Psychiatric disorders symptoms and conditions

Sorry the link does seem to work so you can click on the main site and the go to search , then type MIRENA SIDE EFFECTS , if not here is what it says

Adverse effects
Serious side effects
If a pregnancy occurs in the case of method failure, the risk that it may be ectopic (located outside the womb) is increased. This requires immediate medical attention (see symptoms listed in the section "What else you should know"). Pelvic inflammatory disease, which may be serious, can occur during the use of the IUS. Enlarged ovarian follicles may require medical attention. MIRENA may pierce the wall of the womb. In addition, cases of breast cancer have been reported (frequency unknown).

Other possible side effects
It is perfectly normal for you to experience changes in menstrual bleeding patterns during the use of MIRENA. The changes may include spotting, shorter or longer menstrual periods, irregular bleeding, prolonged interval of bleeding or no bleeding at all, heavy flow and menstrual pain.

Ovarian cysts have been detected in 12% of women during the use of MIRENA.

Allergic skin reactions may be due to the IUS.

In addition, the following undesirable effects that may be associated with MIRENA have been reported. These side effects have been listed by the parts of the body that they may affect and how common they are.

The following definitions apply when the words "common", "uncommon" and "rare" appear in this leaflet relating to adverse effects:

"very common" means more than 1 in every 10 patients may experience these.
"common" means between 1 and 10 in every 100 patients may experience these.
"uncommon" means between 1 and 10 in every 1,000 patients may experience these.
"rare" means between 1 and 10 in every 10,000 patients may experience these.

Nervous System and Psychiatric Disorders
Common - headache
- depression
- nervousness
- decreased libido
Uncommon - migraine
- altered mood
Digestive System
Common -abdominal pain
- nausea (feeling sick)
Uncommon - abdominal bloating
Skin and Subcutaneous Disorders
Common - acne
Uncommon - excessive body hair (hirsuitism)
- hair loss
- severe itching (pruritis)
- inflammation of the skin (eczema)
Rare - rash
- hives (urticaria)
Musculoskeletal, Connective Tissue and Bone Disorders
Common - back pain
Reproductive System Disorders
Very Common - uterine or vaginal bleeding including spotting, infrequent periods
(oligomenorrhea), and absence of bleeding (amenorrhea)
- benign ovarian cysts (see the section called "Enlarged ovarian follicles")
Common - pelvic pain
- painful menstruation (dysmenorrhea)
- vaginal discharge
- inflammation of the external genital organs or vagina (vulvovaginitis)
- breast tenderness
- breast pain
- expulsion of MIRENA
Uncommon - pelvic inflammatory disease (infection of the female upper genital tract, the female structures above the neck of the womb)
- inflammation of the lining of the womb (endometritis)
- inflammation of the neck of the womb (cervicitis/Papanicalaou smear normal, class II)
Rare - perforation of the womb
Investigations
Common - weight gain
General Disorders
Uncommon - swelling (edema)

Similar side effects have been reported when MIRENA has been used for hormone replacement therapy in combination with estrogen preparations.

These side effects are more common during the first months after insertion, and subside during prolonged use.

If you are concerned about any of these side effects or notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Storage
Do not use after the expiry date stated on the package.

Store all medicines properly and keep them out of reach of children.

Further information
MIRENA contains:
active substances (per implant)
levonorgestrel (52 mg)

other substances
polydimethylsiloxane elastomer, silica (colloidal anhydrous), polyethylene, barium sulphate, iron oxide

If you have any further questions please consult your doctor or pharmacist.

Sponsor
*******

This leaflet was last revised on 29th May 2007

STRANGELY ENOUGH THE CORRECT INFORMATION IS SHOWING UP IF YOU HIT REPLY SO DO THAT!

GUESS WHAT, WHEN YOU CUT AND PASTE THE SIDE EFFECTS INTO THIS WEBSITE THEY DON'T ALL SHOW UP!

MISSING IS:

BEHAVIOR AND MOOD RELATED CHANGES

CHECK FOR YOURSELF ON THEIR WEBSITE BECAUSE THEY ARE THERE!

MY APOLOGIES TO ALL FOR AN ERROR IN MY PRIOR POST. WHEN I CUT AND PASTED THE INFORMATION FROM MERCK'S WEBSITE NOT ALL OF IT APPEARED IN MY POST FOR SOME REASON. THE CORRECTED INFORMATION IS BELOW. CHECK THEIR WEBSITE FOR YOURSELVES TO VERIFY THIS.

THIS IS FROM THE PATIENT INFORMATION:

"What are the possible side effects of SINGULAIR?

The side effects of SINGULAIR are usually mild, and generally did not cause patients to stop taking their medicine. The side effects in patients treated with SINGULAIR were similar in type and frequency to side
effects in patients who were given a placebo (a pill containing no medicine).
The most common side effects with SINGULAIR include:
• stomach pain
• stomach or intestinal upset
• heartburn
• tiredness
• fever
• stuffy nose
• cough
• flu
• upper respiratory infection
• dizziness
• headache
• rash

Less common side effects that have happened with SINGULAIR include:
• increased bleeding tendency
• allergic reactions
• behavior and mood related changes
• drowsiness, pins and needles/numbness, seizures (convulsions or fits)
• palpitations
• nose bleed
• diarrhea, indigestion, inflammation of the pancreas, nausea, vomiting
• hepatitis
• bruising
• joint pain, muscle aches and muscle cramps
• swelling

Rarely, asthmatic patients taking SINGULAIR have experienced Rarely, asthmatic patients taking SINGULAIR have experienced a condition that includes certain symptoms that do not go away or that get worse. These occur usually, but not always, in patients who were taking steroid pills by mouth for asthma and those steroids were being slowly lowered or stopped.
Although SINGULAIR has not been shown to cause this condition, you must tell your doctor right away if you get one or more of these symptoms:
• a feeling of pins and needles or numbness of arms or legs
• a flu-like illness
• rash
• severe inflammation (pain and swelling) of the sinuses (sinusitis)
These are not all the possible side effects of SINGULAIR. For more information ask your doctor or pharmacist.
Talk to your doctor if you think you have side effects from taking SINGULAIR."

d27gayle POSTED INCORRECT INFORMATION ABOUT THE SIDE EFFECTS OF SINGULAIR. I JUST COPIED THIS FROM MERCK'S SINGULAIR WEBSITE. THIS IS THE CORRECT AND UPDATED INFORMATION. THIS INFORMATION DOES LIST DEPRESSION AND SUICIDAL BEHAVIOR AS SIDE EFFECTS.

IF PEOPLE ARE GOING TO SHARE INFORMATION ON THIS SITE, PLEASE MAKE SURE IT IS CORRECT BEFORE POSTING!!!!!!!!!

What are the possible side effects of SINGULAIR?
The side effects of SINGULAIR are usually mild, and generally did not cause patients to stop taking their medicine. The side effects in patients treated with SINGULAIR were similar in type and frequency to side effects in patients who were given a placebo (a pill containing no medicine).
The most common side effects with SINGULAIR include:
• stomach pain
• stomach or intestinal upset
• heartburn
• tiredness
• fever
• stuffy nose
• cough
• flu
• upper respiratory infection
dizziness
• headache
• rash

Less common side effects that have happened with SINGULAIR include:
• increased bleeding tendency
• allergic reactions
• behavior and mood related changes
• drowsiness, pins and needles/numbness, seizures (convulsions or fits)
• palpitations
• nose bleed
• diarrhea, indigestion, inflammation of the pancreas, nausea, vomiting
• hepatitis
• bruising
• joint pain, muscle aches and muscle cramps
• swelling

Rarely, asthmatic patients taking SINGULAIR have experienced a condition that includes certain
symptoms that do not go away or that get worse. These occur usually, but not always, in patients who
were taking steroid pills by mouth for asthma and those steroids were being slowly lowered or stopped.
Although SINGULAIR has not been shown to cause this condition, you must tell your doctor right
away if you get one or more of these symptoms:
• a feeling of pins and needles or numbness of arms or legs
• a flu-like illness
• rash
• severe inflammation (pain and swelling) of the sinuses (sinusitis)

These are not all the possible side effects of SINGULAIR. For more information ask your doctor or pharmacist. Talk to your doctor if you think you have side effects from taking SINGULAIR.

Below is the latest ADR report on Singulair from the United Kingdom. I deleted side effects reports by very small numbers of patients in order to keep the post briefer. This shows the total number of reports since Singulair was approved in the UK.

I don't know the total number of prescriptions for Singulair in the UK. It is considered expensive.

Drug Analysis Print
Drug name: MONTELUKAST
Drug name: MONTELUKAST Report type: Spontaneous
Report run date: 13-May-2008 Report origin: UNITED KINGDOM
Data lock date: 09-May-2008 08:00:02 PM Route of admin: ALL
Period covered: 01-Jul-1963 to 09-May-2008 Reporter type: ALL
Earliest reaction date: 01-Jan-1997 Reaction: ALL

Cardiac disorders-TOTAL 64
Palpitations 29
Myocardial infarction 6
Tachycardia 6
Diarrhoea 84
Dyspepsia 24
Abdominal pain 98
Abdominal pain upper 22
Nausea 84
Vomiting 52
Dry mouth 15
Asthenia 13
Fatigue 45
Malaise 32
Sudden death 1
Pyrexia 10
Chest discomfort 12
Feeling abnormal 16
Influenza like illness 17
Irritability 18
Drug interaction 13
Chest pain 13
Arthralgia 59
Myalgia 38
Muscle spasms 24
Pain in extremity 14
Balance disorder 10
Lethargy 16
Somnolence 23
Psychomotor hyperactivity 25
Headache 221
Dizziness 68
Neuropathy peripheral 7
Convulsion 6
Epilepsy 7
Dysgeusia 7
Hypoaesthesia 6
Tremor 18
Nervous system disorders TOTAL 526
Abnormal behaviour 13
Agitation 12
Anxiety 18
Aggression 30
Depression 23
Insomnia 58
Abnormal dreams 12
Nightmare 49
Hallucination 21
Sleep disorder 15
Psychiatric disorders TOTAL 364
Asthma 36
Allergic granulomatous angiitis 43
Angioedema 12
Swelling face 12
Erythema 13
Pruritus 32
Rash pruritic 17
Rash 55
Urticaria 33

TOTAL NUMBER OF REACTIONS 2841
TOTAL NUMBER OF FATAL ADR REPORTS* 19
TOTAL NUMBER OF ADR REPORTS* 1489

From a UK Yellow Card Report.

Montelukast

The product information for montelukast has been amended to include the following ADRs: Reaction No. of UK Yellow Card reports

Nausea 63 Diarrhoea 54 Rashes 52 Insomnia 44 Dizziness 42 Fatigue 37 Vomiting 24 Pruritus 24 Arthralgia 20 Urticaria 19 Malaise 18 Dyspepsia 13 Myalgia 12 Dry mouth 9 Anaphylaxis 4 Angioedema3

In addition, the following suspected ADRs have been reported and are still being evaluated: psychiatric disorders (63) ; also nightmares (13), sedation (13), palpitations (12), tremor (10) and increased sweating (10).
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Zafirlukast The most frequently reported ADRs under the Yellow Card Scheme for zafirlukast have been rashes (7), headache (7), abdominal pain (6), nausea (6) and pruritus (5). All of these are included in the product information which has also been updated to include the following ADRs that have been identified from data other than UK Yellow Card reports: urticaria, angioedema, blistering, bruising, bleeding disorders, including menorrhagia (rare), thrombocytopenia and agranulocytosis (both very rare). Churg-Strauss syndrome Churg-Strauss syndrome (CSS) is a rare syndrome characterised by a history of asthma, and often rhinitis and sinusitis, with systemic vasculitis and eosinophilia. There has been a recent increase in the number of reports of CSS associated with the use of anti-asthma drugs, particularly the leukotriene receptor antagonists. The MHRA/CSM have received 63 reports of CSS through the Yellow Card Scheme since 1963, 59 since the beginning of 1998; Of these, 90% were associated with drugs used to treat asthma (mainly leukotriene receptor antagonists). In many, but not all cases there was documented evidence of a reduction or withdrawal of oral corticosteroid therapy prior to the onset of the reaction. There are clear warnings regarding the possible association with CSS in the product information for montelukast and zafirlukast. Prescribers should be aware of the possibility that, although rare, CSS may be the underlying cause of asthma in their patients. In patients prescribed a leukotriene receptor antagonist prescribers should be alert to the development of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications and/or peripheral neuropathy. The identification of new and suspected ADRs emphasises the important role of the Yellow Card Scheme in helping to ensure the safe use of medicines. The safety profile of leukotriene receptor antagonists remains under close review. Please continue to report all suspected ADRs to montelukast (Singulairt) and zafirlukast (Accolatet) through the Yellow Card Scheme.1. MHRA/CSM Current Problems in Pharmacovigilance 1998; 24:14.
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http://64.233.169.104/search?q=cache:3fU602hhlG8J:www.mhra.gov.uk/home/groups/pl-p/documents/publication/con2023236.pdf+montelukast+ADR&hl=en&ct=clnk&cd=10&gl=us

From England 1998:

Montelukast

Montelukast (Singulair) is a leukotriene antagonist for use as an add-on therapy in patients with mild to moderate asthma who are inadequately controlled by inhaled corticosteroids and short acting beta2-agonists. Since it was marketed in January 1998, CSM Mersey has received 31 yellow cards detailing 47 suspected reactions to montelukast including:
• 15 (32%) CNS disorders including headache and drowsiness
• 14 (30%) GI disorders including abdominal pain and indigestion
• 5 (11%) skin disorders including sweating
• 7 (15%) musculoskeletal disorders including arthralgia and cramps
• 2 (4%) psychiatric disorders.
26 of these reactions were not listed in the Summary of Product Characteristics at the time of reporting.

http://www.liv.ac.uk/~druginfo/csm/ADR_bulletin14.pdf