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Restasis (Cyclosporine Ophthalmic) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Restasis (Cyclosporine Ophthalmic) 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 (731)
Death (5)
Life Threatening Events (2)
Disability (5)

Reports by Reaction Type

Eye Irritation (258)Vision Blurred (105)Eye Pain (99)Ocular Hyperaemia (86)Foreign Body Sensation in Eyes (60)Lacrimation Increased (50)Drug Ineffective (48)Eye Pruritus (34)Eye Discharge (33)DRY Eye (24)Eyelid Oedema (23)Headache (23)

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

Possible Restasis side effects in 83 year old female

Reported by a physician on 2012-08-24

Patient: 83 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Hallucination

Drug(s) suspected as cause:
Restasis



Possible Restasis side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Back Pain, Vomiting, Dyspnoea, Nausea, Drug Hypersensitivity, Abasia, Constipation, Skin Irritation, Myalgia, Fatigue, Insomnia, Asthenia, Blood Glucose Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Glucophage

Viagra

Motrin

Coreg

Xalatan

Tramadol Hydrochloride

Zetia

Toprol-XL

Plavix

Metformin Hydrochloride

Lotrimin

Proscar

Zocor

Luvox

Prozac

Restasis

Metoprolol Tartrate

Lipitor

Ibuprofen (Advil)

Reglan

Other drugs received by patient: Allopurinol; Omega-3-Acid Ethyl Esters; Pilocarpine; Istalol; Clozapine; Bilberry; Oxycodone HCL; Aspirin; Potassium Chloride; Lumigan; Pravastatin Sodium; Furosemide; Vicodin; Losartan Potassium; Digoxin; Folic Acid; Theratears; Diazepam; Lantus



Possible Restasis side effects in 66 year old female

Reported by a physician from United States on 2012-08-03

Patient: 66 year old female

Reactions: Eye Injury, Drug Ineffective, Abnormal Sensation in Eye, Ocular Hyperaemia, Visual Acuity Reduced

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Restasis

Other drugs received by patient: Sleeping Pill (Nos); Lisinopril; Humulin N; Lyrica; Furosemide; Lantus; Aspirin; Tylenol (Caplet); Carvedilol



Possible Restasis side effects in 80 year old female

Reported by a physician from United States on 2012-07-30

Patient: 80 year old female

Reactions: Rhinorrhoea

Drug(s) suspected as cause:
Lumigan
    Dosage: 2 gtt, qhs
    Indication: Glaucoma

Restasis
    Dosage: 2 gtt, bid
    Indication: DRY Eye
    Start date: 2012-02-21

Other drugs received by patient: Timolol Maleate



Possible Restasis side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Eye Irritation, Incorrect Dose Administered, Ocular Hyperaemia

Drug(s) suspected as cause:
Restasis
    Indication: DRY Eye

Latisse
    Dosage: unk
    Administration route: Topical
    Indication: Growth of Eyelashes



Possible Restasis side effects in 84 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 84 year old female

Reactions: Eye Irritation, Eye Discharge, Ocular Hyperaemia, Eye Pruritus

Drug(s) suspected as cause:
Lumigan
    Dosage: unk
    Indication: Glaucoma

Restasis
    Dosage: unk, unk
    Indication: DRY Eye
    Start date: 2009-05-01

Other drugs received by patient: Combigan



Possible Restasis side effects in 84 year old male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 84 year old male

Reactions: Iris Hyperpigmentation, Drug Ineffective

Drug(s) suspected as cause:
Lumigan
    Dosage: unk
    Indication: Glaucoma

Restasis
    Dosage: 1 gtt, bid
    Indication: DRY Eye
    Start date: 2009-01-01

Other drugs received by patient: Zocor



Possible Restasis side effects in 68 year old male

Reported by a pharmacist from Australia on 2012-07-20

Patient: 68 year old male

Reactions: Keratitis Bacterial

Drug(s) suspected as cause:
Restasis



Possible Restasis side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 77 year old female

Reactions: Basal Cell Carcinoma, Vision Blurred, Instillation Site Pain

Drug(s) suspected as cause:
Restasis

Other drugs received by patient: Propylene Glycol; Genteal; Blank Gel Tears



Possible Restasis side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17

Patient: male

Reactions: Sleep Disorder, Insomnia

Drug(s) suspected as cause:
Restasis



Possible Restasis side effects in 28 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-10

Patient: 28 year old female, weighing 69.4 kg (152.7 pounds)

Reactions: Headache

Drug(s) suspected as cause:
Restasis



Possible Restasis side effects in 63 year old male

Reported by a physician from United States on 2012-07-02

Patient: 63 year old male

Reactions: Squamous Cell Carcinoma

Drug(s) suspected as cause:
Restasis



Possible Restasis side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: 53 year old female

Reactions: Upper Respiratory Tract Infection, Eyelid Bleeding

Drug(s) suspected as cause:
Latisse
    Dosage: 2 gtt, unk
    Administration route: Topical
    Indication: Growth of Eyelashes

Restasis
    Dosage: 2 gtt, bid
    Indication: DRY Eye

Other drugs received by patient: Artificial Tears / 00445101 /



Possible Restasis side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: 64 year old female

Reactions: Nasopharyngeal Cancer

Drug(s) suspected as cause:
Restasis

Other drugs received by patient: Evista



Possible Restasis side effects in 68 year old male

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: 68 year old male, weighing 97.5 kg (214.6 pounds)

Reactions: Adverse Event

Drug(s) suspected as cause:
Restasis



Possible Restasis side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: 59 year old female, weighing 61.7 kg (135.7 pounds)

Reactions: Eyelid Oedema, Drug Hypersensitivity, Ocular Hyperaemia, Eye Swelling

Drug(s) suspected as cause:
Restasis
    Dosage: 1 drop 2 times a day opthalmic
    Indication: DRY Eye
    Start date: 2012-04-04
    End date: 2012-05-08

Restasis
    Dosage: 1 drop 2 times a day opthalmic
    Indication: DRY Eye
    Start date: 2012-05-31
    End date: 2012-06-02

Other drugs received by patient: Thera Tear Lubricant



Possible Restasis side effects in 89 year old female

Reported by a physician from United States on 2012-06-10

Patient: 89 year old female

Reactions: Wrong Technique in Drug Usage Process, Eye Discharge, Vision Blurred, Eye Pain

Drug(s) suspected as cause:
FML Forte
    Indication: Eye Discharge

Restasis
    Dosage: 2 gtt, bid
    Indication: DRY Eye
    Start date: 2012-03-12

Restasis
    Indication: Eye Pain

FML Forte
    Indication: Eye Pain

Restasis
    Indication: Eye Discharge

FML Forte
    Dosage: 2 gtt, bid
    Indication: Eye Infection
    Start date: 2012-03-12



Possible Restasis side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: 71 year old male, weighing 107.0 kg (235.4 pounds)

Reactions: Back Pain, Vomiting, Dyspnoea, Nausea, Drug Hypersensitivity, Abasia, Constipation, Skin Irritation, Myalgia, Fatigue, Insomnia, Asthenia, Blood Glucose Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Metoprolol Tartrate
    Indication: Hypertension
    Start date: 2009-01-01

Plavix

Zocor

Reglan

Coreg

Tramadol HCL

Glucophage

Luvox

Ibuprofen (Advil)
    Indication: Back Pain
    End date: 2011-03-01

Motrin

Metformin HCL
    Indication: Diabetes Mellitus
    Start date: 2010-10-18

Proscar

Viagra

Toprol-XL

Restasis

Lotrimin

Xalatan

Prozac

Lipitor

Zetia

Other drugs received by patient: Furosemide; Pravastatin Sodium; Potassium Chloride; Pilocarpine; Diazepam; Losartan; Theratears; Lantus; Clozapine; Aspirin; Lumigan; Istalol; Folic Acid; Vicodin; Bilberry; Digoxin; Oxycodone HCL; Fish OIL; Allopurinol



Possible Restasis side effects in 80 year old female

Reported by a physician from United States on 2012-06-08

Patient: 80 year old female

Reactions: Abdominal Discomfort, Nausea, Dizziness, Headache, Pemphigoid

Drug(s) suspected as cause:
Restasis



Possible Restasis side effects in 83 year old male

Reported by a physician from United States on 2012-06-01

Patient: 83 year old male

Reactions: Extranodal Marginal Zone B-Cell Lymphoma (Malt Type), Keratitis Herpetic

Drug(s) suspected as cause:
Restasis



Possible Restasis side effects in 64 year old female

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

Patient: 64 year old female, weighing 52.2 kg (114.8 pounds)

Reactions: Insomnia

Drug(s) suspected as cause:
Restasis
    Dosage: one vial twice daily ophthalmic
    Indication: DRY Eye
    Start date: 2012-05-05
    End date: 2012-05-20

Restasis
    Dosage: one vial twice daily ophthalmic
    Indication: DRY Eye
    Start date: 2011-11-20
    End date: 2012-03-10



Possible Restasis side effects in 77 year old female

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

Patient: 77 year old female

Reactions: Basal Cell Carcinoma, Vision Blurred, Instillation Site Pain

Drug(s) suspected as cause:
Restasis

Other drugs received by patient: Propylene Glycol; Genteal; Blank Gel Tears



Possible Restasis side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: 76 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Burning Sensation, Skin Exfoliation, DRY Mouth, DRY Eye, Eye Pain

Drug(s) suspected as cause:
Spiriva
    Dosage: 1 capsule once a day inhaler
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-02-01
    End date: 2012-02-01

Restasis
    Dosage: 1 drop twice a day both eyes
    Indication: DRY Eye
    Start date: 2011-07-01
    End date: 2012-02-01



Possible Restasis side effects in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: 69 year old male, weighing 102.0 kg (224.4 pounds)

Reactions: Back Pain, Dyspnoea, Chest Discomfort, Vomiting, Nausea, Abasia, Drug Hypersensitivity, Constipation, Myalgia, Fatigue, Arthropathy, Sleep Disorder, Asthenia, Blood Glucose Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Plavix

Coreg
    Indication: Cardiac Disorder

Lipitor

Alprazolam

Glyburide
    Indication: Diabetes Mellitus

Glucophage

Zetia
    Administration route: Oral

Codeine

Tramadol HCL

Reglan

Viagra

Zocor
    Administration route: Oral

Metformin HCL
    Indication: Diabetes Mellitus
    Start date: 2010-10-18

Lotrimin

Advil
    End date: 2010-01-01

Toprol-XL

Prozac

Motrin

Xalatan

Proscar
    Administration route: Oral

Restasis

Luvox

Advil
    Indication: Back Pain
    Start date: 2011-03-01
    End date: 2011-03-01

Other drugs received by patient: Losartan Potassium; Lantus; Clozapine; Oxycodone; Aspirin; Digoxin; Allopurinol; Metoprolol Tartrate; Bilberry; Furosemide; Lumigan; Pravastatin Sodium; Omega-3 Marine Triglycerides; Vicodin; Potassium Chloride; Folic Acid; Diazepam; Pilocarpine; Istalol; Aspirin; Thera Tears



Possible Restasis side effects in 60 year old female

Reported by a physician from United States on 2012-05-28

Patient: 60 year old female

Reactions: Progressive Multifocal Leukoencephalopathy

Drug(s) suspected as cause:
Restasis
    Dosage: 2 gtt, bid
    Indication: Sjogren's Syndrome
    Start date: 2010-06-03
    End date: 2010-12-10

Restasis
    Indication: DRY Eye

Other drugs received by patient: Mefloquine Hydrochloride; Mirtazapine; Enjuvia; Citalopram Hydrobromide; Multi-Vitamins



Possible Restasis side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: 53 year old female

Reactions: Upper Respiratory Tract Infection, Eyelid Bleeding

Drug(s) suspected as cause:
Latisse
    Dosage: 2 gtt, unk
    Administration route: Topical
    Indication: Growth of Eyelashes

Restasis
    Dosage: 2 gtt, bid
    Indication: DRY Eye

Other drugs received by patient: Artificial Tears / 00445101 /



Possible Restasis side effects in 60 year old female

Reported by a physician from United States on 2012-05-22

Patient: 60 year old female

Reactions: Progressive Multifocal Leukoencephalopathy

Drug(s) suspected as cause:
Restasis

Other drugs received by patient: Mefloquine Hydrochloride; Mirtazapine



Possible Restasis side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-05-03

Patient: 79 year old female

Reactions: Visual Impairment

Drug(s) suspected as cause:
Lotemax
    Indication: Eye Oedema
    Start date: 2011-02-01
    End date: 2011-02-01

Lotemax
    Start date: 2011-02-01
    End date: 2011-04-06

Restasis
    Indication: DRY Eye
    Start date: 2010-01-01
    End date: 2011-04-01



Possible Restasis side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient: female, weighing 81.6 kg (179.6 pounds)

Reactions: Disturbance in Sexual Arousal, Drug Interaction

Drug(s) suspected as cause:
Restasis



Possible Restasis side effects in 77 year old female

Reported by a consumer/non-health professional from United States on 2012-04-13

Patient: 77 year old female, weighing 74.8 kg (164.7 pounds)

Reactions: Vertigo

Drug(s) suspected as cause:
Restasis

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