ADVERSE REACTIONS
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS).
- Thrombophlebitis
- Arterial thromboembolism
- Pulmonary embolism
- Myocardial infarction
- Cerebral hemorrhage
- Cerebral thrombosis
- Hypertension
- Gallbladder disease
- Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:
- Mesenteric thrombosis
- Retinal thrombosis
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
- Nausea
- Vomiting
- Gastrointestinal symptoms (such as abdominal cramps and bloating)
- Breakthrough bleeding
- Spotting
- Change in menstrual flow
- Amenorrhea
- Temporary infertility after discontinuation of treatment
- Edema
- Melasma which may persist
- Breast changes: tenderness, enlargement, secretion
- Change in weight (increase or decrease)
- Change in cervical erosion and secretion
- Diminution in lactation when given immediately postpartum
- Cholestatic jaundice
- Migraine
- Rash (allergic)
- Mental depression
- Reduced tolerance to carbohydrates
- Vaginal candidiasis
- Change in corneal curvature (steepening)
- lntolerance to contact lenses
The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted:
- Acne
- Budd-Chiari syndrome
- Cataracts
- Changes in appetite
- Changes in libido
- Colitis
- Cystitis-like syndrome
- Dizziness
- Erythema multiforme
- Erythema nodosum
- Headache
- Hemolytic uremic syndrome
- Hemorrhagic eruption
- Hirsutism
- Impaired renal function
- Loss of scalp hair
- Nervousness
- Porphyria
- Pre-menstrual syndrome
- Vaginitis
The following are the most common adverse events reported with use of YASMIN during the clinical trials, occurring in > 1% of subjects and which may or may not be drug related: Headache, Menstrual Disorder, Breast Pain, Abdominal Pain, Nausea, Leukorrhea, Flu Syndrome, Acne, Vaginal Moniliasis, Depression, Diarrhea, Asthenia, Dysmenorrhea, Back Pain, Infection, Pharyngitis, Intermenstrual Bleeding, Migraine, Vomiting, Dizziness, Nervousness, Vaginitis, Sinusitis, Cystitis, Bronchitis, Gastroenteritis, Allergic Reaction, Urinary Tract Infection, Pruritus, Emotional Lability, Surgery, Rash, Upper Respiratory Infection.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO YASMIN
Below is a sample of reports where side effects / adverse reactions may be related to Yasmin. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Yasmin side effects / adverse reactions in 19 year old female
Reported by a consumer/non-health professional from United States on 2007-01-09
Patient: 19 year old female weighing 59.0 kg (129.8 pounds)
Reactions: Gallbladder Pain, Gastrointestinal Disorder, Scar
Adverse event resulted in: hospitalization
Suspect drug(s):
Yasmin
Other drugs received by patient: Lexapro; Lorazepam
Possible Yasmin side effects / adverse reactions in 49 year old female
Reported by a consumer/non-health professional from United States on 2007-01-11
Patient: 49 year old female weighing 90.7 kg (199.6 pounds)
Reactions: Pulmonary Embolism, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Yasmin
Possible Yasmin side effects / adverse reactions in 22 year old female
Reported by a pharmacist from United States on 2007-01-12
Patient: 22 year old female weighing 100.0 kg (220.0 pounds)
Reactions: Dyspnoea, Fibrin D Dimer Increased, Chest Pain, Pulmonary Embolism
Adverse event resulted in: hospitalization
Suspect drug(s):
Yasmin
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