of long bonespeptic ulcer with possible perforation and hemorrhageperforation of the small and large intestine (particularly in patients with inflammatory bowel disease)perineal irritationpersonality changespostmenopausal bleeding or other menstrual irregularitiespotassium losspsychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditionspulmonary edemapurpurapyrexia. Closerashrestlessnessschizophreniasecondary adrenocortical and pituitary unresponsiveness (particularly in times of stresssevere tiredness or weakness)sodium retention with resulting edema. Gastrointestinal abdominal distentionsteroid myopathystriaesubcutaneous fat atrophysuppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patientssuppression of reactions to skin testssurgery or illness) (see WARNINGS: Endocrine)syncopetachycardiatelangiectasistendon rupture (particularly of the Achilles tendon)The initial dosage of prednisone Tabletsthin fragile skinthinning scalp hairthromboembolismthrombophlebitisulcerative esophagitisunder each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactionsurticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgiasvasculitis. Dermatologic acneverbal memory lossvertebral compression fractures. Neurological/Psychiatric amnesiavertigovomiting. Hematologic anemiawithdrawn behavior. Ophthalmic blurred vision

Updated Date: Jul 20, 2018 EST

• July 18, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: acarodermatitisacneactive-controlledalanine aminotransferase increasedamenorrheaand anorgasmia Renal and Urinary Disorders: enuresisand Mediastinal Disorders: wheezingand open-label studies of RISPERDAL ® in adults and pediatric patients. Blood and Lymphatic System Disorders: anemiaanorexia Musculoskeletal and Connective Tissue Disorders: joint stiffnessaptyalism General Disorders: edema peripheralatrioventricular block Ear and Labyrinth Disorders: ear painatrioventricular block first degreeblood glucose increasedblood pressure decreasedblood prolactin increasedblunted affectbody temperature decreasedbreast enlargement Respiratorybronchitisbronchopneumoniabundle branch block leftbundle branch block rightcellulitiscerebral ischemiacerebrovascular accidentcerebrovascular disordercheilitischest discomfortchillsconfusional stateconjunctivitiscoordination abnormalcystitisdepressed level of consciousnessdiabetic comadiscomfortdisturbance in attentiondrug withdrawal syndromedry eyedysarthriadyskinesiadysphoniadysuriaear infectionedemaejaculation disorderelectrocardiogram abnormaleosinophil count increasederectile dysfunctioneye dischargeeye infectioneye rollingeye swellingeyelid edemaeyelid margin crustingface edemafecal incontinencefecalomafeeling abnormal Immune System Disorders: drug hypersensitivity Infections and Infestations: pneumoniaflushinggait disturbancegalactorrheagastritisgeneralized edemaglaucomagranulocytopeniaGynecomastiahead titubation Psychiatric Disorders: agitationhematocrit decreasedhemoglobin decreasedhyperkeratosishyperventilationhypoesthesiainfluenzainfluenza-like illnessjoint swellinglacrimation increasedlibido decreasedlip swellinglistlessnesslocalized infectionloss of consciousnessmalaisemenstrual disordermiddle insomniamovement disordermuscular weaknessmusculoskeletal chest painmyalgianasal edema Skin and Subcutaneous Tissue Disorders: erythemaneck painnervousnessneuroleptic malignant syndromeneutropenia Cardiac Disorders: sinus bradycardiaonychomycosisOther Adverse Reactions Observed During the Clinical Trial Evaluation of Risperidone The following additional adverse reactions occurred across all placebo-controlledotitis mediaotitis media chronic Investigations: body temperature increasedperipheral coldnesspharyngitisphotophobiapitting edemapneumonia aspirationpollakiuriapolydipsiaposture abnormalproductive coughprurituspulmonary congestionralesrash erythematousrash generalizedrash maculopapularrash papularrespiratory disorderrespiratory tract congestionrespiratory tract infectionretrograde ejaculationrhabdomyolysis Nervous System Disorders: balance disorderseborrheic dermatitis Vascular Disorders: hypotensionsexual dysfunctionsinus congestionsinus tachycardiaskin discolorationskin disorderskin lesionsleep disordersluggishnessspeech disordersyncopetardive dyskinesiathirstThoracictinnitus Endocrine Disorders: hyperprolactinemia Eye Disorders: ocular hyperemiatonsillitistracheobronchitistransaminases increased Metabolism and Nutrition Disorders: decreased appetitetransient ischemic attackunresponsive to stimuliurinary incontinence Reproductive System and Breast Disorders: menstruation irregularvaginal dischargeviral infectionvisual acuity reduced Gastrointestinal Disorders: dysphagiawhite blood cell count decreased

Updated Date: Jul 18, 2018 EST

• July 17, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: acute renal failure in patients with pre-existing significantly impaired renal function Other adverse reactionsanaphylactoid reactionsanemiaaplastic anemiaappetite changes Cardiovascular system - arrhythmiaaseptic meningitis Respiratory - apneaastheniabloatingcerebrovascular accidentcomaconfusionconjunctivitisconstipationcontact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.Closedecreased creatinine clearancedepressiondiarrheadizzinessdream abnormalitiesdrowsinessdry eyesduodenititsdyspepsiadyspnea Skin and appendages - alopeciadysuriaedemaelevated liver enzymesemotional lability hallucinationseosinophiliaepigastric painerythema multiformeesophagitisexfoliative dermatitisflatulencefluid retentiongastric or duodenal ulcer with bleeding and/or perforationgastritisgastrointestinal bleedinggastrointestinal experiences (including abdominal paingingival ulcerglomerulitisglossitisheadacheshearing impairment Urogenital - azotemiaheartburnhematemesishematuriahemolytic anemiahepatitishepatorenal syndromehypertensionhypotensionIn patients taking ibuprofen or other NSAIDsincreased bleeding timeinfectioninsomniainterstitial nephritisjaundiceleukopenialiver failureliver necrosislymphadenopathymalaisemelenamyocardial infarctionnauseanervousnessneutropeniaoliguria/polyuriapalpitationspancreatitis Hemic and lymphatic system - agranulocystosispancytopenia Metabolic and nutritional - hyperglycemia Nervous system - convulsionsparesthesiaphotosensitivitypneumoniaproteinuriaprurituspurpurarashes (including maculopapular) and tinnitus. Additional adverse experiences reported occasionally include: Body as a whole - feverrectal bleeding Hemic and lymphatic system - ecchymosisrenal papillary necrosisrespiratory depressionrhinitis Skin and appendages - angioedemascotomata and/or changes in color vision)sepsis Cardiovascular system - congestive heart failure in patients with marginal cardiac functionsomnolenceStevens-Johnson syndromestomatitissweat Special senses - blurred vision Urogenital system - cystitissyncope Digestive system - dry mouthtachycardiathe most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: Abnormal renal functionthrombocytopenia Metabolic and nutritional - weight changes Nervous system - anxietytoxic epidermal necrosistremorstubular necrosis To report SUSPECTED ADVERSE EVENTSurticariavasculitis Digestive system - eructationvertigo Respiratory system - asthmavesiculobullous eruptions Special senses - amblyopia (blurred and/or diminished visionvomitingwhich occur rarely are: Body as a whole - anaphylactic reactions

Updated Date: Jul 17, 2018 EST

• July 16, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: (BUN)a causal relationship with carbidopa and levodopa has not been established. Respiratory: dyspneaactivation of latent Horner's syndromeagitationalopeciaand blood in the urine. Other adverse reactions that have been reported with levodopa alone and with various carbidopa levodopa formulationsand may occur with this combination product are: Body As A Whole: abdominal pain and distressand nausea. The following other adverse reactions have been reported with carbidopa and levodopa: Body As A Whole: chest painand other involuntary movementsand paranoid ideationanorexiaanxietyasthenia. Cardiovascular: cardiac irregularitiesbacteriabilirubinblepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time)blurred visionbradykinetic episodes ("on-off" phenomenon)bruxismbullous lesions (including pemphigus-like reactions). Musculoskeletal: back painburning sensation of the tongueconfusionconstipationCoombs test; elevated serum glucose; white blood cellscough. Skin: malignant melanoma (see also CONTRAINDICATIONS)dark sweat. Urogenital: urinary tract infectiondark urine. Laboratory Tests: decreased hemoglobin and hematocrit; abnormalities in alkaline phosphatasedecreased mental acuitydementiadepression with or without development of suicidal tendenciesdevelopment of duodenal ulcerdiarrheadilated pupils. Urogenital: urinary retentiondiplopiadisorientationdizzinessdream abnormalities including nightmaresdry mouthdyspepsiadysphagiadystoniceuphoriaextrapyramidal disorderfaintnessfallingfatigue. Cardiovascular: myocardial infarction. Gastrointestinal: gastrointestinal painflatulenceflushing. Special Senses: oculogyric crisesgait abnormalitiesgastrointestinal bleedinghallucinationsheadacheheartburnhemolytic and non-hemolytic anemiaHenoch-Schönlein purpurahiccups. Metabolic: edemahoarsenesshot flasheshypertensionhypotensionimpulse control symptoms. Convulsions also have occurred; howeverincreased libido including hypersexualityincreased sweatingincreased tremorinsomniaLDHleukopenia. Hypersensitivity: angioedemamalaisememory impairmentmuscle cramps. Nervous System/Psychiatric: psychotic episodes including delusionsmuscle twitchingnervousnessnumbnessorthostatic effects including orthostatic hypotensionpalpitation. Gastrointestinal: dark salivaparesthesiapathological gamblingperipheral neuropathy. Respiratory: pharyngeal painphlebitispriapism. Miscellaneous: bizarre breathing patternspruritussense of stimulation. Laboratory Tests: decreased white blood cell count and serum potassium; increased serum creatinine and uric acid; protein and glucose in urine.CloseSGOT (AST)SGPT (ALT)shoulder painsialorrheasomnolencesuch as choreiformsyncopetaste alterations. Hematologic: agranulocytosisThe most common adverse reactions reported with carbidopa and levodopa have included dyskinesiasthrombocytopeniatrismusupper respiratory infection. Skin: rashurinary frequencyurinary incontinenceurticariavomitingweight gainweight loss. Musculoskeletal: leg pain. Nervous System/Psychiatric: ataxia

Updated Date: Jul 16, 2018 EST

• July 13, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: Adverse Drug Reactions Reported in <1% of Patients During Clinical Trials Digestive System—GastritisAGRANULOCYTOSISand alopecia. Miscellaneous—Anaphylaxisand fever.and optic neuritis. Skin and Appendages—Exfoliative dermatitisand pancreatitis (see PRECAUTIONS). Cardiovascular—Atrial fibrillationand pancytopenia. Nervous System—Depressionand papillary necrosis (see WARNINGS). Hypersensitivity—Angioedema (angioneurotic edema). Hematologic—Purpuraand supraventricular tachycardia. Genitourinary Tract—Renal failureand trigeminal neuralgia. Special Senses—Burning tongueanorexiaanuriaaphthous ulcerations of the buccal mucosaaplastic anemiaazotemiablood in the stool. Increases in alkaline phosphatasebruisingcholestatic hepatitiscystitisdiplopiadisorientationdry mouthdysuriaelectrocardiographic changesflatulencegastro- intestinal hemorrhagehematuriahemolytic anemiahemorrhageinsomniainterstitial nephritisjaundiceLDHlymphadenopathymalaisemastodyniametallic tastenephrosisoliguriapeptic ulcer with/without perforationpersonality changepulmonary edemaseizuresSGOTStevens-Johnson syndrometachycardiathrombocytopeniaTOXIC EPIDERMAL NECROLYSISurticaria

Updated Date: Jul 13, 2018 EST

• July 12, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: abdominal painacneiform eruptionsaggravation/masking of infectionsallergic dermatitisAllergic Reactions anaphylactoid or hypersensitivity reactionsalopeciaamenorrheaanaphylaxisand occupational performance)angioedemaangioedema. Cardiovascular System bradycardiaangioneurotic edemaanorexia which may result in weight lossanxietyas in traumaaseptic necrosis of femoral and humeral headsatrophy and thinning of skinattentionbenign intracranial hypertensionbuffalo humpcardiac arrestcardiac arrhythmiascardiac enlargementcataracts (including posterior subcapsular cataracts)central serous chorioretinopathycirculatory collapseconcentrationcongestive heart failureconstipationcontact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.convulsionsdecreased carbohydrate and glucose tolerancedecreased resistance to infection (see WARNINGS: Infection)deliriumdementia (characterized by deficits in memory retentiondepressiondevelopment of cushingoid statediabetes mellitus (new onset or manifestations of latent)diarrheadizzinessdry scaly skinecchymoses and petechiae (bruising)ECG changes caused by potassium deficiencyedemaEEG abnormalitieselevation in serum liver enzyme levels (usually reversible upon discontinuation)emotional instability and irritabilityerythemaestablishment of secondary bacterialeuphoriaexophthalmosfacial edemafat embolismfluid retentionfungal and viral infectionsgastric irritationglaucomaglycosuriahallucinationsheadachehepatomegalyhiccupshirsutismhyperglycemiahypertension or aggravation of hypertensionhyperthyroidism (see WARNINGS: Endocrine)hypertrichosishypertrophic cardiomyopathy in premature infantshypokalemiahypokalemic alkalosishypotension or shock-like reactionhypothyroidismimmunosuppresionimpaired cognitionimpaired wound healingincidence of severe psychiatric symptomsincrease risk of fractureincreased appetite and weight gainincreased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatmentincreased intraocular pressure (see PRECAUTIONS: Ophthalmic)increased motor activityincreased or decreased motility and number of spermatozoaincreased requirements for insulin or oral hypoglycemic agents in diabeticsincreased sweatinginsomniaischemic neuropathyKarposi’s sarcoma (see PRECAUTIONS: General Precautions)life-threatening hypotensionlipids abnormallong-term memory lossloss of muscle masslupus erythematosus-like lesionsmalaisemaniamental speed and efficiencymetabolic alkalosismood swingsmoon facemuscle weaknessmyalgiasmyocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal)nauseanecrotizing angiitisnegative nitrogen balance caused by protein catabolismneuritisneuropathyneutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgiasoptic nerve damageoropharyngeal candidiasisosteopeniaosteoporosis (see PRECAUTIONS: Musculoskeletal)pancreatitispapilledema. Other abnormal fat depositsparesthesiapathologic fracture of long bonespeptic ulcer with possible perforation and hemorrhageperforation of the small and large intestine (particularly in patients with inflammatory bowel disease)perineal irritationpersonality changespostmenopausal bleeding or other menstrual irregularitiespotassium losspsychiatric disorders including steroid psychoses or aggravation of pre-existing psychiatric conditionspulmonary edemapurpurapyrexia. To report SUSPECTED ADVERSE EVENTSrashrestlessnessschizophreniasecondary adrenocortical and pituitary unresponsiveness (particularly in times of stresssevere tiredness or weakness)sodium retention with resulting edema. Gastrointestinal abdominal distentionsteroid myopathystriaesubcutaneous fat atrophysuppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patientssuppression of reactions to skin testssurgery or illness) (see WARNINGS: Endocrine)syncopetachycardiatelangiectasistendon rupture (particularly of the Achilles tendon)thin fragile skinthinning scalp hairthromboembolismthrombophlebitisulcerative esophagitisurticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgiasvasculitis. Dermatologic acneverbal memory lossvertebral compression fractures. Neurological/Psychiatric amnesiavertigovomiting. Hematologic anemiawithdrawn behavior. Ophthalmic blurred vision

Updated Date: Jul 12, 2018 EST

• July 11, 2018
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  • Pharma / Biotech
• Tags: about 16 in 100; constipation and sedationabout 33 in 100; dizzinessand dryness of eyes.Closeand tachycardia. Cases of sinus bradycardia and atrioventricular block have been reportedand urinary retention. Hematologic: Thrombocytopenia. Metabolic: Gynecomastiaand urticaria. Gastrointestinal: Abdominal painand vivid dreams or nightmares. Dermatological: Alopeciaand vomiting. Genitourinary: Decreased sexual activityand weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa. Ophthalmological: Accommodation disorderand withdrawal syndrome. Also reported were a weakly positive Coombs' test and increased sensitivity to alcohol. Cardiovascular: Bradycardiaangioneurotic edemaanorexiaanxietyblurred visionboth with and without the use of concomitant digitalis. Central Nervous System: Agitationburning of the eyesbut in many cases patients were receiving concomitant medication and a causal relationship has not been established. Body as a Whole: Fatiguecongestive heart failureconstipationdecreased lacrimationdeliriumdelusional perceptiondifficulty in micturitioneach about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tabletselectrocardiographic abnormalities (i.e.erectile dysfunctionfeverhallucinations (including visual and auditory)headachehepatitishigh degree AV block and arrhythmias)hivesinsomniajunctional bradycardialoss of libidomalaisemental depressionmild transient abnormalities in liver function testsMost adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouthnauseanervousnessnocturiaoccurring in about 40 of 100 patients; drowsinessorthostatic symptomsother behavioral changespallorpalpitationsparesthesiaparotitisprurituspseudo-obstruction (including colonic pseudo-obstruction)rashRaynaud's phenomenonrestlessnesssalivary gland painsinus node arrestsleep disordersyncopetransient elevation of blood glucose or serum creatine phosphokinaseweakness

Updated Date: Jul 11, 2018 EST

• July 11, 2018
• 0
• Category:
  • Pharma / Biotech
• Tags: 000 Units Adult: Over 2 million Units Chronic toxicity (4000 Units daily for longer than 18 months; 500000 Units daily for two months. Hypervitaminosis A Syndrome: 1. General manifestations: Fatigue000 Units/kg body weight for 6 to 15 months) Infants 3 to 6 months old: 18000 Units/kg body weight) Infant: 350200 Units/100 mL. The treatment of hypervitaminosis A consists of immediate withdrawal of the vitamin along with symptomatic and supportive treatment.Close500 Units (water dispersed)/day for 1 to 3 months. Adult: 1 million Units daily for three days; 50abdominal discomfortalopeciaand duration of administration. Acute toxicity — single dose (25and exophthalmos. c. Dermatologic: fissures of the lipsand increased intracranial pressure as manifested by bulging fontanelsand increased pigmentation. d. Systemic: hypomenorrheaand premature closure of the epiphysis leading to arrested bone growth in children. b. Central Nervous System: irritabilityand vomiting. 2. Specific manifestations: a. Skeletal: hepatotoxicityanorexiadosagedrying and cracking of the skinhard tender cortical thickening over the radius and tibiaheadachehepatosplenomegalyhepatotoxicityjaundicelethargyleukopeniamalaisemassive desquamationmigratory arthralgiapapilledemascalingsizeslow growthThe following amounts have been found to be toxic orally. Toxicity manifestations depend on the agevitamin A plasma level over 1

Updated Date: Jul 11, 2018 EST