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Calcitriol (Calcitriol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to 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 (43)
Life Threatening Events (6)

Reports by Reaction Type

Hypercalcaemia (16)Confusional State (6)Dizziness (6)Coma (5)Blood Potassium Decreased (5)Nephrocalcinosis (5)Diabetes Mellitus (4)Thyroid Cancer (4)Syncope (4)Nausea (3)Convulsion (3)Haemolytic Anaemia (3)

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

Possible Calcitriol side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-15

Patient: female

Reactions: Gastrointestinal Haemorrhage, Hyperphosphataemia, Nausea, Anaemia, Gastroenteritis Radiation, Haemorrhagic Anaemia, Hypercalcaemia, Cholelithiasis, Iron Deficiency Anaemia, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcium Carbonate
    Dosage: 3000 mg, 1x/day:qd
    Administration route: Oral
    Start date: 2011-06-01
    End date: 2011-06-03

Calcium Carbonate
    Dosage: 1500 mg, unknown
    Administration route: Oral
    Start date: 2011-08-04
    End date: 2011-12-07

Calcitriol
    Dosage: 1.5 ug, 1x/day:qd
    Administration route: Oral
    Start date: 2009-12-30
    End date: 2010-05-13

Lanthanum Carbonate
    Dosage: 750 mg, 1x/day:qd
    Administration route: Oral
    Indication: Hyperphosphataemia
    Start date: 2009-12-03

Calcitriol
    Dosage: 1.0 ?g, unknown
    Administration route: Oral
    Start date: 2012-04-05

Calcium Carbonate
    Dosage: 1500 mg, 1x/day:qd
    Administration route: Oral
    Indication: Hyperphosphataemia
    Start date: 2009-12-03
    End date: 2010-05-13

Calcium Carbonate
    Dosage: 1500 mg, 1x/day:qd
    Administration route: Oral
    Start date: 2010-06-02
    End date: 2011-05-31

Calcitriol
    Dosage: .75 ug, 1x/day:qd
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-12-02

Lanthanum Carbonate
    Dosage: 1500 mg, 1x/day:qd
    Administration route: Oral
    Start date: 2009-11-12
    End date: 2009-12-02

Calcium Carbonate
    Dosage: 3000 mg, unknown
    Administration route: Oral
    Start date: 2011-12-08

Lanthanum Carbonate
    Dosage: 750 mg, 1x/day:qd
    Administration route: Oral
    Start date: 2009-06-16
    End date: 2009-11-11

Other drugs received by patient: Allopurinol; Calfina; Fulstan; Simvastatin; Isosorbide Mononitrate; Fulstan; Rocaltrol; Diovan; Amlodipine; Fulstan; Aspirin; Ersibon; Ersibon; Rocaltrol; Cefazolin Sodium; Omeprazole; Fulstan; Rebamipide; Bisoprolol Fumarate; Amoban; Fulstan; Fulstan



Possible Calcitriol side effects in 94 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-01

Patient: 94 year old male

Reactions: Confusional State, Blood 1,25-Dihydroxycholecalciferol Increased, Creatinine Renal Clearance Decreased, Diarrhoea, Dehydration, General Physical Health Deterioration, Calcium Phosphate Product Increased, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcitriol
    Dosage: 1 df daily oral
    Administration route: Oral
    End date: 2012-05-16

Stalevo 50
    Dosage: 2 dosage forms (1 dosage form,2 in 1 d) oral
    Administration route: Oral
    Indication: Parkinson's Disease
    End date: 2012-05-16

Other drugs received by patient: Levothyroxine Sodium; Betahistine Chloride; Previscan; Potassium Chloride



Possible Calcitriol side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: female, weighing 108.9 kg (239.5 pounds)

Reactions: Diabetes Mellitus, Thyroid Cancer, Blood Potassium Decreased, Dizziness

Drug(s) suspected as cause:
Salsalate
    Dosage: (1500 mg bid)
    Indication: Arthritis

Salsalate
    Dosage: (1500 mg bid)
    Indication: Pain

Metformin HCL
    Dosage: (50 mg qd)
    Indication: Diabetes Mellitus

Ascorbic Acid W / Vitamin D NOS
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Lipitor
    Dosage: (40 mg qd oral)
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Sulfasalazine
    Dosage: (100 mg bid)
    Indication: Arthritis

Sulfasalazine
    Dosage: (100 mg bid)
    Indication: Fibromyalgia

Lyrica
    Dosage: (1500 mg bid oral), (75 mg bid oral)
    Administration route: Oral
    Indication: Fibromyalgia

Cymbalta
    Dosage: (df)
    Indication: Depression

Citalopram Hydrobromide
    Dosage: (df)
    Indication: Depression

Levoxyl
    Dosage: (100 ug qd)
    Indication: Thyroid Therapy

Lomotil
    Dosage: (0.25 mg tid)
    Indication: Colitis
    Start date: 2011-02-01

Hydrochlorothiazide
    Dosage: (25 mg qd)
    Indication: Oedema Peripheral

Hydrochlorothiazide
    Dosage: (25 mg qd)
    Indication: Cardiac Disorder

Klor-CON
    Dosage: (20 meq qd) , (10 meq qd)
    Indication: Blood Potassium Decreased

Calcitriol
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication



Possible Calcitriol side effects in female

Reported by a health professional (non-physician/pharmacist) from Iran (Islamic Republic OF) on 2012-05-30

Patient: female

Reactions: Blood Pressure Systolic Decreased, Off Label Use, Blood Parathyroid Hormone Decreased

Drug(s) suspected as cause:
Calcitriol



Possible Calcitriol side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: 73 year old male, weighing 115.0 kg (253.0 pounds)

Reactions: Nausea, Dizziness, Blood Glucose Abnormal

Drug(s) suspected as cause:
Calcitriol
    Start date: 2012-01-13
    End date: 2012-02-06

Kombiglyze XR
    Dosage: 1 df= 2.5/1000 unit nos. with meals. started 10 days ago
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-01-01



Possible Calcitriol side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: 56 year old female, weighing 108.8 kg (239.4 pounds)

Reactions: Diabetes Mellitus, Blood Potassium Decreased, Thyroid Cancer, Dizziness

Drug(s) suspected as cause:
Lyrica
    Dosage: 75 mg, bid, oral : 150 mg, bid, oral : 75 mg, bid, oral
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2005-01-01

Citalopram Hydrobromide
    Indication: Depression

Calcitriol
    Indication: Product Used FOR Unknown Indication

Vitamin D
    Indication: Product Used FOR Unknown Indication

Levoxyl
    Dosage: 100 mcg, qd
    Indication: Thyroidectomy
    Start date: 2012-01-01

Cymbalta
    Indication: Depression

Sulfasalazine
    Dosage: 1000 mg, bid
    Indication: Arthritis

Lipitor
    Dosage: 40 mg, qd, oral
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Ascorbic Acid
    Indication: Product Used FOR Unknown Indication

Lomotil
    Dosage: 0.25 mg, tid
    Indication: Colitis

Hydrochlorothiazide
    Dosage: 25 mg,qd
    Indication: Oedema Peripheral

Klor-CON
    Dosage: 10 meq, qd : 20 meq, qd
    Indication: Blood Potassium Decreased

Salsalate (Salsalate)
    Dosage: 1500 mg, bid
    Indication: Arthritis

Metformin HCL
    Dosage: 50 mg, qd
    Indication: Diabetes Mellitus



Possible Calcitriol side effects in 59 year old female

Reported by a physician from France on 2012-05-18

Patient: 59 year old female

Reactions: Therapeutic Response Decreased, Pustular Psoriasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Colchicine
    Indication: Pustular Psoriasis

Acitretin
    Indication: Pustular Psoriasis

Adalimumab

Corticosteroids
    Administration route: Topical
    Indication: Pustular Psoriasis

Methotrexate

Ustekinumab
    Indication: Pustular Psoriasis

Methotrexate
    Indication: Pustular Psoriasis

Etanercept
    Indication: Pustular Psoriasis

Infliximab
    Indication: Pustular Psoriasis

Adalimumab
    Indication: Pustular Psoriasis
    End date: 2010-06-01

Calcitriol
    Indication: Pustular Psoriasis



Possible Calcitriol side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-02

Patient: female, weighing 109.0 kg (239.8 pounds)

Reactions: Thyroid Cancer, Diabetes Mellitus, Blood Potassium Decreased, Dizziness

Drug(s) suspected as cause:
Lyrica
    Dosage: 150 mg, 2x/day
    Administration route: Oral

Sulfasalazine
    Indication: Fibromyalgia

Citalopram
    Dosage: unk
    Indication: Depression

Cymbalta
    Dosage: unk
    Indication: Depression

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    Indication: Fibromyalgia

Hydrochlorothiazide
    Indication: Left Ventricular Dysfunction

Salsalate
    Dosage: 1500 mg, 2x/day
    Indication: Arthritis

Calcitriol
    Dosage: unk

Hydrochlorothiazide
    Dosage: 25 mg, daily
    Indication: Oedema Peripheral

Vitamin C
    Dosage: unk

Klor-CON
    Dosage: 20 meq, daily

Levoxyl
    Dosage: 100 ug, daily
    Indication: Thyroidectomy

Vitamin D
    Dosage: unk

Lipitor
    Dosage: 40 mg, daily
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Lomotil
    Dosage: ^0.25^ mg, 3x/day
    Indication: Colitis

Metformin HCL
    Dosage: 50 mg, daily
    Indication: Diabetes Mellitus

Sulfasalazine
    Dosage: 1000 mg, 2x/day
    Indication: Arthritis

Klor-CON
    Dosage: 10 meq, daily
    Indication: Blood Potassium Decreased



Possible Calcitriol side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: female, weighing 109.0 kg (239.8 pounds)

Reactions: Thyroid Cancer, Blood Potassium Decreased, Diabetes Mellitus, Dizziness

Drug(s) suspected as cause:
Hydrochlorothiazide
    Dosage: 25 mg, daily
    Indication: Oedema Peripheral

Hydrochlorothiazide
    Indication: Left Ventricular Dysfunction

Klor-CON
    Dosage: 20 meq, daily

Lyrica
    Dosage: 150 mg, 2x/day
    Administration route: Oral

Sulfasalazine
    Dosage: 1000 mg, 2x/day
    Indication: Arthritis

Klor-CON
    Dosage: 10 meq, daily
    Indication: Blood Potassium Decreased

Vitamin C
    Dosage: unk

Lipitor
    Dosage: 40 mg, daily
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Calcitriol
    Dosage: unk

Levoxyl
    Dosage: 100 ug, daily
    Indication: Thyroidectomy

Lomotil
    Dosage: ^0.25^ mg, 3x/day
    Indication: Colitis

Sulfasalazine
    Indication: Fibromyalgia

Cymbalta
    Dosage: unk
    Indication: Depression

Salsalate
    Dosage: 1500 mg, 2x/day
    Indication: Arthritis

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    Indication: Fibromyalgia

Citalopram
    Dosage: unk
    Indication: Depression

Metformin Hydrochloride
    Dosage: 50 mg, daily
    Indication: Diabetes Mellitus

Vitamin D
    Dosage: unk



Possible Calcitriol side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-04-27

Patient: 71 year old female

Reactions: Hypercalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcitriol
    Dosage: 0.5 ?g bid oral
    Administration route: Oral
    Indication: Thyroid Operation
    Start date: 2011-05-10
    End date: 2011-06-05

Calcium-Sandoz / 00751528 / (Calcium-Sandoz Calcium Glubionate) 500 MG (
    Dosage: oral
    Administration route: Oral
    Indication: Thyroid Operation
    Start date: 2011-05-10
    End date: 2011-06-05



Possible Calcitriol side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-04-17

Patient: male

Reactions: Hypercalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcitriol



Possible Calcitriol side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-04-17

Patient: female

Reactions: Confusional State, Hypercalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcitriol



Possible Calcitriol side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-04-17

Patient: male

Reactions: Hypercalcaemia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcitriol



Possible Calcitriol side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-04-17

Patient: female

Reactions: Coma, Epilepsy, Hypercalcaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Calcitriol



Possible Calcitriol side effects in female

Reported by a physician from Italy on 2012-03-21

Patient: female

Reactions: Femur Fracture, Coma, Hypercalcaemia, Convulsion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Calcium Carbonate
    Indication: Hypocalcaemia
    Start date: 2011-07-01
    End date: 2012-02-01

Calcitriol
    End date: 2012-02-01

Calcitriol
    Indication: Hypocalcaemia
    Start date: 2011-03-01
    End date: 2011-06-01

Calcium Carbonate
    End date: 2011-06-01

Other drugs received by patient: Keppra; Aspirin



Possible Calcitriol side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-03-09

Patient: female

Reactions: Coma, Hypercalcaemia, Convulsion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Calcitriol



Possible Calcitriol side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-03-08

Patient: female

Reactions: Coma, Epilepsy, Hypercalcaemia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Calcitriol



Possible Calcitriol side effects in female

Reported by a physician from Italy on 2012-03-06

Patient: female

Reactions: Femur Fracture, Coma, Hypercalcaemia, Convulsion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Calcium Carbonate
    Indication: Hypocalcaemia
    Start date: 2011-07-01
    End date: 2012-02-01

Calcium Carbonate
    End date: 2011-06-01

Calcitriol
    Indication: Hypocalcaemia
    Start date: 2011-03-01
    End date: 2011-06-01

Calcitriol
    End date: 2012-02-01

Other drugs received by patient: Keppra; Aspirin



Possible Calcitriol side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-03-05

Patient: male

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcitriol



Possible Calcitriol side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-17

Patient: 64 year old male

Reactions: Interstitial Granulomatous Dermatitis, Renal Impairment

Drug(s) suspected as cause:
Allopurinol
    Dosage: 100 mg, two times daily

Lorazepam

Potassium Citrate

Azithromycin

Amlodipine

Tamsulosin HCL

Ferrous Sulfate TAB

Furosemide

Docusate

Calcium

Hydroxyurea

Calcitriol

Lansoprazole



Possible Calcitriol side effects in

Reported by a health professional (non-physician/pharmacist) from China on 2012-02-10

Patient:

Reactions: Nephrolithiasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcitriol

Other drugs received by patient: Angiotensin Converting Enzyme (Ace) Inhibitor; Angiotensin Receptor Blocker (Arb)



Possible Calcitriol side effects in 9 year old male

Reported by a physician from Australia on 2012-02-03

Patient: 9 year old male

Reactions: Nephrocalcinosis

Drug(s) suspected as cause:
Calcitriol
    Dosage: 0.25 mcg twice daily
    Indication: Osteoporosis

Calcitriol
    Dosage: 0.25 mcg twice daily
    Indication: Spinal Compression Fracture

Pamidronate Disodium
    Dosage: 30 mg/m2, intravenous drip
    Indication: Spinal Compression Fracture

Pamidronate Disodium
    Dosage: 30 mg/m2, intravenous drip
    Indication: Osteoporosis

Other drugs received by patient: Calcium



Possible Calcitriol side effects in male

Reported by a physician from Australia on 2012-02-03

Patient: male

Reactions: Nephrocalcinosis

Drug(s) suspected as cause:
Pamidronate Disodium
    Dosage: 30 mg/m2 monthly, 30 mg/m2 twice monthly intravenous drip
    Indication: Osteogenesis Imperfecta

Calcitriol
    Dosage: 0.25 mcg twice daily
    Indication: Osteogenesis Imperfecta

Calcitriol
    Dosage: 0.25 mcg twice daily
    Indication: Multiple Fractures



Possible Calcitriol side effects in female

Reported by a physician from Australia on 2012-02-03

Patient: female

Reactions: Nephrocalcinosis

Drug(s) suspected as cause:
(Pamidronic Acid)
    Dosage: 30 mg/m^2 monthly, intravenous drip 30 mg/m^2 twice monthly

Calcitriol
    Dosage: 0.25 mcg twice monthly
    Indication: Osteogenesis Imperfecta



Possible Calcitriol side effects in male

Reported by a pharmacist from United States on 2012-01-23

Patient: male, weighing 74.5 kg (163.9 pounds)

Reactions: Mental Status Changes, Hypercalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calcitriol



Possible Calcitriol side effects in female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-01-18

Patient: female

Reactions: Dermatitis Bullous

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aranesp
    Indication: Renal Failure Chronic

Aranesp
    Dosage: 100 mug, unk
    Indication: Renal Failure
    Start date: 2011-01-01
    End date: 2011-01-01

Calcitriol
    Dosage: unk
    Start date: 2011-01-01
    End date: 2011-01-01



Possible Calcitriol side effects in 7 year old male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-01-17

Patient: 7 year old male

Reactions: Nephrocalcinosis

Drug(s) suspected as cause:
Pamidronate Disodium
    Dosage: unk

Calcitriol
    Dosage: 0.25 ug, 2x/day



Possible Calcitriol side effects in 2 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-01-17

Patient: 2 year old female

Reactions: Nephrocalcinosis

Drug(s) suspected as cause:
Calcitriol
    Dosage: 0.25 ug, 2x/day

Pamidronate Disodium
    Dosage: 30 mg/m2 monthly for 12 months, then 2 monthly for 12 months



Possible Calcitriol side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-01-10

Patient: 50 year old male

Reactions: Grand MAL Convulsion, Hypoglycaemia, Hyperinsulinaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Calcium Carbonate
    Dosage: (15 g intravenous (not otherwise specified))
    Indication: Blood Calcium Decreased

Calcitriol
    Dosage: (2 ug oral)
    Administration route: Oral
    Indication: Blood Calcium Decreased

Calcitriol
    Dosage: (2 ug oral)
    Administration route: Oral
    Indication: Hyperparathyroidism Secondary



Possible Calcitriol side effects in 84 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-19

Patient: 84 year old female

Reactions: Pruritus, Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mirtazapine
    Dosage: po
    Administration route: Oral
    Indication: Depression
    Start date: 2011-10-17

Calcitriol
    Dosage: once, po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-24
    End date: 2011-10-24

Other drugs received by patient: Potassium Chloride; Nitroglycerin; Cordarone; NEO-Mercazole TAB; Ramipril; Acetaminophen and Tramadol HCL; Moviprep; Previscan; Lasix; Bisoprolol Fumarate

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