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Rocaltrol (Calcitriol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rocaltrol (Calcitriol) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (45)
Life Threatening Events (5)
Disability (3)

Reports by Reaction Type

Hypercalcaemia (22)Decreased Appetite (6)Drug Interaction (5)Cardiac Failure (5)Nausea (4)Hypereosinophilic Syndrome (4)Renal Failure (4)Renal Impairment (4)Productive Cough (3)Pain (3)Malaise (3)Blood Creatinine Increased (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Rocaltrol (Calcitriol). For a complete list or a specific selection of reports, please use the links above.

Possible Rocaltrol side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-26

Patient: female

Reactions: Malaise, Toxicity To Various Agents, Hypercalcaemia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cacit Vitamine D3 (Cacit Vitamine D3-Calcium Carbonate, Cholecalcifero
    Dosage: 1 df, qd, oral
    Administration route: Oral
    Indication: Hypoparathyroidism
    Start date: 2012-05-01
    End date: 2012-06-22

Rocaltrol
    Dosage: 2 df qd, oral
    Administration route: Oral
    Indication: Hypoparathyroidism
    Start date: 2012-05-01
    End date: 2012-06-22

Natecal (Natecal-Calcium Carbonate)
    Dosage: 1 df qd, oral
    Administration route: Oral
    Indication: Hypoparathyroidism
    Start date: 2012-05-01
    End date: 2012-06-22

Other drugs received by patient: Pamidronate Disodiuim; Furosemide; Lanoxin; Tiotropium Bromide; Rifaximin; Metformin Hydrochloride; Levothyroxine Sodium; Coumadin; Atorvastatin; Omeprazole; Allopurinol



Possible Rocaltrol side effects in 70 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-20

Patient: 70 year old male

Reactions: Renal Disorder, Vomiting, Blood Urea Increased, Blood Creatinine Increased, Hypercalcaemia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rocaltrol
    Dosage: (2 ug qd oral)
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2011-09-01
    End date: 2011-01-01

Calcium Lactate (Calcium Lactate)
    Dosage: (6 g qd oral)
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2011-09-01
    End date: 2011-01-01



Possible Rocaltrol side effects in 60 year old female

Reported by a pharmacist from Japan on 2012-07-18

Patient: 60 year old female

Reactions: Jaundice, Bile Duct Stone

Drug(s) suspected as cause:
Rocaltrol



Possible Rocaltrol side effects in female

Reported by a physician from Japan on 2012-07-16

Patient: female

Reactions: Platelet Count Decreased

Drug(s) suspected as cause:
Pegasys
    Dosage: 135 ug 1x/week subcutaneous
    Indication: Hepatitis C
    Start date: 2011-04-15
    End date: 2012-02-03

Rocaltrol
    Dosage: 0.25 ug bid oral
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-04-15
    End date: 2012-02-09

Copegus
    Dosage: 300 mg bid oral
    Administration route: Oral
    Start date: 2011-04-15
    End date: 2012-02-09



Possible Rocaltrol side effects in 77 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-13

Patient: 77 year old male

Reactions: Nausea, Eosinophilic Myocarditis, Pleural Effusion, Eosinophil Count Increased, Cardiac Failure Acute, Hypercalcaemia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcium Carbonate
    Dosage: df oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-06-01

Rocaltrol
    Dosage: df oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-06-01



Possible Rocaltrol side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-07-12

Patient: 63 year old female

Reactions: Drug Interaction, Hypercalcaemia, Renal Failure Acute

Drug(s) suspected as cause:
Rocaltrol
    Dosage: 0.25 ?g tid oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-17
    End date: 2012-04-16

Calcium-Sandoz / 00751528 / (Calcium -Sandoz-Calcium Glubionate (Not Spec
    Dosage: 3 df qd oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-17
    End date: 2012-04-06



Possible Rocaltrol side effects in 32 year old female

Reported by a physician from Spain on 2012-07-10

Patient: 32 year old female

Reactions: Drug Interaction, Angiolipoma, Hypercalcaemia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Losartan Potassium
    Dosage: 12.5 mg qd, oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01
    End date: 2012-03-01

Ideos Unidia (Ideos Unidia (Calcium Carbonate, Cholecalciferol)) (Not
    Dosage: 1 df qd oral
    Administration route: Oral
    Indication: Renal Failure Chronic
    Start date: 2012-01-01
    End date: 2012-03-01

Rocaltrol
    Dosage: 1 ug qd oral
    Administration route: Oral
    Indication: Renal Failure Chronic
    Start date: 2011-10-01
    End date: 2012-03-01

Other drugs received by patient: Calcium; Vitamin D



Possible Rocaltrol side effects in 60 year old female

Reported by a pharmacist from Japan on 2012-07-05

Patient: 60 year old female

Reactions: Jaundice, Bile Duct Stone

Drug(s) suspected as cause:
Rocaltrol



Possible Rocaltrol side effects in 87 year old male

Reported by a pharmacist from Japan on 2012-07-03

Patient: 87 year old male

Reactions: Lung Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Soleton
    Dosage: unk
    Administration route: Oral

Doxazosin Mesylate
    Dosage: unk
    Administration route: Oral

Mucosta
    Dosage: unk
    Administration route: Oral

Adalat
    Dosage: unk
    Administration route: Oral

Lasix
    Dosage: unk
    Administration route: Oral

Tenormin
    Dosage: 25 mg, unk
    Administration route: Oral

Rocaltrol
    Dosage: unk
    Administration route: Oral

Spelear
    Dosage: unk
    Administration route: Oral

Aldactone
    Dosage: unk
    Administration route: Oral



Possible Rocaltrol side effects in 73 year old female

Reported by a pharmacist from Spain on 2012-06-29

Patient: 73 year old female

Reactions: Hypercalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rocaltrol



Possible Rocaltrol side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-13

Patient: 67 year old female

Reactions: Renal Impairment, Malaise, Nausea, Gait Disturbance, Hypercalcaemia, Calculus Bladder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rocaltrol
    Dosage: (df oral), (reduced dose oral)
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2010-08-01

Rocaltrol
    Dosage: (df oral), (reduced dose oral)
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2005-01-01
    End date: 2010-08-01

Other drugs received by patient: Calcium Preparations



Possible Rocaltrol side effects in female

Reported by a physician from Japan on 2012-06-12

Patient: female, weighing 40.0 kg (88.0 pounds)

Reactions: Productive Cough, Weight Decreased, Hypereosinophilic Syndrome, Cardiac Failure, Hypophagia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Rocaltrol

Other drugs received by patient: Nizatidine; Carnaculin; Norvasc; Risumic; Celebrex; Levothyroxine Sodium; Clivarine; Nespo; Shakuyakukanzoto; Calcium Carbonate; Fosrenol; Heparin; Ebastine; Nitrazepam; Celectol; Nasonex; Pemirolast Potassium; Olmetec



Possible Rocaltrol side effects in female

Reported by a physician from Japan on 2012-06-06

Patient: female, weighing 40.0 kg (88.0 pounds)

Reactions: Aphagia, Productive Cough, Hypereosinophilic Syndrome, Cardiac Failure, White Blood Cell Count Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Rocaltrol

Other drugs received by patient: Carnaculin; Celectol; Clivarine; Levothyroxine Sodium; Olmesartan Medoxomil; Norvasc; Shakuyakukanzoto; Nasonex; Celebrex; Nespo; Calcium Carbonate; Ebastine; Risumic; Nitrazepam; Forsenol; Pemirolast Potassium; Nizatidine; Heparin



Possible Rocaltrol side effects in 87 year old male

Reported by a pharmacist from Japan on 2012-06-04

Patient: 87 year old male

Reactions: Lung Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Tenormin
    Administration route: Oral

Adalat
    Administration route: Oral

Aldactone
    Administration route: Oral

Lasix
    Administration route: Oral

Doxazosin Mesylate
    Administration route: Oral

Spelear
    Administration route: Oral

Mucosta
    Administration route: Oral

Rocaltrol
    Administration route: Oral

Soleton
    Administration route: Oral



Possible Rocaltrol side effects in female

Reported by a physician from Japan on 2012-06-01

Patient: female, weighing 40.0 kg (88.0 pounds)

Reactions: Asthma, Productive Cough, Weight Decreased, Aphagia, Hypereosinophilic Syndrome, Rales, Cardiac Failure, RED Blood Cell Count Decreased, White Blood Cell Count Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Rocaltrol

Other drugs received by patient: Olmesartan Medoxomil; Fosrenol; Carnaculin; Celectol; Norvasc; Calcium Carbonate; Nizatidine; Nasonex; Heparin; Nespo; Shakuyakukanzoto; Levothyroxine Sodium; Risumic; Pemirolast Potassium; Celebrex; Nitrazepam; Clivarine; Ebastine



Possible Rocaltrol side effects in 66 year old female

Reported by a consumer/non-health professional from China on 2012-05-09

Patient: 66 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Breast Pain, Heart Rate Decreased, Cerebral Infarction, Swelling, Therapeutic Response Unexpected

Drug(s) suspected as cause:
Rocaltrol
    Dosage: 0.25 ug, qd, oral
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2012-02-01

Blood-Activating Traditional Chinese Medicine
    Dosage: df
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Other drugs received by patient: Evista; Lipitor



Possible Rocaltrol side effects in female

Reported by a physician from Japan on 2012-05-02

Patient: female, weighing 40.0 kg (88.0 pounds)

Reactions: Aphagia, Basophil Count Increased, Cardiac Failure, Hypereosinophilic Syndrome, Unevaluable Event

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Rocaltrol

Other drugs received by patient: Nizatidine; Carnaculin / 00088101 /; Nasonex; Levothyroxine Sodium; Fosrenol; Heparin; Olmesartan Medoxomil; Celectol; Nespo; Norvasc; Shakuyakukanzoto; Celebrex; Clivarine; Calcium Carbonate; Risumic; Pemirolast Potassium; Eastel; Benzalin / 00036201 /



Possible Rocaltrol side effects in female

Reported by a physician from Italy on 2012-04-26

Patient: female

Reactions: Renal Failure, Oliguria, Hypercalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rocaltrol
    Dosage: (1 df qd oral)
    Administration route: Oral
    Indication: Hypocalcaemia
    Start date: 2012-02-03
    End date: 2012-02-03

Irbesartan
    Dosage: (1 df qd oral)
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-02-03
    End date: 2012-02-03

Irbesartan
    Dosage: (1 df qd oral)
    Administration route: Oral
    Indication: Hypocalcaemia
    Start date: 2012-02-03
    End date: 2012-02-03

Other drugs received by patient: Antra / 00661201 /; Norvasc; Ticlid; Lasix; Aranesp



Possible Rocaltrol side effects in 94 year old female

Reported by a physician from Italy on 2012-04-26

Patient: 94 year old female

Reactions: Renal Failure, Oliguria, Hypercalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Irbesartan
    Dosage: 1 df= 1 dosage unit/die reduced to 1/2 dosage unit
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-04-03
    End date: 2012-04-03

Rocaltrol
    Dosage: 1 df= 1 dosage unit / die
    Administration route: Oral
    Indication: Hypocalcaemia
    Start date: 2012-02-03
    End date: 2012-04-03

Other drugs received by patient: Norvasc; Lasix; Ticlid; Aranesp; Omeprazole



Possible Rocaltrol side effects in female

Reported by a physician from Japan on 2012-04-26

Patient: female

Reactions: Cardiac Failure, Eosinophil Count Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Rocaltrol



Possible Rocaltrol side effects in female

Reported by a physician from Italy on 2012-04-19

Patient: female

Reactions: Renal Failure, Hypercalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Irbesartan
    Dosage: (1 df qd oral)
    Administration route: Oral
    Indication: Hypocalcaemia
    Start date: 2012-02-03
    End date: 2012-02-03

Irbesartan
    Dosage: (1 df qd oral)
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-02-03
    End date: 2012-02-03

Rocaltrol
    Dosage: (1 df qd oral)
    Administration route: Oral
    Indication: Hypocalcaemia
    Start date: 2012-02-03
    End date: 2012-02-03

Other drugs received by patient: Omeprazole; Lasix; Aranesp; Norvasc; Ticlid



Possible Rocaltrol side effects in 94 year old female

Reported by a consumer/non-health professional from Italy on 2012-04-16

Patient: 94 year old female

Reactions: Renal Failure, Oliguria, Hypercalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Irbesartan
    Dosage: 1 df= 1 dosage unit/die reduced to 1/2 dosage unit
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-04-03
    End date: 2012-04-03

Rocaltrol
    Dosage: 1 df= 1 dosage unit / die
    Administration route: Oral
    Indication: Hypocalcaemia
    Start date: 2012-02-03
    End date: 2012-04-03

Other drugs received by patient: Norvasc; Omeprazole; Ticlid; Lasix; Aranesp



Possible Rocaltrol side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-06

Patient: 83 year old female, weighing 40.0 kg (88.0 pounds)

Reactions: Respiratory Disorder, Nausea, Hypercalcaemia, Weight Increased, Aortic Valve Stenosis, Pleural Effusion, Cardiac Failure Congestive, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rocaltrol

Other drugs received by patient: Hanp; Albumin (Human)



Possible Rocaltrol side effects in female

Reported by a consumer/non-health professional from Germany on 2012-04-06

Patient: female

Reactions: Rash, Altered State of Consciousness

Drug(s) suspected as cause:
Rocaltrol

Other drugs received by patient: ACE Inhibitors



Possible Rocaltrol side effects in 63 year old female

Reported by a physician from Spain on 2012-04-05

Patient: 63 year old female

Reactions: Drug Interaction, Hypercalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcium Carbonate
    Dosage: 500 mg tid oral
    Administration route: Oral
    Indication: Hypoparathyroidism
    Start date: 2009-03-01

Rocaltrol
    Dosage: df oral
    Administration route: Oral
    Indication: Hypoparathyroidism
    Start date: 2009-03-01
    End date: 2012-02-16

Other drugs received by patient: Zocor; Amiloride HCL and Hydrochlorothiazide



Possible Rocaltrol side effects in female

Reported by a individual with unspecified qualification from China on 2012-03-30

Patient: female

Reactions: Blood Calcium Decreased

Drug(s) suspected as cause:
Rocaltrol
    Dosage: (0.25 ug qd oral), (0.25 ug bid oral)
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2011-01-01
    End date: 2011-01-01

Rocaltrol
    Dosage: (0.25 ug qd oral), (0.25 ug bid oral)
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2012-02-01



Possible Rocaltrol side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-28

Patient: 77 year old female

Reactions: Renal Disorder, Metabolic Alkalosis, Disorientation, Milk-Alkali Syndrome, Hypertension, Hypercalcaemia, Blood Creatinine Increased, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcium (Calcium-Calcium Nos)
    Dosage: df
    Indication: Osteoporosis

Rocaltrol
    Dosage: df oral
    Administration route: Oral
    Indication: Osteoporosis

Diuretics (Diuresis (Unk Ingredients)-Diuretic Nos)
    Dosage: df oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-03-01



Possible Rocaltrol side effects in 75 year old female

Reported by a consumer/non-health professional from China on 2012-03-26

Patient: 75 year old female

Reactions: Drug Ineffective, Pain, Condition Aggravated, Pubic Pain, Muscle Spasms

Drug(s) suspected as cause:
Fosamax
    Dosage: (1 df 1x/week oral)
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2007-01-01

Rocaltrol
    Dosage: (0.25 ug qd oral) ; (0.5 ug qd oral)
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2007-01-01
    End date: 2012-01-01

Rocaltrol
    Dosage: (0.25 ug qd oral) ; (0.5 ug qd oral)
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2012-01-01



Possible Rocaltrol side effects in 75 year old female

Reported by a consumer/non-health professional from China on 2012-03-21

Patient: 75 year old female

Reactions: Drug Ineffective, Pain, Pubic Pain, Muscle Spasms

Drug(s) suspected as cause:
Rocaltrol
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2007-01-01
    End date: 2012-01-01

Rocaltrol
    Administration route: Oral
    Start date: 2012-01-01

Fosamax
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2007-01-01



Possible Rocaltrol side effects in 87 year old male

Reported by a pharmacist from Japan on 2012-03-16

Patient: 87 year old male

Reactions: Lung Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Doxazosin Mesylate
    Administration route: Oral

Lasix
    Administration route: Oral

Mucosta
    Administration route: Oral

Adalat
    Administration route: Oral

Spelear
    Administration route: Oral

Aldactone
    Administration route: Oral

Soleton
    Administration route: Oral

Rocaltrol
    Administration route: Oral

Tenormin
    Administration route: Oral

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