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 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 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 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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