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Cyclosporine Side Effects

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Common Cyclosporine Side Effects


The most commonly reported Cyclosporine side effects (click to view or check a box to report):

Pyrexia (292)
Blood Creatinine Increased (288)
Cytomegalovirus Infection (237)
Graft Versus Host Disease (216)
Diarrhoea (176)
Dyspnoea (146)
Chronic Graft Versus Host Disease (145)
Convulsion (145)
Hypertension (143)
Renal Impairment (140)
Acute Graft Versus Host Disease (132)
Kidney Transplant Rejection (132)
Abdominal Pain (131)
Multi-organ Failure (129)
Nephropathy Toxic (129)
Anaemia (122)
Acute Graft Versus Host Disease In Skin (121)
Thrombotic Microangiopathy (120)
Epstein-barr Virus Infection (115)
Pneumonia (114)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Cyclosporine Side Effects Reported to FDA



Cyclosporine Side Effect Report#9928534
Anaphylactic Reaction, Oxygen Saturation Decreased, Blood Pressure Systolic Decreased
This is a report of a 4-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Cyclosporine (dosage: ;qd;ivdrp, start time: NS), combined with:
  • Cyclosporine Oral Solution
and developed a serious reaction and side effect(s): Anaphylactic Reaction, Oxygen Saturation Decreased, Blood Pressure Systolic Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cyclosporine treatment in male patients, resulting in Anaphylactic Reaction side effect. The patient was hospitalized.
Cyclosporine Side Effect Report#9889373
Transplant Rejection, Toxicity To Various Agents, Renal Impairment, White Blood Cell Count Decreased, Platelet Count Decreased
This report suggests a potential Cyclosporine Transplant Rejection side effect(s) that can have serious consequences. A 26-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: immunosuppression and used Cyclosporine (dosage: NA) starting NS. After starting Cyclosporine the patient began experiencing various side effects, including: Transplant Rejection, Toxicity To Various Agents, Renal Impairment, White Blood Cell Count Decreased, Platelet Count DecreasedAdditional drugs used concurrently:
  • Ribavirin
  • Prednisone
  • Immunoglobulin (2 Doses)
  • Posaconazole
  • Valganciclovir
  • Trimethoprim Sulfamethoxazole
  • Tacrolimus
  • Mycophenolate Mofetil
Although Cyclosporine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Transplant Rejection, may still occur.
Cyclosporine Side Effect Report#9869469
Leukoencephalopathy, Trismus, Convulsion, Epilepsy, Fungal Infection
This Leukoencephalopathy problem was reported by a physician from CN. A 18-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis against transplant rejection. On NS this consumer started treatment with Cyclosporine (dosage: NA). The following drugs were being taken at the same time:
  • Voriconazole
When using Cyclosporine, the patient experienced the following unwanted symptoms/side effects: Leukoencephalopathy, Trismus, Convulsion, Epilepsy, Fungal InfectionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Leukoencephalopathy, may become evident only after a product is in use by the general population.
Cyclosporine Side Effect Report#9837783
Neoplasm Skin
This Neoplasm Skin side effect was reported by a pharmacist from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: renal transplant.The patient was prescribed Cyclosporine (drug dosage: NA), which was initiated on 201208. Concurrently used drugs:
  • Mycophenolate
.After starting to take Cyclosporine the consumer reported adverse symptoms, such as: Neoplasm SkinThese side effects may potentially be related to Cyclosporine.
Cyclosporine Side Effect Report#9760188
Ocular Vascular Disorder, Retinoblastoma, Recurrent Cancer, Arteriosclerotic Retinopathy, Chorioretinal Disorder
This is a report of a 3-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: retinoblastoma, who was treated with Cyclosporine (dosage: NA, start time: NS), combined with:
  • Carboplatin
  • Etoposide
  • Vincristine
and developed a serious reaction and side effect(s): Ocular Vascular Disorder, Retinoblastoma, Recurrent Cancer, Arteriosclerotic Retinopathy, Chorioretinal Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cyclosporine treatment in female patients, resulting in Ocular Vascular Disorder side effect.
Cyclosporine Side Effect Report#9723087
Ventricular Tachyarrhythmia, Device Pacing Issue, Hypoglycaemia
This report suggests a potential Cyclosporine Ventricular Tachyarrhythmia side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: systemic lupus erythematosus,protein-losing gastroenteropathy,left ventricular end-diastolic pressure and used Cyclosporine (dosage: NA) starting NS. After starting Cyclosporine the patient began experiencing various side effects, including: Ventricular Tachyarrhythmia, Device Pacing Issue, HypoglycaemiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Cyclosporine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Ventricular Tachyarrhythmia, may still occur.
Cyclosporine Side Effect Report#9716500
Brucellosis, Brucellosis
This Brucellosis problem was reported by a physician from Country Not Specified. A 56-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: immunosuppression. On NS this consumer started treatment with Cyclosporine (dosage: NA). The following drugs were being taken at the same time:
  • Azathioprine
  • Prednisolone
When using Cyclosporine, the patient experienced the following unwanted symptoms/side effects: Brucellosis, BrucellosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Brucellosis, may become evident only after a product is in use by the general population.
Cyclosporine Side Effect Report#9716490
Brucellosis, Arthritis Infective, Brucellosis
This Brucellosis side effect was reported by a physician from Country Not Specified. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: immunosuppression.The patient was prescribed Cyclosporine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Azathioprine
  • Prednisolone
.After starting to take Cyclosporine the consumer reported adverse symptoms, such as: Brucellosis, Arthritis Infective, BrucellosisThese side effects may potentially be related to Cyclosporine.
Cyclosporine Side Effect Report#9704740
Cerebral Vasoconstriction
This is a report of a 62-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Cyclosporine (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Cerebral Vasoconstriction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cyclosporine treatment in female patients, resulting in Cerebral Vasoconstriction side effect. The patient was hospitalized.
Cyclosporine Side Effect Report#9681340
Necrotising Fasciitis
This report suggests a potential Cyclosporine Necrotising Fasciitis side effect(s) that can have serious consequences. A 4-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: histiocytosis haematophagic and used Cyclosporine (dosage: NA) starting NS. After starting Cyclosporine the patient began experiencing various side effects, including: Necrotising FasciitisAdditional drugs used concurrently:
  • Etanercept
  • Acyclovir
The patient was hospitalized. Although Cyclosporine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Necrotising Fasciitis, may still occur.
Cyclosporine Side Effect Report#9665444
Blood Creatinine Increased
This Blood Creatinine Increased problem was reported by a pharmacist from US. A 64-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: immunosuppression. On
Aug 15, 2011 this consumer started treatment with Cyclosporine (dosage: NA). The following drugs were being taken at the same time:
  • Piperacillin/tazobactam
  • Metoprolol
  • Levothyroxine
  • Fluconazole
  • Ranitidine
  • Mycophenolate
When using Cyclosporine, the patient experienced the following unwanted symptoms/side effects: Blood Creatinine IncreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blood Creatinine Increased, may become evident only after a product is in use by the general population.
Cyclosporine Side Effect Report#9587237
Posterior Reversible Encephalopathy Syndrome, T-cell Type Acute Leukaemia
This Posterior Reversible Encephalopathy Syndrome side effect was reported by a health professional from US. A 18-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Cyclosporine (watson Laboratories) (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Tacrolimus (watson Laboratories) (1 Mg, Bid)
  • Muromonab-cd3
.After starting to take Cyclosporine (watson Laboratories) the consumer reported adverse symptoms, such as: Posterior Reversible Encephalopathy Syndrome, T-cell Type Acute LeukaemiaThese side effects may potentially be related to Cyclosporine (watson Laboratories).
Cyclosporine Side Effect Report#9548120
Accidental Overdose, Grand Mal Convulsion
This is a report of a 18-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: bone marrow transplant, who was treated with Cyclosporine (dosage: 3.57mg/kg/day (usual Dose Is 2.5mg/kg), start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Accidental Overdose, Grand Mal Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cyclosporine treatment in female patients, resulting in Accidental Overdose side effect.
Cyclosporine Side Effect Report#9548077
Accidental Overdose, Brain Oedema, Mydriasis, Intracranial Pressure Increased
This report suggests a potential Cyclosporine Accidental Overdose side effect(s) that can have serious consequences. A 51-year-old male patient (weight: NA) from CH was diagnosed with the following symptoms/conditions: lung transplant and used Cyclosporine (dosage: NA) starting NS. After starting Cyclosporine the patient began experiencing various side effects, including: Accidental Overdose, Brain Oedema, Mydriasis, Intracranial Pressure IncreasedAdditional drugs used concurrently: NA. Although Cyclosporine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Accidental Overdose, may still occur.
Cyclosporine Side Effect Report#9516788
Suicidal Ideation, Overdose, Cerebral Disorder
This Suicidal Ideation problem was reported by a health professional from Country Not Specified. A 20-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Cyclosporine (dosage: NA). The following drugs were being taken at the same time: NA. When using Cyclosporine, the patient experienced the following unwanted symptoms/side effects: Suicidal Ideation, Overdose, Cerebral DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Suicidal Ideation, may become evident only after a product is in use by the general population.
Cyclosporine Side Effect Report#9504515
Renal Failure Acute, Graft Versus Host Disease
This Renal Failure Acute side effect was reported by a health professional from Country Not Specified. A 34-year-old male patient (weight:NA) experienced the following symptoms/conditions: prophylaxis against graft versus host disease.The patient was prescribed Cyclosporine (drug dosage: 2 Mg/kg Daily Starting At Day 1 After Hsct), which was initiated on NS. Concurrently used drugs: NA..After starting to take Cyclosporine the consumer reported adverse symptoms, such as: Renal Failure Acute, Graft Versus Host DiseaseThese side effects may potentially be related to Cyclosporine.
Cyclosporine Side Effect Report#9503978
Depression, Mood Swings, Suicidal Ideation
This is a report of a 24-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: psoriasis, who was treated with Cyclosporine (dosage: 4 Capsules 1xd By Mouth, start time:
Aug 10, 2013), combined with:
  • Nexplanon
  • Pristiq
  • Topimax
  • Nasonex
  • Zyrtec
  • Talconex
  • Clobetasol
  • Multivites
and developed a serious reaction and side effect(s): Depression, Mood Swings, Suicidal Ideation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cyclosporine treatment in female patients, resulting in Depression side effect.
Cyclosporine Side Effect Report#9464340
Cytomegalovirus Infection
This report suggests a potential Cyclosporine Cytomegalovirus Infection side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: pustular psoriasis and used Cyclosporine (dosage: NA) starting NS. After starting Cyclosporine the patient began experiencing various side effects, including: Cytomegalovirus InfectionAdditional drugs used concurrently:
  • Acitretin
  • Steroids
  • Mesalazine
Although Cyclosporine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cytomegalovirus Infection, may still occur.
Cyclosporine Side Effect Report#9454497
Acute Graft Versus Host Disease In Intestine, Acute Graft Versus Host Disease In Liver, Chronic Graft Versus Host Disease In Skin
This Acute Graft Versus Host Disease In Intestine problem was reported by a health professional from Country Not Specified. A 24-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Cyclosporine (dosage: NA). The following drugs were being taken at the same time: NA. When using Cyclosporine, the patient experienced the following unwanted symptoms/side effects: Acute Graft Versus Host Disease In Intestine, Acute Graft Versus Host Disease In Liver, Chronic Graft Versus Host Disease In SkinAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Acute Graft Versus Host Disease In Intestine, may become evident only after a product is in use by the general population.
Cyclosporine Side Effect Report#9435265
Toxicity To Various Agents, Cardiomyopathy, Rhabdomyolysis, Hepatotoxicity, Neuropathy Peripheral, Neutropenia, Diarrhoea
This Toxicity To Various Agents side effect was reported by a physician from Country Not Specified. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: immunosuppression,gout.The patient was prescribed Cyclosporine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Colchicine
  • Darbepoetin Alfa
  • Clonidine
  • Amlodipine
  • Clopidogrel
  • Lansoprazole
  • Furosemide
  • Ramipril
.After starting to take Cyclosporine the consumer reported adverse symptoms, such as: Toxicity To Various Agents, Cardiomyopathy, Rhabdomyolysis, Hepatotoxicity, Neuropathy Peripheral, Neutropenia, DiarrhoeaThese side effects may potentially be related to Cyclosporine. The patient was hospitalized.
Cyclosporine Side Effect Report#9391133
Hypoperfusion, Renal Disorder
This is a report of a 61-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Cyclosporine (dosage: 100mg Bid Po, start time:
Feb 20, 2013), combined with: NA. and developed a serious reaction and side effect(s): Hypoperfusion, Renal Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cyclosporine treatment in female patients, resulting in Hypoperfusion side effect.
Cyclosporine Side Effect Report#9373235
Human Herpesvirus 8 Infection, Human Herpesvirus 8 Infection
This report suggests a potential Cyclosporine Human Herpesvirus 8 Infection side effect(s) that can have serious consequences. A 43-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: NA and used Cyclosporine (dosage: NA) starting NS. After starting Cyclosporine the patient began experiencing various side effects, including: Human Herpesvirus 8 Infection, Human Herpesvirus 8 InfectionAdditional drugs used concurrently:
  • Corticosteroids
  • Corticosteroids
The patient was hospitalized. Although Cyclosporine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Human Herpesvirus 8 Infection, may still occur.
Cyclosporine Side Effect Report#9365115
Pulmonary Arterial Hypertension, Blood Creatinine Increased
This Pulmonary Arterial Hypertension problem was reported by a health professional from Country Not Specified. A 49-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: antisynthetase syndrome. On NS this consumer started treatment with Cyclosporine (dosage: NA). The following drugs were being taken at the same time: NA. When using Cyclosporine, the patient experienced the following unwanted symptoms/side effects: Pulmonary Arterial Hypertension, Blood Creatinine IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Arterial Hypertension, may become evident only after a product is in use by the general population.
Cyclosporine Side Effect Report#9365113
Pulmonary Arterial Hypertension, Blood Creatinine Increased, Hypertension
This Pulmonary Arterial Hypertension side effect was reported by a health professional from Country Not Specified. A 72-year-old female patient (weight:NA) experienced the following symptoms/conditions: antisynthetase syndrome.The patient was prescribed Cyclosporine (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Cyclosporine the consumer reported adverse symptoms, such as: Pulmonary Arterial Hypertension, Blood Creatinine Increased, HypertensionThese side effects may potentially be related to Cyclosporine.
Cyclosporine Side Effect Report#9358472
Glomerulosclerosis, Nephropathy Toxic, Therapeutic Response Decreased
This is a report of a 15-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: immunosuppression, who was treated with Cyclosporine (dosage: NA, start time: NS), combined with:
  • Methylprednisolone (3 Consecutive Days On Weeks 1, 3 And 5, Then Monthly Til 6 Months)
  • Methylprednisolone (20 Mg/body/d, Tapered Weekly To 4 Mg/d At Week 5, Then Alternate Day Administration)
  • Mmf
  • Basiliximab (Day 0 And Day 4)
and developed a serious reaction and side effect(s): Glomerulosclerosis, Nephropathy Toxic, Therapeutic Response Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cyclosporine treatment in female patients, resulting in Glomerulosclerosis side effect.


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The appearance of Cyclosporine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Cyclosporine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Cyclosporine Side Effects

    Did You Have a Cyclosporine Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Cyclosporine for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
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    Cyclosporine Safety Alerts, Active Ingredients, Usage Information

    NDC0172-7310
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameCyclosporine
    NameCyclosporine
    Dosage FormCAPSULE, LIQUID FILLED
    RouteORAL
    On market since20050329
    LabelerIVAX Pharmaceuticals, Inc.
    Active Ingredient(s)CYCLOSPORINE
    Strength(s)25
    Unit(s)mg/1
    Pharma ClassCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhib

    Cyclosporine Dosage, Warnings, Usage.

    Side Effects reported to FDA: 4457

    Cyclosporine safety alerts: 2000

    Reported deaths: 1608

    Reported hospitalizations: 1742

    SangCya (Cyclosporine Oral Solution, USP (MODIFIED))

    Health professionals are notified of a voluntary recall of SangCya (Cyclosporine Oral Solution, USP (MODIFIED), 100mg/mL), 50 mL bottle. A study in healthy volunteers has identified that SangCya is not bioequivalent to Neoral oral solution when mixed with apple juice as recommended in its labeling. SangStat is taking this Class II recall action with the knowledge of the FDA.

    [July 10, 2000 - Health Professional Letter - SangStat Medical Corporation]
    [July 10, 2000 - Wholesale Dist. Letter - SangStat Medical Corporation]

     

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