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Contraceptives Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 45 

Dyspepsia, Abdominal Pain Upper, Haematemesis (8553402-6)
on Jun 19, 2011 Female from UNITED STATES , 26 years of age, was treated with Contraceptives Nos. Directly after, patient experienced the unwanted or unexpected Contraceptives side effects: dyspepsia, abdominal pain upper, haematemesis. Contraceptives Nos dosage: N/A.
Associated medications used:
  • Ortho Tri-cyclen Lo
  • Aleve (2df / Oral)


Pregnancy, Amniocentesis, Amniocentesis Normal (8479538-6)
Patient was taking Contraceptives. Patient felt the following Contraceptives side effects: pregnancy, amniocentesis, amniocentesis normal on Jun 20, 2012 from KOREA, REPUBLIC OF Additional patient health information: Female , 42 years of age, weighting 116.8 lb, . Contraceptives dosage: N/A.
Multiple prescriptions taken:
  • Act-293987 (200 ?g, Qd)
  • Tracleer (Unk)
  • Act-293987 (400 ?g, Bid)
  • Act-293987 (200 ?g, Bid)


Oral Herpes, Cytotoxic Oedema, Demyelination, Visual Impairment, White Blood Cell Count Decreased, Encephalopathy, Multiple Sclerosis Relapse, Aphasia, Dysphonia (8402067-2)
Adverse event was reported on May 25, 2012 by a Female taking Contraceptives Nos (Dosage: N/A) . Location: CZECH REPUBLIC , 30 years of age, After Contraceptives was administered, patient encountered several Contraceptives side effects: oral herpes, cytotoxic oedema, demyelination, visual impairment, white blood cell count decreased, encephalopathy, multiple sclerosis relapse, aphasia, dysphonia.
Multiple concurrent drugs taken:
  • Gilenya (0.5 Mg, Unk)
Patient was hospitalized.

Cold Sweat, Hyperventilation, Presyncope, Peripheral Coldness, Bradycardia, Pallor, Musculoskeletal Pain (8376430-2)
on May 17, 2012 Female from SPAIN , 30 years of age, was treated with Contraceptives. Directly after, patient experienced the unwanted or unexpected Contraceptives side effects: cold sweat, hyperventilation, presyncope, peripheral coldness, bradycardia, pallor, musculoskeletal pain. Contraceptives dosage: N/A.
Associated medications used:
  • Gilenya (0.5 Mg, Qd)



Suture Rupture, Intervertebral Disc Protrusion (8365785-0)
on May 04, 2012 Female from BELGIUM , 42 years of age, weighting 136.7 lb, was treated with Contraceptives For Topical Use. Patient felt the following Contraceptives side effects: suture rupture, intervertebral disc protrusion. Contraceptives For Topical Use dosage: Unk.
Multiple prescriptions taken:
  • Enbrel (50 Mg, Weekly)
Patient was hospitalized.

Vision Blurred, Hyperhidrosis, Hypertension (8352859-3)
Patient was taking Contraceptives. After Contraceptives was administered, patient encountered several Contraceptives side effects: vision blurred, hyperhidrosis, hypertension on Apr 30, 2012 from UNITED STATES Additional patient health information: Female , 16 years of age, weighting 135.0 lb, . Contraceptives dosage: N/A.
Multiple concurrent drugs taken:
  • Strattera (40 Mg, Unk)
  • Strattera (60 Mg, Unk)


Blood Fibrinogen Decreased, Hemianopia, White Blood Cell Count Decreased, Encephalopathy, Hemiparesis, Multiple Sclerosis Relapse, Cytotoxic Oedema, Demyelination, Lymphocyte Count Decreased (8329589-7)
Adverse event was reported on Apr 24, 2012 by a Female taking Contraceptives Nos (Dosage: N/A) . Location: CZECH REPUBLIC , 30 years of age, Directly after, patient experienced the unwanted or unexpected Contraceptives side effects: blood fibrinogen decreased, hemianopia, white blood cell count decreased, encephalopathy, hemiparesis, multiple sclerosis relapse, cytotoxic oedema, demyelination, lymphocyte count decreased.
Associated medications used:
  • Gilenya (0.5 Mg, Unk)
Patient was hospitalized.

Demyelination, White Blood Cell Count Decreased, Lymphocyte Count Decreased, Cytotoxic Oedema, Dysphonia, Visual Impairment, Encephalopathy, Multiple Sclerosis Relapse (8305836-2)
on Apr 17, 2012 Female from CZECH REPUBLIC , 30 years of age, was treated with Contraceptives Nos. Patient felt the following Contraceptives side effects: demyelination, white blood cell count decreased, lymphocyte count decreased, cytotoxic oedema, dysphonia, visual impairment, encephalopathy, multiple sclerosis relapse. Contraceptives Nos dosage: N/A.
Multiple prescriptions taken:
  • Gilenya (0.5 Mg, Unk)
Patient was hospitalized.

Emotional Distress, Renal Vein Thrombosis, Injury, Pain, Anxiety (8304413-7)
on Apr 16, 2012 Female from UNITED STATES , 17 years of age, weighting 119.0 lb, was treated with Contraceptives Nos. After Contraceptives was administered, patient encountered several Contraceptives side effects: emotional distress, renal vein thrombosis, injury, pain, anxiety. Contraceptives Nos dosage: N/A.
Multiple concurrent drugs taken:
  • Yasmin (Unk)
  • Yaz
Patient was hospitalized.

Aphasia, Oral Herpes, Cytotoxic Oedema, Visual Impairment, Dysphonia, Encephalopathy, Multiple Sclerosis Relapse, Hemiparesis (8283658-9)
Patient was taking Contraceptives Nos. Directly after, patient experienced the unwanted or unexpected Contraceptives side effects: aphasia, oral herpes, cytotoxic oedema, visual impairment, dysphonia, encephalopathy, multiple sclerosis relapse, hemiparesis on Apr 03, 2012 from CZECH REPUBLIC Additional patient health information: Female , 30 years of age, . Contraceptives Nos dosage: N/A.
Associated medications used:
  • Gilenya (0.5 Mg, Unk)
Patient was hospitalized.

Headache, Rash, Haematochezia, Dry Mouth (8166600-0)
Adverse event was reported on Jun 09, 2011 by a Female taking Contraceptives (Dosage: N/A) . Location: UNITED STATES , 18 years of age, weighting 114.0 lb, Patient felt the following Contraceptives side effects: headache, rash, haematochezia, dry mouth.
Multiple prescriptions taken:
  • Amnesteem
  • Amnesteem
  • Amnesteem


Alopecia (8166104-5)
on Apr 01, 2011 Female from UNITED STATES , 34 years of age, weighting 150.0 lb, was treated with Contraceptives Nos. After Contraceptives was administered, patient encountered several Contraceptives side effects: alopecia. Contraceptives Nos dosage: N/A.
Multiple concurrent drugs taken:
  • Amnesteem


Diarrhoea, Urticaria, Swelling, Nausea, Chills, Headache (8152741-0)
on Feb 16, 2012 Female from UNITED STATES , 25 years of age, was diagnosed with
  • contraception
and was treated with Contraceptives Nos. Directly after, patient experienced the unwanted or unexpected Contraceptives side effects: diarrhoea, urticaria, swelling, nausea, chills, headache. Contraceptives Nos dosage: N/A.
Associated medications used:
  • Extra Strength Tylenol
  • Benadryl
  • Benadryl
  • Tylenol-500


Swelling, Injection Site Pruritus, Injection Site Warmth, Injection Site Erythema (8092466-3)
Patient was taking Contraceptives. Patient felt the following Contraceptives side effects: swelling, injection site pruritus, injection site warmth, injection site erythema on Jul 28, 2011 from UNITED STATES Additional patient health information: Female , 23 years of age, . Contraceptives dosage: N/A.
Multiple prescriptions taken:
  • Humira
  • Topamax


Tuberculin Test Positive (8086102-X)
Adverse event was reported on Jun 01, 2011 by a Female taking Contraceptives (Dosage: Pills) was diagnosed with
  • contraception
  • psoriatic arthropathy
  • hypertension
and. Location: UNITED STATES , weighting 172.2 lb, After Contraceptives was administered, patient encountered several Contraceptives side effects: tuberculin test positive.
Multiple concurrent drugs taken:
  • Humira
  • Benicar
  • Humira


No Adverse Event (8076791-8)
on Jan 24, 2012 Female from UNITED STATES , 28 years of age, weighting 138.9 lb, was treated with Contraceptives Nos. Directly after, patient experienced the unwanted or unexpected Contraceptives side effects: no adverse event. Contraceptives Nos dosage: N/A.
Associated medications used:
  • Aleve (caplet)


Hypoaesthesia, Cerebrovascular Accident (8031658-6)
on Jan 06, 2012 Female from IRELAND , 29 years of age, weighting 132.3 lb, was treated with Contraceptives. Patient felt the following Contraceptives side effects: hypoaesthesia, cerebrovascular accident. Contraceptives dosage: N/A.
Multiple prescriptions taken:
  • Pradaxa
Patient was hospitalized and became disabled.

Vaginal Haemorrhage (8016610-9)
Patient was taking Contraceptives Nos. After Contraceptives was administered, patient encountered several Contraceptives side effects: vaginal haemorrhage on Dec 23, 2011 from UNITED KINGDOM Additional patient health information: Female , 25 years of age, . Contraceptives Nos dosage: N/A.
Multiple concurrent drugs taken:
  • Clotrimazole (Unk)


Sinus Tachycardia, Diarrhoea, Heart Rate Increased, Supraventricular Tachycardia, Lymphocyte Count Decreased, Neutrophil Count Increased, Chest Discomfort, Dyspnoea, Chest Pain (8014367-9)
Adverse event was reported on Dec 21, 2011 by a Female taking Contraceptives (Dosage: Unk Ukn, Unk) . Location: UNITED STATES , weighting 157.4 lb, Directly after, patient experienced the unwanted or unexpected Contraceptives side effects: sinus tachycardia, diarrhoea, heart rate increased, supraventricular tachycardia, lymphocyte count decreased, neutrophil count increased, chest discomfort, dyspnoea, chest pain.
Associated medications used:
  • Gilenya (0.5 Mg, Daily)
  • Levetiracetam
  • Nortriptyline Hcl (125 Mg, Unk)
  • Vitamin D (50 Kiu, Weekly)
  • Keppra (500 Mg, Bid)
  • Nuvigil (150 Mg, Daily)
Patient was hospitalized.

Cholecystectomy, Cholecystitis Chronic (8011629-6)
on Dec 19, 2011 Female from UNITED STATES , 30 years of age, was diagnosed with
  • premenstrual syndrome
and was treated with Contraceptives Nos. Patient felt the following Contraceptives side effects: cholecystectomy, cholecystitis chronic. Contraceptives Nos dosage: Unk.
Multiple prescriptions taken:
  • Multi-vitamin
  • Imitrex (Unk)
  • Atenolol (25 Mg, Daily)
  • Zoloft (50 Mg, Daily)
  • Nsaid's
  • Yaz (Unk)
  • Yaz
  • Yasmin (Unk)


Procedural Pain (7983046-6)
on Dec 13, 2011 Female from UNITED STATES , 18 years of age, was treated with Contraceptives Nos. After Contraceptives was administered, patient encountered several Contraceptives side effects: procedural pain. Contraceptives Nos dosage: N/A.
Multiple concurrent drugs taken:
  • Mirena (20 Mcg/24hr, Cont)


Cerebrovascular Accident, Hypoaesthesia (7949158-8)
Patient was taking Contraceptives. Directly after, patient experienced the unwanted or unexpected Contraceptives side effects: cerebrovascular accident, hypoaesthesia on Nov 28, 2011 from IRELAND Additional patient health information: Female , 29 years of age, weighting 132.3 lb, . Contraceptives dosage: N/A.
Associated medications used:
  • Pradaxa
Patient was hospitalized and became disabled.

Multiple Sclerosis Relapse, Cognitive Disorder, Hemiparesis, Headache, Aggression, Brain Oedema, Dehydration, Influenza, Convulsion (7944653-X)
Adverse event was reported on Jul 06, 2011 by a Female taking Contraceptives Nos (no Ingredients/substances) (Dosage: N/A) . Location: UNITED STATES , 31 years of age, Patient felt the following Contraceptives side effects: multiple sclerosis relapse, cognitive disorder, hemiparesis, headache, aggression, brain oedema, dehydration, influenza, convulsion.
Multiple prescriptions taken:
  • Lexapro (escitalopram Oxalate), 5 Mg
  • Trazodone (trazodone), 50 Mg
  • Gilenya (Unk Ukn, Unk, Oral)
Patient was hospitalized.

Cerebrovascular Accident, Hypoaesthesia (7927332-4)
on Nov 16, 2011 Female from IRELAND , 29 years of age, weighting 132.3 lb, was treated with Contraceptives. After Contraceptives was administered, patient encountered several Contraceptives side effects: cerebrovascular accident, hypoaesthesia. Contraceptives dosage: N/A.
Multiple concurrent drugs taken:
  • Pradaxa
Patient was hospitalized and became disabled.

Pulmonary Embolism (7916132-7)
on Nov 09, 2011 Female from NORWAY , 43 years of age, was treated with Contraceptives. Directly after, patient experienced the unwanted or unexpected Contraceptives side effects: pulmonary embolism. Contraceptives dosage: N/A.
Associated medications used:
  • Tysabri
Patient was hospitalized.

Showing 1-25 of 45 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Contraceptives Information

More About Contraceptives

Side Effects reported to FDA: 45. View Contraceptives Adverse Reports

Contraceptives safety alerts: 2011

Reported hospitalizations: 8

Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error

includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20,  Orsythia, Previfem, Tri-Previfem

 

[Posted 09/16/2011]

AUDIENCE: Consumer, Pharmacy, OB/GYN

ISSUE: Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of oral contraceptives because a packaging error may result in the daily regimen for these products being  incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible.

BACKGROUND: These packaging defects do not pose any immediate health risks. Pharmacies are being instructed to contact consumers who have received affected product.

RECOMMENDATION: Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist. Consumers who have affected products should contact Qualitest for information or to arrange return of any affected product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[09/15/2011 - Press Release - Qualitest Pharmaceuticals]

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